NCT04935580: Phase 1/2: Study of FasT CAR-T GC012F Injection in High Risk TE NDMM Patients
Updated: Jun 15, 2022
NCT04935580: Phase 1/2: Study of FasT CAR-T GC012F Injection in High Risk TE NDMM Patients
Study of FasT CAR-T GC012F Injection in High Risk TE NDMM Patients
This is a single arm, open label, single-center prospective study to evaluate the safety and efficacy of GC012F as frontline therapy for transplant eligible multiple myeloma(MM) patients with high-risk profile. Patients enrolled will be newly diagnosed treatment naïve patients who are eligible for transplant.
Sponsor
Shanghai Changzheng Hospital
Collaborator
ClinicalTrials.gov Identifier: NCT04935580
Official Title: Frontline Therapy of GC012F Injection in Transplant Eligible Newly Diagnosed Multiple Myeloma Patients With High-Risk Profile
First Posted : June 23, 2021
Click here to see details on ClinicalTrials.gov
Biological: GC012F injection
GC012F injection is an autologous dual CAR-T targeted BCMA and CD19. A single infusion of CAR-T cells will be administered intravenously.
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).
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
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