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OncoMatch/Clinical Trials/NCT07250269

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

Is NCT07250269 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1 trial studies GC012F for relapsed/refractory al amyloidosis.

Phase 1RecruitingGracell Biotechnologies (Shanghai) Co., Ltd.NCT07250269Data as of Sep 2026Location: China

Treatment: GC012FThis 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.

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Extracted eligibility criteria

Treatments studied

Other

GC012F

Cancer type

Multiple Myeloma

Disease stage

Excluded: Stage MAYO STAGE IIIB AL AMYLOIDOSIS

Mayo Stage IIIb AL amyloidosis

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

Must have received: anti-plasma cell-directed therapy

Relapsed disease or refractory disease defined as a need for additional therapy after at least 1 line of anti-plasma cell-directed therapy.

Cannot have received: CAR-T cell therapy

Prior CAR T cell therapy directed at any target

Cannot have received: BCMA-targeting therapy

Prior BCMA-targeting therapy

Lab requirements

Cardiac function

Oxygen saturation < 95% on room air; Systolic blood pressure <100mmHg; NT-proBNP > 8500ng/L and high sensitivity cardiac troponin T ≥ 50 ng/L or cardiac Troponin T ≥ 0.035 ng/mL or cardiac Troponin I ≥ 0.1 ng/mL; NT-proBNP ≥ 2000 ng/L (dose escalation); NT-proBNP < 2000 and > 8500 ng/L (dose extension); NYHA class III or IV

Oxygen saturation < 95% on room air; Systolic blood pressure <100mmHg; Mayo Stage IIIb AL amyloidosis as defined by NT-proBNP>8500ng/L, and high sensitivity cardiac troponin T ≥ 50 ng/L cardiac Troponin T ≥ 0.035 ng/mL or cardiac Troponin I ≥ 0.1 ng/mL; NT-proBNP levels as follows: NT-proBNP ≥ 2000 ng/L (for dose escalation portion), NT-proBNP < 2000 and > 8500 ng/L (for dose extension portion); NYHA class III or IV

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT07250269 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior CAR-T cell therapy, BCMA-targeting therapy disqualifies patients from enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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