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Clinical Trial Summary

This trial is a phase 1b/2, open-label, multicenter study of GC012F, a CD19/BCMA dual CART-cell therapy, in adult subjects with relapsed/refractory Multiple Myeloma.


Clinical Trial Description

For Phase Ib It aims to evaluate the safety, tolerability, pharmacokinetic characteristics, pharmacodynamic effect, immunogenicity in subjects with relapsed/ refractory Multiple Myeloma, and determine the recommended Phase 2 dose of GC012F. For Phase 2, it aims to evaluate the efficacy, to further characterize the safety of GC012F, pharmacodynamic effect, and immunogenicity, changes from baseline for subject-reported health-related quality of life, overall health status in subjects with relapsed/ refractory Multiple Myeloma. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05850234
Study type Interventional
Source Gracell Biopharmaceuticals, Inc.
Contact Grace Hong, MD
Phone 713-231-8670
Email grace.hong@gracellbio.com
Status Recruiting
Phase Phase 1/Phase 2
Start date July 20, 2023
Completion date June 2026

See also
  Status Clinical Trial Phase
Withdrawn NCT05461209 - A Study of Comparing Talquetamab to Belantamab Mafodotin in Participants With Relapsed/Refractory Multiple Myeloma Phase 3
Recruiting NCT05338775 - A Study of Talquetamab and Teclistamab Each in Combination With a Programmed Cell Death Receptor-1 (PD-1) Inhibitor for the Treatment of Participants With Relapsed or Refractory Multiple Myeloma Phase 1
Terminated NCT03445663 - Study Evaluating AMG 424 in Subjects With Multiple Myeloma Phase 1