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- || Columvi (glofitamab-gxbm) / Roche, Lunsumio (mosunetuzumab-axgb) / Roche
Trial completion date, Trial primary completion date, Combination therapy: CO43805: A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab or Glofitamab in Combination With CC-220 and CC-99282 in Participants With B-Cell Non-Hodgkin Lymphoma (clinicaltrials.gov) - Oct 1, 2024
P1, N=121, Recruiting, Sponsor: Hoffmann-La Roche
Trial completion date: Mar 2029 --> Jul 2028 | Trial primary completion date: Mar 2027 --> Jul 2026
- || Columvi (glofitamab-gxbm) / Roche, Lunsumio (mosunetuzumab-axgb) / Roche
Trial completion date, Trial primary completion date, Combination therapy: CO43805: A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab or Glofitamab in Combination With CC-220 and CC-99282 in Participants With B-Cell Non-Hodgkin Lymphoma (clinicaltrials.gov) - Sep 26, 2024
P1, N=125, Recruiting, Sponsor: Hoffmann-La Roche
Trial completion date: Mar 2029 --> Jul 2028 | Trial primary completion date: Mar 2027 --> Jul 2026 Trial completion date: Jul 2028 --> Mar 2029 | Trial primary completion date: Jul 2026 --> Mar 2027
- ||| golcadomide (CC-99282) / BMS
Enrollment open, Combination therapy, Metastases: GOLSEEK-2: A Study to Evaluate the Efficacy and Safety of Golcadomide in Combination With Rituximab in Participants With Newly Diagnosed Advanced Stage Follicular Lymphoma (clinicaltrials.gov) - Aug 5, 2024
P2, N=90, Recruiting, Sponsor: Celgene
Trial completion date: Jul 2028 --> Mar 2029 | Trial primary completion date: Jul 2026 --> Mar 2027 Not yet recruiting --> Recruiting
- golcadomide (CC-99282) / BMS, Rituxan (rituximab) / Roche
Golcadomide (GOLCA; CC-99282), a Potential First-in-Class Oral CELMoD (LEVEL 3, GENERAL ASSEMBLY) - Jul 5, 2024 - Abstract #SOHO2024SOHO_256;
P1
GOLCA+R-CHOP had a high rate of durable CMRs irrespective of cell of origin; promising 12-month progression-free survival, including in HR patients; and a manageable safety profile without compromising curative treatment. This supports the randomized phase 3 GOLSEEK-1 trial of untreated HR LBCL.
- |||||| golcadomide (CC-99282) / BMS
Enrollment open: GOLSEEK-1: Study to Compare the Effectiveness and Safety of Golcadomide Plus R-CHOP vs Placebo Plus R-CHOP in Participants With Previously Untreated High-risk Large B-cell Lymphoma (clinicaltrials.gov) - Jun 12, 2024
P3, N=850, Recruiting, Sponsor: Celgene
This supports the randomized phase 3 GOLSEEK-1 trial of untreated HR LBCL. Not yet recruiting --> Recruiting
- || golcadomide (CC-99282) / BMS, Gazyva (obinutuzumab) / Roche, Biogen
Enrollment open: Phase 2 Trial of Obinutuzumab and CC-99282 for Patients With Previously Untreated High Tumor Burden Follicular Lymphoma (clinicaltrials.gov) - Jun 3, 2024
P2, N=36, Recruiting, Sponsor: M.D. Anderson Cancer Center
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- |||| golcadomide (CC-99282) / BMS
New P2 trial, Combination therapy, Metastases: GOLSEEK-2: A Study to Evaluate the Efficacy and Safety of Golcadomide in Combination With Rituximab in Participants With Newly Diagnosed Advanced Stage Follicular Lymphoma (clinicaltrials.gov) - May 22, 2024
P2, N=90, Not yet recruiting, Sponsor: Celgene
- Opdivo (nivolumab) / BMS, Rituxan (rituximab) / Roche
First-line treatment of follicular lymphoma (FL) with golcadamide, rituximab +/- nivolumab: An umbrella randomised phase 2 investigator-led study. (Hall A; Poster Bd #: 70b) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2427;
P2
This trial received IRB approval on 14 July 2023 (HREC/88597/Austin-2023). To date 15 pts have been randomised.
- |||||||||| golcadomide (CC-99282) / BMS
New P3 trial: GOLSEEK-1: Study to Compare the Effectiveness and Safety of Golcadomide Plus R-CHOP vs Placebo Plus R-CHOP in Participants With Previously Untreated High-risk Large B-cell Lymphoma (clinicaltrials.gov) - Apr 9, 2024
P3, N=850, Not yet recruiting, Sponsor: Celgene
- || ianalumab (VAY736) / MorphoSys, Novartis
Enrollment change, Trial completion date, Trial primary completion date, Combination therapy: Study of VAY736 as Single Agent and in Combination With Select Antineoplastic Agents in Patients With Non-Hodgkin Lymphoma (clinicaltrials.gov) - Mar 25, 2024
P1, N=40, Recruiting, Sponsor: Novartis Pharmaceuticals
To date 15 pts have been randomised. N=124 --> 40 | Trial completion date: Jun 2027 --> Oct 2026 | Trial primary completion date: Jun 2027 --> Oct 2026
- golcadomide (CC-99282) / BMS
Golcadomide (CC-99282) is a novel CELMoD (Section 27) - Mar 5, 2024 - Abstract #AACR2024AACR_5459;
Ven inhibited this immune activation, while Obi or Ibru maintained the immune activation. Collectively, these findings suggest that GOLCA, alone or in combination with targeted agents, may produce clinical benefit in CLL patients.
- | golcadomide (CC-99282) / BMS
New P2 trial, CAR T-Cell Therapy: Golcadomide Post-CAR T-cell in R/R Aggressive Large B-cell Lymphoma Patients With High Risk of Relapse (clinicaltrials.gov) - Feb 21, 2024
P2, N=65, Not yet recruiting, Sponsor: The Lymphoma Academic Research Organisation
- || golcadomide (CC-99282) / BMS, Rituxan (rituximab) / Roche
Enrollment open, CAR T-Cell Therapy: CC-99282 + Rituximab Early Post CART for Non-Hodgkin's Lymphoma (clinicaltrials.gov) - Jan 24, 2024
P1, N=18, Recruiting, Sponsor: Nathan Denlinger
Collectively, these findings suggest that GOLCA, alone or in combination with targeted agents, may produce clinical benefit in CLL patients. Not yet recruiting --> Recruiting
- || golcadomide (CC-99282) / BMS, Rituxan (rituximab) / Roche
New P1 trial, CAR T-Cell Therapy: CC-99282 + Rituximab Early Post CART for Non-Hodgkin's Lymphoma (clinicaltrials.gov) - Jan 17, 2024
P1, N=18, Not yet recruiting, Sponsor: Nathan Denlinger
- || Epkinly (epcoritamab-bysp) / Genmab, AbbVie
Trial completion date, Trial primary completion date, Adverse events, Combination therapy: EPCORE NHL-5: A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma (clinicaltrials.gov) - Jan 11, 2024
P2, N=394, Recruiting, Sponsor: AbbVie
Not yet recruiting --> Recruiting Trial completion date: May 2029 --> Nov 2032 | Trial primary completion date: May 2029 --> Nov 2032
- | iberdomide (CC-220) / BMS, golcadomide (CC-99282) / BMS
Phase classification, Combination therapy: CC-220-DLBCL-001: Study of Safety and Efficacy of Iberdomide (CC-220) and CC-99282 Combined With R-CHOP to Treat Lymphoma (clinicaltrials.gov) - Dec 28, 2023
P1, N=174, Recruiting, Sponsor: Celgene
Trial completion date: May 2029 --> Nov 2032 | Trial primary completion date: May 2029 --> Nov 2032 Phase classification: P1b --> P1
- ||| golcadomide (CC-99282) / BMS
Enrollment open: A Study to Assess the Safety, Tolerability, Efficacy, and Drug Levels of BMS-986369 in Participants With Relapsed or Refractory T-cell Lymphomas in Japan (clinicaltrials.gov) - Nov 29, 2023
P1/2, N=85, Recruiting, Sponsor: Bristol-Myers Squibb
Phase classification: P1b --> P1 Not yet recruiting --> Recruiting
- | Epkinly (epcoritamab-bysp) / Genmab, AbbVie
Phase classification, Adverse events, Combination therapy: EPCORE NHL-5: A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma (clinicaltrials.gov) - Nov 13, 2023
P2, N=394, Recruiting, Sponsor: AbbVie
Not yet recruiting --> Recruiting Phase classification: P1b/2 --> P2
- golcadomide (CC-99282) / BMS, Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche
Efficacy and Safety of Golcadomide, a Novel Cereblon E3 Ligase Modulator (CELMoD) Agent, Combined with Rituximab in a Phase 1/2 Open-Label Study of Patients with Relapsed/Refractory Non-Hodgkin Lymphoma (Halls G-H (San Diego Convention Center)) - Nov 3, 2023 - Abstract #ASH2023ASH_5939;
P1/2
Golcadomide oral therapy combined with rituximab showed promising efficacy in heavily pretreated patients with R/R DLBCL, including 1 durable response over 300 days. Golcadomide can be safely combined with rituximab, and the combination showed a safety profile similar to that previously reported for golcadomide monotherapy.
- golcadomide (CC-99282) / BMS, Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche
Golcadomide (GOLCA; CC-99282), a Novel CELMoD Agent, Plus R-CHOP in Patients (pts) with Previously Untreated Aggressive B-Cell Lymphoma (a-BCL): Safety and Efficacy Results from Phase 1b Dos... (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_5901;
P1b
Introduction Up to 40% of pts with diffuse large B-cell lymphoma (DLBCL) relapse after first-line chemo-immunotherapy with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP)...CC-220-DLBCL-001 (NCT04884035) is an ongoing open-label, multicenter, dose escalation and expansion trial to assess safety and preliminary efficacy of CELMoD agents + R-CHOP for untreated a-BCL...Efficacy results and substantial ctDNA decrease indicate robust clinical activity in frontline DLBCL, with a high CMR rate at EoT, particularly among patients treated at DL1. Study support Bristol Myers Squibb.
- golcadomide (CC-99282) / BMS, Opdivo (nivolumab) / Ono Pharma, BMS, Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche
Trial in Progress: Treatment of Newly-Diagnosed Follicular Lymphoma with Celmod BMS-986369, Rituximab +/- Nivolumab: An Umbrella Phase II Investigator-Initiated Study (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_4009;
P2
Survival probabilities will be reported using Kaplan-Meier analysis. Status: This trial received IRB approval on 14 July 2023 (HREC/88597/Austin-2023) at Austin Health, Heidelberg, Australia.
- golcadomide (CC-99282) / BMS, Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche
Pharmacodynamic Biomarkers and CtDNA Support the Mechanism of Action and Clinical Efficacy of Golcadomide (CC-99282) Combined with R-CHOP in Previously Untreated Aggressive B-Cell Lymphoma (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_2047;
P1b
Translational data demonstrate the potency of GOLCA and will support future frontline clinical trial designs in patients with untreated aggressive BCL. Study support : Celgene, a Bristol-Myers Squibb Company
- || golcadomide (CC-99282) / BMS, Gazyva (obinutuzumab) / Roche, Biogen
New P2 trial: Phase 2 Trial of Obinutuzumab and CC-99282 for Patients With Previously Untreated High Tumor Burden Follicular Lymphoma (clinicaltrials.gov) - Oct 29, 2023
P2, N=36, Not yet recruiting, Sponsor: M.D. Anderson Cancer Center
- || golcadomide (CC-99282) / BMS
Trial completion date, Trial primary completion date, Combination therapy: CC-99282-NHL-001: A Safety and Preliminary Efficacy Study of CC-99282, Alone and in Combination With Anti-lymphoma Agents in Participants With Relapsed or Refractory Non-Hodgkin Lymphomas (R/R NHL) (clinicaltrials.gov) - Sep 21, 2023
P1/2, N=348, Recruiting, Sponsor: Celgene
Study support : Celgene, a Bristol-Myers Squibb Company Trial completion date: Dec 2025 --> Apr 2027 | Trial primary completion date: Dec 2024 --> Apr 2026
- |||| golcadomide (CC-99282) / BMS
New P1/2 trial: A Study to Assess the Safety, Tolerability, Efficacy, and Drug Levels of BMS-986369 in Participants With Relapsed or Refractory T-cell Lymphomas in Japan (clinicaltrials.gov) - Sep 13, 2023
P1/2, N=85, Not yet recruiting, Sponsor: Bristol-Myers Squibb
- || golcadomide (CC-99282) / BMS, Opdivo (nivolumab) / BMS, Rituxan (rituximab) / Roche
Enrollment open: TOP-FLOR: Treatment Of Newly-diagnosed Follicular Lymphoma With CELMoD Golcadomide, Rituximab +/- Nivolumab. (clinicaltrials.gov) - Sep 1, 2023
P2, N=40, Recruiting, Sponsor: Olivia Newton-John Cancer Research Institute
Trial completion date: Dec 2025 --> Apr 2027 | Trial primary completion date: Dec 2024 --> Apr 2026 Not yet recruiting --> Recruiting
- || ianalumab (VAY736) / MorphoSys, Novartis
Trial primary completion date, Combination therapy: Study of VAY736 as Single Agent and in Combination With Select Antineoplastic Agents in Patients With Non-Hodgkin Lymphoma (clinicaltrials.gov) - Aug 29, 2023
P1, N=124, Recruiting, Sponsor: Novartis Pharmaceuticals
Not yet recruiting --> Recruiting Trial primary completion date: Sep 2025 --> Jun 2027
- || Columvi (glofitamab-gxbm) / Roche, Lunsumio (mosunetuzumab-axgb) / Roche
Trial completion date, Trial primary completion date, Combination therapy: CO43805: A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab or Glofitamab in Combination With CC-220 and CC-99282 in Participants With B-Cell Non-Hodgkin Lymphoma (clinicaltrials.gov) - Aug 8, 2023
P1, N=121, Recruiting, Sponsor: Hoffmann-La Roche
Trial primary completion date: Sep 2025 --> Jun 2027 Trial completion date: Apr 2027 --> Jul 2028 | Trial primary completion date: Apr 2025 --> Jul 2026
- | ianalumab (VAY736) / MorphoSys, Novartis
Trial completion date, Combination therapy: Study of VAY736 as Single Agent and in Combination With Select Antineoplastic Agents in Patients With Non-Hodgkin Lymphoma (clinicaltrials.gov) - Jul 3, 2023
P1, N=124, Recruiting, Sponsor: Novartis Pharmaceuticals
Trial completion date: Apr 2027 --> Jul 2028 | Trial primary completion date: Apr 2025 --> Jul 2026 Trial completion date: Sep 2025 --> Jun 2027
- ||| golcadomide (CC-99282) / BMS
Trial completion: A Study to Evaluate the Drug Exposure of Single Ascending Doses of BMS-986369 and the Effect of Food on the BMS-986369 in Healthy Participants (clinicaltrials.gov) - May 30, 2023
P1, N=68, Completed, Sponsor: Bristol-Myers Squibb
Trial completion date: Sep 2025 --> Jun 2027 Recruiting --> Completed
- golcadomide (BMS-986369) / BMS, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
CC-99282 plus R-CHOP in patients (pts) with previously untreated aggressive B-cell lymphoma (a- BCL): early safety and efficacy results from a phase 1b study () - May 4, 2023 - Abstract #ICML2023ICML_719;
- golcadomide (BMS-986369) / BMS, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Open-label phase 1/2 study of CC-99282, a cereblon E3 ligase modulator (CELMoD) agent (Room A) - May 4, 2023 - Abstract #ICML2023ICML_287;
- || ianalumab (VAY736) / MorphoSys, Novartis
Enrollment change, Combination therapy: Study of VAY736 as Single Agent and in Combination With Select Antineoplastic Agents in Patients With Non-Hodgkin Lymphoma (clinicaltrials.gov) - Apr 26, 2023
P1, N=124, Recruiting, Sponsor: Novartis Pharmaceuticals
Recruiting --> Completed N=86 --> 124
- || golcadomide (CC-99282) / BMS, Opdivo (nivolumab) / BMS, Rituxan (rituximab) / Roche
New P2 trial: TOP-FLOR: Treatment Of Newly-diagnosed Follicular Lymphoma With CELMoD Golcadomide, Rituximab +/- Nivolumab. (clinicaltrials.gov) - Mar 28, 2023
P2, N=40, Not yet recruiting, Sponsor: Olivia Newton-John Cancer Research Institute
- ||| Epkinly (epcoritamab-bysp) / Genmab, AbbVie
Enrollment change, Adverse events, Combination therapy: EPCORE NHL-5: A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma (clinicaltrials.gov) - Mar 24, 2023
P1b/2, N=394, Recruiting, Sponsor: AbbVie
N=86 --> 124 N=132 --> 394
- ||| Breyanzi (lisocabtagene maraleucel) / BMS
Trial completion: PLATFORM: A Safety and Efficacy Trial of JCAR017 Combinations in Subjects With Relapsed/Refractory B-cell Malignancies (clinicaltrials.gov) - Mar 24, 2023
P1/2, N=62, Completed, Sponsor: Celgene
N=132 --> 394 Active, not recruiting --> Completed
- || golcadomide (CC-99282) / BMS
Enrollment closed, Combination therapy: A Safety and Preliminary Efficacy Study of CC-99282 in Combination With Obinutuzumab in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (clinicaltrials.gov) - Mar 14, 2023
P1b, N=50, Active, not recruiting, Sponsor: Celgene
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- ||| golcadomide (BMS-986369) / BMS, Yescarta (axicabtagene ciloleucel) / Gilead
Hahahaha good point. We dont have mosu or axi cel here for FL. I would probably consider CELESTIMO or CC99282 from BMS... (Twitter) - Mar 8, 2023
- || golcadomide (CC-99282) / BMS
Trial completion: A Study to Evaluate the Metabolism and Excretion of BMS-986369 in Healthy Male Participants (clinicaltrials.gov) - Feb 17, 2023
P1, N=8, Completed, Sponsor: Bristol-Myers Squibb
Recruiting --> Active, not recruiting Recruiting --> Completed
- || iberdomide (CC-220) / BMS, golcadomide (CC-99282) / BMS
Enrollment change, Combination therapy: CC-220-DLBCL-001: Study of Safety and Efficacy of Iberdomide (CC-220) and CC-99282 Combined With R-CHOP to Treat Lymphoma (clinicaltrials.gov) - Feb 15, 2023
P1b, N=174, Recruiting, Sponsor: Celgene
Recruiting --> Completed N=116 --> 174
- ||| golcadomide (CC-99282) / BMS
Phase classification, Enrollment change, Combination therapy: CC-99282-NHL-001: A Safety and Preliminary Efficacy Study of CC-99282, Alone and in Combination With Anti-lymphoma Agents in Participants With Relapsed or Refractory Non-Hodgkin Lymphomas (R/R NHL) (clinicaltrials.gov) - Jan 18, 2023
P1/2, N=387, Recruiting, Sponsor: Celgene
N=116 --> 174 Phase classification: P1 --> P1/2 | N=210 --> 387
- || Breyanzi (lisocabtagene maraleucel) / BMS
Trial completion date, Trial primary completion date: PLATFORM: A Safety and Efficacy Trial of JCAR017 Combinations in Subjects With Relapsed/Refractory B-cell Malignancies (clinicaltrials.gov) - Jan 17, 2023
P1/2, N=62, Active, not recruiting, Sponsor: Celgene
Phase classification: P1 --> P1/2 | N=210 --> 387 Trial completion date: Jul 2025 --> Jan 2023 | Trial primary completion date: Jul 2025 --> Jan 2023
- || golcadomide (CC-99282) / BMS
Enrollment open: A Study to Evaluate the Metabolism and Excretion of BMS-986369 in Healthy Male Participants (clinicaltrials.gov) - Nov 10, 2022
P1, N=8, Recruiting, Sponsor: Bristol-Myers Squibb
Trial completion date: Jul 2025 --> Jan 2023 | Trial primary completion date: Jul 2025 --> Jan 2023 Not yet recruiting --> Recruiting
- iberdomide (CC-220) / BMS, golcadomide (CC-99282) / BMS, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Phase 1b Trial of Cereblon-Modulating Agents Iberdomide and CC-99282 Plus R-CHOP in Previously Untreated Aggressive B-Cell Lymphoma (Hall D (Ernest N. Morial Convention Center)) - Nov 4, 2022 - Abstract #ASH2022ASH_6080;
P1b
The standard of care for patients (pts) with DLBCL is chemo-immunotherapy with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP); however, up to 45%–50% of pts relapse after first-line (1L) R-CHOP...Lenalidomide (LEN) modulates cereblon E3 ligase, leading to antitumor effects and degradation of target proteins...The study opened on September 15, 2021 and is currently recruiting. Study support: This study is supported by Bristol Myers Squibb.
- golcadomide (CC-99282) / BMS
Elucidating the Molecular Mechanisms of Action of CC-99282, a Novel Cereblon (CRBN) E3 Ligase Modulator (CELMoD) Agent, Via Genome-Wide CRISPR Screen in a Preclinical Model of Non-Hodgkin Lymphoma (NHL) (Hall D (Ernest N. Morial Convention Center)) - Nov 4, 2022 - Abstract #ASH2022ASH_5799;
P1
Compared with immunomodulatory agents such as lenalidomide that also degrade Ikaros/Aiolos, CC-99282 demonstrates a faster, deeper, and more sustained degradation of these transcription factors...Venetoclax (VEN), a BCL2 inhibitor approved for the treatment of pts with chronic lymphocytic leukemia and acute myeloid leukemia, was tested in aggressive NHL cell lines alone or in combination with CC-99282...Lastly, combination of CC-99282 with CDK4/6 inhibitors palbociclib/abemaciclib, which prevent cell-cycle progression, showed strong synergistic effects in NHL cell lines without RB1 loss or CCND3 mutations...This study revealed genetic alterations that may be associated with clinical response to CC-99282 in pts with NHL. These in vitro data highlight potential biomarkers that could facilitate patient stratification in future clinical trials and provide rationale for combination therapies that may improve clinical outcomes for pts with R/R NHL.
- golcadomide (CC-99282) / BMS
Association of Immune Dynamics and Treatment Outcome in Patients (pts) with Relapsed/Refractory Non-Hodgkin Lymphoma (R/R NHL) Treated with the Novel Cereblon (CRBN) E3 Ligase Modulator (CELMoD) Agent CC‑99282 (Hall D (Ernest N. Morial Convention Center)) - Nov 4, 2022 - Abstract #ASH2022ASH_4281;
P1
CC-99282 (BMS-986369) is a novel CELMoD® agent that has enhanced antiproliferative, apoptotic, and immune-stimulatory effects compared with other immunomodulatory agents in various preclinical NHL models...Responder subsets were identified based on effects on Tregs and immune activation; however, all cases led to durable responses. Further study and validation of these data could provide rationale for pt selection and combination strategies.
- ||| golcadomide (CC-99282) / BMS
Enrollment open, Trial completion date, Trial initiation date, Trial primary completion date: A Study to Evaluate the Drug Exposure of Single Ascending Doses of BMS-986369 and the Effect of Food on the BMS-986369 in Healthy Participants (clinicaltrials.gov) - Oct 7, 2022
P1, N=68, Recruiting, Sponsor: Bristol-Myers Squibb
Further study and validation of these data could provide rationale for pt selection and combination strategies. Not yet recruiting --> Recruiting | Trial completion date: Nov 2022 --> Mar 2023 | Initiation date: May 2022 --> Sep 2022 | Trial primary completion date: Nov 2022 --> Mar 2023
- || golcadomide (CC-99282) / BMS
New P1 trial: A Study to Evaluate the Metabolism and Excretion of BMS-986369 in Healthy Male Participants (clinicaltrials.gov) - Oct 5, 2022
P1, N=8, Not yet recruiting, Sponsor: Bristol-Myers Squibb
- ||| Breyanzi (lisocabtagene maraleucel) / BMS
Enrollment closed, Enrollment change: PLATFORM: A Safety and Efficacy Trial of JCAR017 Combinations in Subjects With Relapsed/Refractory B-cell Malignancies (clinicaltrials.gov) - Oct 3, 2022
P1/2, N=62, Active, not recruiting, Sponsor: Celgene
Not yet recruiting --> Recruiting | Trial completion date: Nov 2022 --> Mar 2023 | Initiation date: May 2022 --> Sep 2022 | Trial primary completion date: Nov 2022 --> Mar 2023 Recruiting --> Active, not recruiting | N=108 --> 62
- || CC-99282 / BMS
Clinical, P1 data, Clinical Trial,Phase I, Journal: ABCL-412 Clinical Activity of CC-99282, a Novel, Oral, Small Molecule Cereblon E3 Ligase Modulator (CELMoD) Agent, in Patients With Relapsed/Refractory Non-Hodgkin Lymphoma (R/R NHL) -Results From CC-99282-NHL-001 (NCT03930953) a First-in-Human, Phase 1, Open-Label, Multicenter Study. (Pubmed Central) - Sep 29, 2022
P1
Pharmacokinetic/pharmacodynamic data were consistent with robust/rapid CC-99282-mediated antitumor activity. This BMS-funded study is enrolling patients.