Study of GC012F, CAR-T Therapy Targeting CD19 and BCMA in Chinese Participants With Relapsed or R… (NCT07250269) | Clinical Trial Compass
RecruitingPhase 1
Study of GC012F, CAR-T Therapy Targeting CD19 and BCMA in Chinese Participants With Relapsed or Refractory AL Amyloidosis
China9 participantsStarted 2025-10-29
Plain-language summary
This is a Phase 1b open-label, multicenter, non-randomized study of GC012F, a CD19/BCMA dual CAR T cell therapy, in adult participants with relapsed/refractory AL amyloidosis.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Confirmed histopathological diagnosis of AL amyloidosis
✓. One or more organs currently or historically impacted by AL amyloidosis according to consensus guidelines
✓. Relapsed disease or refractory disease defined as a need for additional therapy after at least 1 line of anti-plasma cell-directed therapy.
✓. ECOG performance status of 0 to 1
✓. Must be able and willing to adhere to the study visit schedule and other protocol requirements
✓. Women of child-bearing potential (WCBP) must have a negative serum pregnancy test prior to treatment. All sexually active WCBP and all sexually active male subjects must agree to use effective methods of birth control throughout the study.
Exclusion criteria
✕. Have any other form of amyloidosis other than AL amyloidosis
✕. Mayo Stage IIIb AL amyloidosis
✕. Oxygen saturation \< 95% on room air
✕. Systolic blood pressure \<100mmHg
✕. Cardiac exclusion criteria:
✕. Mayo Stage IIIb AL amyloidosis (Wechalekar, 2013)
What they're measuring
1
Number of Participants With incidence and severity of Treatment-emergent Adverse Events
Timeframe: Through study completion, an average of 2 years
2
Proportion of Participants Experiencing a Complete Response
Timeframe: Through study completion, an average of 2 years