- |||||||||| CARCIK-CD19 / CoImmune
Efficacy, safety, and biological properties of Sleeping Beauty-engineered CAR T cells in patients with B-cell acute lymphoblastic leukemia (Room 291-292) - Apr 10, 2025 - Abstract #ASGCT2025ASGCT_516; To offer a more streamlined and cost-effective approach to achieve stable gene transfer, we utilized Sleeping Beauty transposon to engineer donor-derived anti-CD19 CAR T cells (CARCIK-CD19) for B-ALL patients relapsed after allogeneic hematopoietic stem cell transplantation (alloHSCT)...In conclusion, CAR T cells-mediated myeloid activation is associated with pathways of immune dysregulation that may dampen CAR T cell expansion and antagonize the effects of the therapy. Disease Focus of Abstract:Leukemia
- |||||||||| CARCIK-CD19 / CoImmune
Cord Blood-Derived Carcik Cells As Off-the-Shelf Non-Viral Cell Therapy for Hematological Malignancies (Halls G-H (San Diego Convention Center)) - Nov 6, 2024 - Abstract #ASH2024ASH_3741; Our work has proven feasibility and safety of using Peripheral Blood (PB) healthy donor cells to generate CARCIK-CD19 cells1...Metabolic and transcriptomic analyses revealed that CB-CARCIK cells exhibit a lower glycolytic score and a higher memory score compared to those derived from peripheral blood (PB), indicating advantageous CAR T cell characteristics. Furthermore, we established the scalability of a GMP-grade manufacturing process for deriving CARCIK cells from CB, enabling the production of readily available, banked, third-party CARCIK cells for treating hematological malignancies.
- |||||||||| rocapuldencel-T (CMN-001) / CoImmune, SCM Lifescience
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: Dendritic Cell Immunotherapy Plus Standard Treatment of Advanced Renal Cell Carcinoma (clinicaltrials.gov) - Oct 2, 2023 P2b, N=16, Terminated, Furthermore, these data support the hypothesis that transcriptomic interrogation can infer pathways relevant to the communication between CAR T cells and the TME. N=120 --> 16 | Trial completion date: Mar 2024 --> Sep 2023 | Recruiting --> Terminated | Trial primary completion date: Mar 2024 --> Sep 2023; Strategic corporate decision
- |||||||||| CARCIK-CD19 / CoImmune
SLEEPING BEAUTY PLATFORM FOR ENGINEERING CAR-CIK CELLS TOWARD A MULTI-TARGETING STRATEGY IN B-ALL (Poster area) - May 12, 2023 - Abstract #EHA2023EHA_1669; The design of the phase 2b study combines CMN-001 with first-line checkpoint inhibition therapy and second line lenvatinib/everolimus in poor-risk mRCC subjects. To overcome viral method's limitations in T cell engineering, our group developed an anti-CD19 CAR engineered Cytokine Induced Killer (CIK) cells through a Sleeping
- |||||||||| CARCIK-CD19 / CoImmune
Phase I/II Trials with Sleeping Beauty Engineered CAR T Cells of Donor Origin for B-cell Acute Lymphoblastic Leukemia (Board No. 1206) - Apr 21, 2023 - Abstract #ASGCT2023ASGCT_1562; P1/2 After lymphodepletion with Fludarabine and Cyclophosphamide, patients received a single infusion...Although 10 out of 27 had experienced GvHD after the previous allo-SCT, GvHD never occurred after treatment with CARCIK-CD19...No signs of genotoxicity by transposon insertions could be observed. SB-engineered CAR T cells of donor origin showed an excellent safety profile with anti-leukemia activity in heavily pretreated patients with B-ALL.
- |||||||||| Yescarta (axicabtagene ciloleucel) / Gilead
Flow Cytometry Detection of CAR-T Cells (Poster Area) - Jan 24, 2023 - Abstract #EHAEBMTCART2023EHA_EBMT_CART_105; P1/2 The CD19-his and CD19-bio gave similar results, but CD19-his is more cost-effective compared to CD19-bio. CAR detection with CD19-his was validated with parallel real time PCR data.
- |||||||||| rocapuldencel-T (CMN-001) / CoImmune, SCM Lifescience
Trial completion date, Trial primary completion date: Dendritic Cell Immunotherapy Plus Standard Treatment of Advanced Renal Cell Carcinoma (clinicaltrials.gov) - Jul 29, 2022 P2b, N=120, Recruiting, Conclusions In this phase I/II dose-finding study, SB-engineered CAR T cells demonstrated an excellent safety profile with anti-leukemia activity in heavily pretreated patients with B-ALL relapsed after HSCT. Trial completion date: Mar 2022 --> Mar 2024 | Trial primary completion date: Mar 2022 --> Mar 2024
- |||||||||| rocapuldencel-T (CMN-001) / CoImmune, SCM Lifescience, Sutent (sunitinib) / Pfizer
Clinical, P3 data, Journal, Combination therapy, IO biomarker: Results of the ADAPT phase 3 study of Rocapuldencel-T in combination with sunitinib as first-line therapy in patients with metastatic renal cell carcinoma. (Pubmed Central) - Feb 5, 2021 Rocapuldencel-T did not improve OS in patients treated with combination therapy, although the immune response correlated with OS. Moreover, we identified two potential survival-predictive biomarkers for patients receiving DC based immuno-therapy, DC vaccine produced IL-12 and higher numbers of T regulatory cells present in the peripheral blood of mRCC patients.
- |||||||||| rocapuldencel-T (CMN-001) / CoImmune, SCM Lifescience
Enrollment open, Trial initiation date: Dendritic Cell Immunotherapy Plus Standard Treatment of Advanced Renal Cell Carcinoma (clinicaltrials.gov) - Sep 24, 2020 P2b, N=120, Recruiting, More efficacious antiviral immune interventions, perhaps paired with more effective latency reversal, must be developed to clear persistent HIV infection. Not yet recruiting --> Recruiting | Initiation date: Mar 2020 --> Jul 2020
- |||||||||| rocapuldencel-T (AGS-003) / Argos Therapeutics, IMA-901 / Immatics
Journal: Immunotherapy of renal cell cancer (Pubmed Central) - Oct 4, 2019 The newest checkpoint agents, vaccination and pegylated interleukin-2 are also presented. The most promising clinical trials (CheckMate-025, AGS-003, IMA 901) and the on-going first line phase III trials are shown in metastatic clear cell renal carcinoma.
- |||||||||| Zolinza (vorinostat) / Merck (MSD), AGS-004 / CoImmune
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: VORVAX: Pilot Trial of the Effect of Vorinostat and AGS-004 on Persistent HIV-1 Infection (clinicaltrials.gov) - Aug 2, 2018 P1, N=6, Terminated, AGS-004 may be a useful tool to augment immune responses in the setting of latency reversal and eradication strategies. N=12 --> 6 | Trial completion date: Feb 2021 --> Jul 2018 | Recruiting --> Terminated | Trial primary completion date: Feb 2021 --> Jul 2018; Manufacturing of the AGS-004 HIV vaccine by Argos could no longer be provided.
- |||||||||| rocapuldencel-T (CMN-001) / CoImmune, SCM Lifescience
Trial completion date, Trial termination, Trial primary completion date: A Rollover Protocol for Subjects Previously Treated With AGS-003 (clinicaltrials.gov) - Jun 27, 2018 P2, N=2, Terminated, N=12 --> 6 | Trial completion date: Feb 2021 --> Jul 2018 | Recruiting --> Terminated | Trial primary completion date: Feb 2021 --> Jul 2018; Manufacturing of the AGS-004 HIV vaccine by Argos could no longer be provided. Trial completion date: Dec 2017 --> May 2018 | Active, not recruiting --> Terminated | Trial primary completion date: Dec 2017 --> May 2018; Lack of efficacy
- |||||||||| Zolinza (vorinostat) / Merck (MSD), AGS-004 / CoImmune
Trial completion date, Trial primary completion date: VORVAX: Pilot Trial of the Effect of Vorinostat and AGS-004 on Persistent HIV-1 Infection (clinicaltrials.gov) - Apr 19, 2018 P1, N=12, Recruiting, Active, not recruiting --> Terminated | Trial primary completion date: Dec 2017 --> Apr 2018; Lack of efficacy Trial completion date: Dec 2019 --> Feb 2021 | Trial primary completion date: Mar 2018 --> Feb 2021
- |||||||||| rocapuldencel-T (CMN-001) / CoImmune, SCM Lifescience
Trial primary completion date, IO biomarker, Surgery: Vaccine Therapy Before Surgery in Treating Patients With Localized Kidney Cancer (clinicaltrials.gov) - Jan 31, 2018 P=N/A, N=4, Terminated, Trial completion date: Dec 2019 --> Feb 2021 | Trial primary completion date: Mar 2018 --> Feb 2021 Trial primary completion date: Sep 2017 --> Mar 2017
- |||||||||| rocapuldencel-T (CMN-001) / CoImmune, SCM Lifescience
Enrollment change, Trial withdrawal, Trial primary completion date, Surgery: Gemcitabine Hydrochloride, Cisplatin, and AGS-003-BLD in Treating Patients With Muscle-Invasive Bladder Cancer Undergoing Surgery (clinicaltrials.gov) - Nov 17, 2017 P=N/A, N=0, Withdrawn, Withdrawn --> Terminated; sponsor having financial difficulties N=20 --> 0 | Not yet recruiting --> Withdrawn | Trial primary completion date: Nov 2021 --> Sep 2017
- |||||||||| rocapuldencel-T (CMN-001) / CoImmune, SCM Lifescience
Enrollment change, Trial withdrawal, Trial primary completion date, IO biomarker, Surgery: Vaccine Therapy Before Surgery in Treating Patients With Localized Kidney Cancer (clinicaltrials.gov) - Sep 18, 2017 P=N/A, N=0, Withdrawn, N=20 --> 0 | Not yet recruiting --> Withdrawn | Trial primary completion date: Nov 2021 --> Sep 2017 N=10 --> 0 | Recruiting --> Withdrawn | Trial primary completion date: Jul 2018 --> Sep 2017
- |||||||||| rocapuldencel-T (CMN-001) / CoImmune, SCM Lifescience
Trial primary completion date, IO biomarker, Surgery: Vaccine Therapy Before Surgery in Treating Patients With Localized Kidney Cancer (clinicaltrials.gov) - Aug 17, 2017 P=N/A, N=10, Recruiting, N=10 --> 0 | Recruiting --> Withdrawn | Trial primary completion date: Jul 2018 --> Sep 2017 Trial primary completion date: Jul 2017 --> Jul 2018
- |||||||||| rocapuldencel-T (CMN-001) / CoImmune, SCM Lifescience
Trial primary completion date: A Rollover Protocol for Subjects Previously Treated With AGS-003 (clinicaltrials.gov) - Jan 24, 2017 P2, N=2, Active, not recruiting, Trial primary completion date: Apr 2017 --> Jul 2017 Trial primary completion date: Dec 2016 --> Dec 2017
|