- Recruiting
NCT04236011: Phase 1: BCMA and CD19 Targeted Fast Dual CAR-T for BCMA+ Refractory/Relapsed Myeloma
Updated: Jun 15, 2022
NCT04236011: Phase 1: BCMA and CD19 Targeted Fast Dual CAR-T for BCMA+ Refractory/Relapsed Multiple Myeloma
BCMA and CD19 Targeted Fast Dual CAR-T for BCMA+ Refractory/Relapsed Multiple Myeloma
This is a single arm, open-label, multi-center prospective study to determine the safety and efficacy of GC012F CAR-T cells in patients diagnosed with BCMA+ refractory/relapsed multiple myeloma (r/r MM).
Sponsor
Shanghai Changzheng Hospital
Collaborator
ClinicalTrials.gov Identifier: NCT04236011
Official Title: Exploratory Study to Evaluate Efficacy and Safety of GC012F Injection in BCMA+ Refractory/Relapsed Multiple Myeloma
First Posted: January 22, 2020
Click here to see details on ClinicalTrials.gov
Biological: GC012F injection
Autologous Bispecific BCMA/CD19-targeted CAR-T Cells GC012F (Code C175471)
Autologous Anti-BCMA/CD19 Dual CAR T Cells GC012F
Autologous Bispecific BCMA/CD19-targeted CAR-T Cells GC012F
Autologous GC012F CAR-T Cells
GC 012F
GC-012F
GC012F
EHA2022 Oral Presentation
EHA 2022 - HYBRID - JUNE 9-17 - VIENNA
UPDATED RESULTS OF A MULTICENTER FIRST-IN-HUMAN STUDY OF BCMA/CD19 DUAL-TARGETING FAST CAR-T GC012F FOR PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA (RRMM)
Meeting: 2022 ASCO Annual Meeting - Session Type: Oral Abstract Session - Session Title: Hematologic Malignancies—Plasma Cell Dyscrasia - Track: Hematologic Malignancies - Sub Track: Hematologic Malignancies - Clinical Trial Registration Number: NCT04236011; NCT04182581
Updated results of a multicenter first-in-human study of BCMA/CD19 dual-targeting fast CAR-T GC012F for patients with relapsed/refractory multiple myeloma (RRMM).
Click here to read abstract details
ABSTRACTS & PRESENTATIONS
2022 ASCO ANNUAL MEETING - June 3-7, 2022 - McCormick Place, Chicago, IL - Hybrid Meeting
2022 ASCO Annual Meeting - Oral Abstract Session
Gracell Biotechnologies
https://www.gracellbio.com/technology
https://www.gracellbio.com/fastcar
https://www.gracellbio.com/pipeline/index.html
Gracell Biotechnologies Granted FDA Orphan Drug Designation for FasTCAR-enabled BCMA/CD19 Dual-targeting CAR-T Cell Therapy Candidate GC012F for the Treatment of Multiple Myeloma
SUZHOU and SHANGHAI, China, and PALO ALTO, Calif., Nov. 19, 2021 /PRNewswire/ -- Gracell Biotechnologies Inc. (NASDAQ: GRCL) ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for GC012F, Gracell's FasTCAR-enabled BCMA/CD19 dual-targeting CAR-T cell therapy for the treatment of multiple myeloma.
ASCO - 2021 - Long-term follow-up results of a multicenter first-in-human study of the dual BCMA/CD19 Targeted FasT CAR-T GC012F for patients with relapsed/refractory multiple myeloma.
Conclusions: BCMA-CD19 dual FasT CAR-T GC012F showed early, deep and durable responses with a high ORR (94.7% - VGPR and better) including a high MRD- sCR rate (DL3=100%, n=9) in high risk RRMM pts including those refractory to anti-CD38, PI and IMIDs with a favorable safety profile consistent with previous findings. BCMA-CD19 dual FasT CAR-T GC012F may present a new treatment approach for patients with RRMM including those with high-risk features refractory to standard of care
EHA 2021 - E-poster - 06/09/21: LONG-TERM FOLLOW-UP RESULTS OF A MULTICENTER FIRST-IN-HUMAN STUDY OF THE DUAL BCMA/CD19 TARGETED FAST CAR-T GC012F FOR PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA
Conclusion: BCMA-CD19 dual FasT CAR-T GC012F showed early, deep and durable responses with a high ORR (94.7%; VGPR or better) including a high MRD negative sCR rate (DL3=100%, n=9) in high risk RRMM pts including those refractory to anti-CD38, PI and IMIDs with a favorable safety profile consistent with previous findings. BCMA-CD19 dual FasT CAR-T GC012F may present a new treatment approach for patients with RRMM including those with high-risk features refractory to standard of care.
Gracell Biotechnologies to Present Updated Results of GC012F FasTCAR-enabled BCMA/CD19 Dual-targeting CAR-T Cell Therapy for Relapsed/Refractory Multiple Myeloma at ASCO 2021 and EHA 2021
SUZHOU, China and PALO ALTO, Calif., May 19, 2021 /PRNewswire/ -- Gracell Biotechnologies Inc. (NASDAQ: GRCL) ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, is presenting updated results of their first-in-human multicenter study of GC012F for the treatment of relapsed and/or refractory multiple myeloma, a FasTCAR-enabled BCMA/CD19 dual-targeting CAR-T cell therapy currently in development for the treatment of multiple myeloma, at the 2021 American Society of Clinical Oncology ("ASCO") Annual Meeting and the European Hematology Association 2021 ("EHA2021") Congress.
Location
China, Shanghai
A Study of BCMA/CD19 Dual-Target CAR-T Cell Immunotherapy for Relapsed Myeloma
NCT04182581: Phase 1: A Study of BCMA/CD19 Dual-Target CAR-T Cell Immunotherapy for Relapsed Myeloma