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NCT07250269

Study of GC012F, CAR-T Therapy Targeting CD19 and BCMA in Chinese Participants With Relapsed or Refractory AL Amyloidosis

StatusRecruiting
PhasePhase 1
Primary completion (estimated)
Track this trial

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Record History

All 6 versions: 6 with changes below. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria shortened, about 4 words
    • Enrollment increased: 9 → 12 participants
    • Site details revised at 2 of 9 sites
  2. Primary endpoint(s) modified
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints: 2 to 3
    v5
  3. Site details revised at 1 of 9 sitesv4
  4. Site details revised at 2 of 9 sitesv3
  5. Study sites: 8 to 9v2
  6. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Number of Participants With incidence and severity of Treatment-emergent Adverse Events
Timeframe: Through study completion, an average of 2 years
Number of participants with dose-limiting toxicities during dose escalation phase
Timeframe: Through study completion, an average of 2 years

Secondary (3)

Levels of GC012F in blood over time in participants with AL amyloidosis
Percentage of participants who achieve a hematologic response based on modified response criteria (CR, VGPR, or low dFLC PR)
Percentage of participants who achieve a complete response based on hematologic response criteria for AL amyloidosis

Arms and interventions

GC012FExperimental

GC012F Injection

Drugs: GC012F Injection

Sites

9 sites in 1 country