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  • ||||||||||  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.
  • ||||||||||  CARCIK-CD19 / CoImmune
    Enrollment open:  Allogeneic CARCIK-CD19 in Adults/Pediatric B-cell NHL or Chronic Lymphocytic Leukemia (clinicaltrials.gov) -  May 3, 2024   
    P1/2,  N=29, Recruiting, 
    CAR T cells-mediatedmyeloid activation is associated with pathways of immune dysregulation that may dampen CAR T cellexpansion and antagonize the effects of the therapy. Not yet recruiting --> Recruiting
  • ||||||||||  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
    Trial completion, Trial completion date:  Transposon-manipulated Allogeneic CARCIK-CD19 Cells in Pediatric and Adult Patients With r/r ALL Post HSCT (clinicaltrials.gov) -  May 6, 2023   
    P1/2,  N=21, Completed, 
    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 Active, not recruiting --> Completed | Trial completion date: Mar 2022 --> Dec 2022
  • ||||||||||  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
  • ||||||||||  CARCIK-CD19 / CoImmune
    Enrollment closed, Trial completion date, Trial primary completion date:  Transposon-manipulated Allogeneic CARCIK-CD19 Cells in Pediatric and Adult Patients With r/r ALL Post HSCT (clinicaltrials.gov) -  Feb 4, 2022   
    P1/2,  N=21, Active, not recruiting, 
    Trial completion date: Mar 2022 --> Mar 2024 | Trial primary completion date: Mar 2022 --> Mar 2024 Recruiting --> Active, not recruiting | Trial completion date: Apr 2021 --> Mar 2022 | Trial primary completion date: Dec 2020 --> Mar 2021
  • ||||||||||  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
  • ||||||||||  rocapuldencel-T (CMN-001) / CoImmune, SCM Lifescience
    Trial termination, Trial primary completion date, Metastases:  ADAPT: Phase 3 Trial of Autologous Dendritic Cell Immunotherapy Plus Standard Treatment of Advanced Renal Cell Carcinoma (clinicaltrials.gov) -  Jun 14, 2018   
    P3,  N=462, Terminated, 
    Trial completion date: Dec 2017 --> May 2018 | Active, not recruiting --> Terminated | Trial primary completion date: Dec 2017 --> May 2018; Lack of efficacy Active, not recruiting --> Terminated | Trial primary completion date: Dec 2017 --> Apr 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
    Trial termination, IO biomarker, Surgery:  Vaccine Therapy Before Surgery in Treating Patients With Localized Kidney Cancer (clinicaltrials.gov) -  Jan 5, 2018   
    P=N/A,  N=4, Terminated, 
    Trial primary completion date: Sep 2017 --> Mar 2017 Withdrawn --> Terminated; sponsor having financial difficulties
  • ||||||||||  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, IO biomarker, Surgery:  Vaccine Therapy Before Surgery in Treating Patients With Localized Kidney Cancer (clinicaltrials.gov) -  Apr 20, 2017   
    P=N/A,  N=10, Recruiting, 
    Phase classification: P1/2 --> P1 Trial primary completion date: Apr 2017 --> Jul 2017
  • ||||||||||  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
  • ||||||||||  AGS-004 / CoImmune
    Trial completion, Enrollment change, Trial primary completion date:  A Phase I Study to Evaluate the Immunologic Response and Virologic Impact of AGS-004 (clinicaltrials.gov) -  Oct 28, 2016   
    P1/2,  N=6, Completed, 
    Trial primary completion date: Dec 2016 --> Dec 2017 Recruiting --> Completed | N=12 --> 6 | Trial primary completion date: Dec 2016 --> May 2016