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NCT04935580: Phase 1/2: Study of FasT CAR-T GC012F Injection in High Risk TE NDMM Patients

Updated: Jun 15


NCT04935580: Phase 1/2: Study of FasT CAR-T GC012F Injection in High Risk TE NDMM Patients


fast cart gc012f

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

Gracell Biotechnology Shanghai Co., Ltd.

 

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.

 

GC-012F


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

 

NCT04236011: Phase 1: BCMA and CD19 Targeted Fast Dual CAR-T for BCMA+ Refractory/Relapsed Myeloma

 

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)


Click here for details

 

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

Click here for details

 

Gracell Biotechnologies


https://www.gracellbio.com

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.


Click here for details

 

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


Click here for details

 

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.


Click here for the details

 

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.


Click here for details

 

Location

China, Shanghai





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