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12 Diseases |  |
15 Trials |
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15 Trials |  |
482 News |  |
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- || Verzenio (abemaciclib) / Eli Lilly
Trial completion date, Trial primary completion date, Combination therapy: A Study of Abemaciclib (LY2835219) in Combination With Other Anti-Cancer Treatments in Children and Young Adult Participants With Solid Tumors, Including Neuroblastoma (clinicaltrials.gov) - Jun 21, 2024
P1/2, N=117, Active, not recruiting, Sponsor: Eli Lilly and Company
Trial completion date: Oct 2028 --> Apr 2025 | Trial primary completion date: May 2028 --> Mar 2024
- || Verzenio (abemaciclib) / Eli Lilly
Enrollment closed, Combination therapy: A Study of Abemaciclib (LY2835219) in Combination With Other Anti-Cancer Treatments in Children and Young Adult Participants With Solid Tumors, Including Neuroblastoma (clinicaltrials.gov) - May 6, 2024
P1/2, N=117, Active, not recruiting, Sponsor: Eli Lilly and Company
Trial completion date: Oct 2028 --> Apr 2025 | Trial primary completion date: May 2028 --> Mar 2024 Recruiting --> Active, not recruiting
- | Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
Enrollment open, Surgery: Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma (clinicaltrials.gov) - Apr 30, 2024
P3, N=478, Recruiting, Sponsor: National Cancer Institute (NCI)
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- | Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma, magrolimab (GS-4721) / Ono Pharma
Enrollment closed: Testing the Combination of Two Immunotherapy Drugs (Magrolimab and Dinutuximab) in Patients With Relapsed or Refractory Neuroblastoma or Relapsed Osteosarcoma (clinicaltrials.gov) - Apr 30, 2024
P1, N=82, Active, not recruiting, Sponsor: National Cancer Institute (NCI)
Not yet recruiting --> Recruiting Suspended --> Active, not recruiting
- Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
Efficacy and safety of dinutuximab in the management of high-risk neuroblastoma: A systematic review and meta-analysis. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5059;
Suspended --> Active, not recruiting Our findings suggest that dinutuximab is linked to a significant reduction in overall mortality and a noteworthy improvement in the 5-Year-EFS for patients with HR-NB, when compared to other treatment options.
- Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
Efficacy and safety of the use of dinutuximab in newly diagnosed or relapse high risk neuroblastoma: Single arm systematic review and meta-analysis. (Hall A; Poster Bd #: 411) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3414;
This single-arm meta-analysis suggests that both newly diagnosed or relapsed/refractory high-risk Neuroblastoma patients benefit from Dinutuximab, with a promising impact on 3-year OS and EFS. Dinutuximab appears to be a safer option; however, concomitant use of IL2 is associated with a higher rate of adverse effects.
- Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
Preliminary experience of ex-vivo expanded allogeneic universal donor TGF?i NK cell infusions in combination with irinotecan, temozolomide, and dinutuximab in patients with relapsed or refractory neuroblastoma: The Allo - STING trial. (S100bc) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2741;
P1/2
UD allo-TGF?i NK cells can be safely and feasibly administered to children with RR NBL after treatment with CIT, with early objective responses observed in the preliminary cohort of patients. Ongoing studies will assess markers of response, NK cell persistence, pharmacokinetics and pharmacodynamics.
- Leukine (sargramostim) / Partner Therap, humanised dinutuximab (Hu14.18K322A) / Essential Pharma, Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
A pilot study of post-consolidation chemoimmunotherapy for high-risk neuroblastoma (ANBL19P1): A report from the Children's Oncology Group. (S100bc) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2740;
P2
Administration of post-consolidation chemoimmunotherapy in pts who underwent tandem ASCT is tolerable and met pre-defined feasibility criteria. The impact of this approach on survival outcomes will be studied in a future COG trial.
- | Leukine (sargramostim) / Partner Therap, Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
Trial completion: Safety Study of Dinutuximab Combined With Immunotherapy to Treat Neuroblastoma (clinicaltrials.gov) - Apr 22, 2024
P2, N=24, Completed, Sponsor: Fundaci
The impact of this approach on survival outcomes will be studied in a future COG trial. Unknown status --> Completed
- | Leukine (sargramostim) / Partner Therap, Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
Trial completion date: NCI-2018-03732: Dinutuximab, Sargramostim, and Combination Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma (clinicaltrials.gov) - Apr 17, 2024
P2, N=42, Active, not recruiting, Sponsor: National Cancer Institute (NCI)
Unknown status --> Completed Trial completion date: Dec 2023 --> Sep 2024
- | Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
Journal, CAR T-Cell Therapy: Choosing T-cell sources determines CAR-T cell activity in neuroblastoma. (Pubmed Central) - Apr 15, 2024
Moreover, ex vivo culture with IL-7+IL-15+IL-21 could favor CAR-T products with a longer persistence in the host. Our strategy may complement the current use of Dinutuximab in treating NB through its combination with a targeted CAR-T cell approach.
- | Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
Trial completion date: NANT: Lenalidomide and Dinutuximab With or Without Isotretinoin in Treating Younger Patients With Refractory or Recurrent Neuroblastoma (clinicaltrials.gov) - Mar 7, 2024
P1, N=27, Active, not recruiting, Sponsor: National Cancer Institute (NCI)
- Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
Evaluation of the association between sickle cell disease and breast cancer using the All of Us Research Program dataset (Section 33) - Mar 5, 2024 - Abstract #AACR2024AACR_5850;
Further investigation is warranted for dinutuximab use in BC treatment, specifically the triple negative subtype, as currently no targeted therapeutic options exist, and prognosis is poor. The data suggests dinutuximab with adjunctive interferon-alpha may be promising for triple-negative BC patients with SCD.
- | Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
Trial completion date, Trial primary completion date: Irinotecan Hydrochloride, Temozolomide, and Dinutuximab With or Without Eflornithine in Treating Patients With Relapsed or Refractory Neuroblastoma (clinicaltrials.gov) - Mar 2, 2024
P2, N=95, Active, not recruiting, Sponsor: Children's Oncology Group
The data suggests dinutuximab with adjunctive interferon-alpha may be promising for triple-negative BC patients with SCD. Trial completion date: Jun 2024 --> Mar 2025 | Trial primary completion date: Jun 2024 --> Mar 2025
- | Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
Journal: Yoga as a non-pharmacologic therapy to reduce dinutuximab-induced pain in patients with neuroblastoma. (Pubmed Central) - Feb 26, 2024
Yoga therapy was feasible during DIN therapy and may be effective in reducing DIN-associated pain and distress. Future studies are needed to evaluate changes in opioid usage with the addition of yoga therapy during anti-GD2 antibody therapy.
- ||| Danyelza (naxitamab) - Y / mAbs Therap, Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
Journal, Adverse events, Real-world evidence, Real-world: Toxicity Spectrum of Anti-GD2 Immunotherapy: A Real-World Study Leveraging the US Food and Drug Administration Adverse Event Reporting System. (Pubmed Central) - Feb 26, 2024
Future studies are needed to evaluate changes in opioid usage with the addition of yoga therapy during anti-GD2 antibody therapy. Our study comprehensively analyzed the toxicity profiles of anti-GD2 monoclonal antibodies and provides an important reference for clinical monitoring and ADR identification of these drugs.
- | Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
Trial primary completion date, Combination therapy: STING: NK Cells Infusions With Irinotecan, Temozolomide, and Dinutuximab (clinicaltrials.gov) - Feb 15, 2024
P1/2, N=31, Recruiting, Sponsor: Nationwide Children's Hospital
Our study comprehensively analyzed the toxicity profiles of anti-GD2 monoclonal antibodies and provides an important reference for clinical monitoring and ADR identification of these drugs. Trial primary completion date: Dec 2023 --> Dec 2024
- || Verzenio (abemaciclib) / Eli Lilly
Phase classification, Trial primary completion date, Combination therapy: A Study of Abemaciclib (LY2835219) in Combination With Other Anti-Cancer Treatments in Children and Young Adult Participants With Solid Tumors, Including Neuroblastoma (clinicaltrials.gov) - Jan 25, 2024
P1/2, N=117, Recruiting, Sponsor: Eli Lilly and Company
Trial primary completion date: Dec 2023 --> Dec 2024 Phase classification: P1b/2 --> P1/2 | Trial primary completion date: Jun 2027 --> May 2028
- | humanised dinutuximab (Hu14.18K322A) / Essential Pharma
Trial completion date, Metastases: Therapy for Children With Advanced Stage Neuroblastoma (clinicaltrials.gov) - Jan 16, 2024
P2, N=153, Active, not recruiting, Sponsor: St. Jude Children's Research Hospital
Phase classification: P1b/2 --> P1/2 | Trial primary completion date: Jun 2027 --> May 2028 Trial completion date: Dec 2023 --> Dec 2024
- | Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
Journal: Persistence of Racial and Ethnic Disparities in Risk and Survival for Patients with Neuroblastoma over Two Decades. (Pubmed Central) - Jan 12, 2024
Trial completion date: Dec 2023 --> Dec 2024 Racial/ethnic survival disparities have persisted over time and were observed among high-risk patients assigned to receive post-Consolidation dinutuximab.
- | Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma, magrolimab (GS-4721) / Ono Pharma
Trial completion date, Trial primary completion date: Testing the Combination of Two Immunotherapy Drugs (Magrolimab and Dinutuximab) in Patients With Relapsed or Refractory Neuroblastoma or Relapsed Osteosarcoma (clinicaltrials.gov) - Jan 11, 2024
P1, N=82, Suspended, Sponsor: National Cancer Institute (NCI)
Racial/ethnic survival disparities have persisted over time and were observed among high-risk patients assigned to receive post-Consolidation dinutuximab. Trial completion date: Jun 2026 --> Dec 2032 | Trial primary completion date: Jun 2026 --> Dec 2032
- | ex vivo expanded allogeneic ?? T Cells / Emory University
Trial completion date, Trial primary completion date, Combination therapy: Aflac-NBL-2002: Allogeneic Expanded Gamma Delta T Cells With GD2 Chemoimmunotherapy in Relapsed or Refractory Neuroblastoma (clinicaltrials.gov) - Dec 31, 2023
P1, N=24, Recruiting, Sponsor: Emory University
- | Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
Journal: Eflornithine as Postimmunotherapy Maintenance in High-Risk Neuroblastoma: Externally Controlled, Propensity Score-Matched Survival Outcome Comparisons. (Pubmed Central) - Dec 25, 2023
P2, P3
Trial completion date: Jun 2026 --> Dec 2032 | Trial primary completion date: Jun 2026 --> Dec 2032 The externally controlled analyses presented show a relapse risk reduction in patients with HRNB treated with postimmunotherapy DFMO.
- || Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
Review, Journal: Safety and efficacy of dinutuximab in the treatment of neuroblastoma: A review. (Pubmed Central) - Dec 20, 2023
Recent studies on relapsed and refractory NB have shown the potential efficacy of dinutuximab. Further research is required to properly incorporate Dinutuximab in current treatment modalities.
- | Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
New P3 trial, Surgery: Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma (clinicaltrials.gov) - Dec 15, 2023
P3, N=478, Not yet recruiting, Sponsor: National Cancer Institute (NCI)
- Anktiva (inbakicept) / ImmunityBio
IL15 (N-803) and IL21 (oHSV-21) Significantly Enhance ROR1 CAR NK Cells Against Pediatric Neuroblastoma () - Dec 11, 2023 - Abstract #TCTASTCTCIBMTR2024TCT_ASTCT_CIBMTR_1267;
The N-803 combined with dinutuximab and exPBNK cells significantly extended the survival of NB xenografts (Chu/Cairo, et al, JITC...C021 was generated by modifying C134 to express human IL21 gene... Our data demonstrated IL15 or IL21 based novel cytokine therapy (N-803 or C021) significantly enhanced the anti-tumor efficacy of ROR1 CAR NK targeting NB in vitro and in vivo (Funded by U54 CA232561).
- Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma, NKTR-255 / Nektar Therap
Targeting Ewing Sarcoma By Genetically and Epigenetically Modified Ex-Vivo Expanded NK Cells in Combination with NKTR-255 and Dinutuximab (221 (Meeting Level, Henry B. Gonzalez Convention Center); in-person) - Dec 11, 2023 - Abstract #TCTASTCTCIBMTR2024TCT_ASTCT_CIBMTR_739;
Conclusions Our data demonstrated enhanced anti-tumor efficacy of modified NK (IL1RAP CAR NK, TGF?i-NK, IL1RAP CAR CXCR2 NK) cells alone and combined with NKTR-255 and dinutuximab against ES in vitro. This provided a rationale for a preclinical evaluation of the anti-tumor effects of these modified NK cells combined with NKTR-255 and dinutuximab in vivo.
- | Leukine (sargramostim) / Partner Therap, Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
Trial completion, Combination therapy: Dinutuximab in Combination With Sargramostim in Treating Patients With Recurrent Osteosarcoma (clinicaltrials.gov) - Oct 25, 2023
P2, N=41, Completed, Sponsor: National Cancer Institute (NCI)
This provided a rationale for a preclinical evaluation of the anti-tumor effects of these modified NK cells combined with NKTR-255 and dinutuximab in vivo. Active, not recruiting --> Completed
- | Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
Trial completion date, Trial primary completion date: NANT 2013-01: Immunotherapy of Relapsed Refractory Neuroblastoma With Expanded NK Cells (clinicaltrials.gov) - Oct 16, 2023
P1, N=13, Active, not recruiting, Sponsor: New Approaches to Neuroblastoma Therapy Consortium
Active, not recruiting --> Completed Trial completion date: Sep 2023 --> Sep 2024 | Trial primary completion date: Sep 2023 --> Sep 2024
- | Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
Journal: A Multi-Color Flow Cytometric Assay for Quantifying Dinutuximab Binding to Neuroblastoma Cells in Tumor, Bone Marrow, and Blood. (Pubmed Central) - Oct 14, 2023
As the most common clinical samples available for relapsed neuroblastoma are bone marrow aspirates, we developed a method to quantify dinutuximab binding density and the frequency of neuroblastoma cells positive for the antibody in bone marrow aspirates. Here, we describe a multi-color flow cytometry assay that employs non-GD2 antibodies to identify neuroblastoma cells in a mixed population (tumor, bone marrow, or blood) and an anti-GD2 antibody to quantify both the frequency and density of GD2 expression on neuroblastoma cells.
- | Lorbrena (lorlatinib) / Pfizer, Azedra (iobenguane I 131) / Lantheus
Enrollment closed: Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL) (clinicaltrials.gov) - Oct 3, 2023
P3, N=724, Active, not recruiting, Sponsor: Children's Oncology Group
Here, we describe a multi-color flow cytometry assay that employs non-GD2 antibodies to identify neuroblastoma cells in a mixed population (tumor, bone marrow, or blood) and an anti-GD2 antibody to quantify both the frequency and density of GD2 expression on neuroblastoma cells. Recruiting --> Active, not recruiting
- | Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
Journal: Survival and Local Recurrence Risk in Patients with High-Risk Neuroblastoma Treated with Proton Therapy over a 10 Year Interval. (Pubmed Central) - Oct 3, 2023
A small number of pts received 21.6 Gy after STR, however, this experience suggests that a subset of pts with RD may require RT dose > 21.6 Gy. Further work is required to further characterize individual management of PS in pts with HR-NBL with regard to extent of RD and biologic disease features.
- Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
Survival and Local Recurrence Risk in Patients with High-Risk Neuroblastoma Treated with Proton Therapy over a 10 Year Interval (Hall B2; In Person Only; Screen: 7) - Oct 2, 2023 - Abstract #ASTRO2023ASTRO_2590;
Our data suggest that LR is rare after GTR and 21.6 Gy, and uncommon among pts with STR treated with 36 Gy. A small number of pts received 21.6 Gy after STR, however, this experience suggests that a subset of pts with RD may require RT dose > 21.6 Gy.
- | Leukine (sargramostim) / Partner Therap, Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
Trial completion date, Trial primary completion date, Combination therapy: Treatment With Dinutuximab, Sargramostim (GM-CSF), and Isotretinoin in Combination With Irinotecan and Temozolomide After Intensive Therapy for People With High-Risk Neuroblastoma (NBL) (clinicaltrials.gov) - Oct 2, 2023
P2, N=34, Active, not recruiting, Sponsor: Children's Oncology Group
A small number of pts received 21.6 Gy after STR, however, this experience suggests that a subset of pts with RD may require RT dose > 21.6 Gy. Trial completion date: Dec 2023 --> Sep 2024 | Trial primary completion date: Dec 2023 --> Jun 2023
- Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
Enrollment open: Rapid Administration Pilot for Infusing Dinutuximab (clinicaltrials.gov) - Sep 28, 2023
P4, N=11, Recruiting, Sponsor: Children's Hospital Los Angeles
Trial completion date: Dec 2023 --> Sep 2024 | Trial primary completion date: Dec 2023 --> Jun 2023 Not yet recruiting --> Recruiting
- | Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
Journal: Treatment of High-Risk Neuroblastoma with Dinutuximab and Chemotherapy Administered in all Cycles of Induction. (Pubmed Central) - Sep 28, 2023
The EOI response of PR or better in the evaluable cohort was 96%. Dinutuximab was well tolerated with all Induction cycles, demonstrated an encouraging EOI response rate, and should be evaluated in a randomized study.
- | Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
Journal, HEOR, Cost-effectiveness, Cost effectiveness: Cost-effectiveness analysis of dinutuximab ? for the treatment of high-risk neuroblastoma in China. (Pubmed Central) - Sep 16, 2023
Results found that dinutuximab ? is not a cost-effective treatment option for children with high-risk NB unless its price is significantly reduced.
- | Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma, magrolimab (GS-4721) / Ono Pharma
Trial completion date, Trial primary completion date: Testing the Combination of Two Immunotherapy Drugs (Magrolimab and Dinutuximab) in Patients With Relapsed or Refractory Neuroblastoma or Relapsed Osteosarcoma (clinicaltrials.gov) - Sep 13, 2023
P1, N=82, Suspended, Sponsor: National Cancer Institute (NCI)
is not a cost-effective treatment option for children with high-risk NB unless its price is significantly reduced. Trial completion date: Jan 2024 --> Jun 2026 | Trial primary completion date: Jan 2024 --> Jun 2026
- | Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
Journal, IO biomarker: The yes-associated protein (YAP) is associated with resistance to anti-GD2 immunotherapy in neuroblastoma through downregulation of ST8SIA1. (Pubmed Central) - Aug 13, 2023
Patients with relapsed neuroblastoma are often treated with immunotherapy such as the anti-GD2 antibody, dinutuximab, in combination with chemotherapy...The mechanism of ST8SIA1 suppression by YAP is independent of PRRX1 expression, a mesenchymal master transcription factor, suggesting YAP may be the downstream effector of mesenchymal GD2 resistance. These results therefore identify YAP as a therapeutic target to augment GD2 immunotherapy responses in patients with neuroblastoma.
- | Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
Preclinical, Journal, IO biomarker: IgA antibody immunotherapy targeting GD2 is effective in preclinical neuroblastoma models. (Pubmed Central) - Jul 26, 2023
These results therefore identify YAP as a therapeutic target to augment GD2 immunotherapy responses in patients with neuroblastoma. IgA3.0 ch14.18 is a promising new therapy for neuroblastoma, showing (1) increased half-life compared to natural IgA antibodies, (2) increased protein stability enabling effortless production and purification, (3) potent CD89-mediated tumor killing in vitro by healthy subjects and patients with neuroblastoma and (4) antitumor efficacy in long-term mouse neuroblastoma models.
- Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
Ketamine as an Adjunct to Opioid Analgesia in Pediatric Patients with High-risk Neuroblastoma Undergoing Treatment with Dinutuximab (South: Hall F) - Jul 20, 2023 - Abstract #ASA2023ASA_1636;
Daily average of IV morphine milligram equivalents (MME) and ketamine intake was calculated for each cycle of dinutuximab. Preliminary findings suggest an acceptable adverse effect profile with ketamine use as an adjunctive opioid therapy to relieve pain in pediatric patients receiving dinutuximab infusions.
- Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
Event-free survival (EFS) in patients with high-risk neuroblastoma (HRNB) receiving eflornithine (DFMO) maintenance treatment based on a retrospective, blinded independent central review (BICR) of imaging during long-term follow-up. () - Apr 26, 2023 - Abstract #ASCO2023ASCO_6665;
P3
Preliminary findings suggest an acceptable adverse effect profile with ketamine use as an adjunctive opioid therapy to relieve pain in pediatric patients receiving dinutuximab infusions. This BICR indicates minimal, if any, bias in imaging evaluations in the original NMTRC003B study, providing confidence in the finding that DFMO treatment in HNRB patients in remission post upfront dinutuximab approximately halves the risk of relapse compared to matched control patients.
- Verzenio (abemaciclib) / Eli Lilly
Phase 1b/2 study of abemaciclib combined with chemoimmunotherapy in pediatric and young adult patients with relapsed/refractory neuroblastoma (JPCS Part C). (On Demand | Hall A; Poster Bd # 373a) - Apr 26, 2023 - Abstract #ASCO2023ASCO_4074;
P1b/2
If ?26 of 46 total patients achieve an INRC minimum response or better, further investigation of this regimen could be warranted. As of 31 Jan 2023, Part C is open for enrollment at one site (US) and additional sites are being evaluated.
- | Leukine (sargramostim) / Partner Therap, Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
Enrollment closed, Combination therapy: Treatment With Dinutuximab, Sargramostim (GM-CSF), and Isotretinoin in Combination With Irinotecan and Temozolomide After Intensive Therapy for People With High-Risk Neuroblastoma (NBL) (clinicaltrials.gov) - Mar 31, 2023
P2, N=45, Active, not recruiting, Sponsor: Children's Oncology Group
As of 31 Jan 2023, Part C is open for enrollment at one site (US) and additional sites are being evaluated. Suspended --> Active, not recruiting
- | Leukine (sargramostim) / Partner Therap, Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
Trial suspension, Combination therapy: Treatment With Dinutuximab, Sargramostim (GM-CSF), and Isotretinoin in Combination With Irinotecan and Temozolomide After Intensive Therapy for People With High-Risk Neuroblastoma (NBL) (clinicaltrials.gov) - Mar 20, 2023
P2, N=45, Suspended, Sponsor: Children's Oncology Group
Suspended --> Active, not recruiting Active, not recruiting --> Suspended
- Danyelza (naxitamab) - Y / mAbs Therap, Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma, NKTR-255 / Nektar Therap
Novel humanized anti-GD2 antibody inhibits GD2-mediated immunosuppression by targeting GD2+ breast cancer stem-like cells (Section 22; Poster Board #18) - Mar 14, 2023 - Abstract #AACR2023AACR_7452;
Combination of naxitamab with macrophages induced macrophage mediated phagocytosis TNBC cells. NK cells were more stable and cytotoxic when generated with NKTR-255 vs.
- Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
The Yes-associated protein (YAP) regulates GD2 immunotherapy response in high-risk neuroblastoma (Section 1; Poster Board #25) - Mar 14, 2023 - Abstract #AACR2023AACR_6662;
T cells, dinutuximab, and cyclophosphamide. Pilot results show significantly extended survival in mice harboring SK-N-AS shYAP tumors.Conclusion These results support YAP regulation of GD2 expression through transcriptional suppression of GD3 synthase and identify YAP as a therapeutic target to augment GD2 immunotherapy responses in HR and relapsed NB.
- Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
Dual targeted CAR immunotherapy for neuroblastoma using ?? T cells (Section 23; Poster Board #12) - Mar 14, 2023 - Abstract #AACR2023AACR_6276;
P1
Future work will optimize CAR signaling domains for maximal efficacy in solid tumors, as well as confirm efficacy and safety in vivo with results rapidly translatable into our established ?? T cell clinical trial pipeline.
- | Leukine (sargramostim) / Partner Therap, Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
Trial completion date: NCI-2018-03732: Dinutuximab, Sargramostim, and Combination Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma (clinicaltrials.gov) - Mar 14, 2023
P2, N=42, Active, not recruiting, Sponsor: National Cancer Institute (NCI)
T cell clinical trial pipeline. Trial completion date: Jan 2023 --> Dec 2023
- || Zolinza (vorinostat) / Merck (MSD), Azedra (iobenguane I 131) / Lantheus, Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma
Enrollment closed: MIBG With Dinutuximab +/- Vorinostat (clinicaltrials.gov) - Mar 14, 2023
P1, N=45, Active, not recruiting, Sponsor: New Approaches to Neuroblastoma Therapy Consortium
Trial completion date: Jan 2023 --> Dec 2023 Recruiting --> Active, not recruiting