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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 (Jun 2026). This Phase 1 trial studies GC012F for relapsed/refractory al amyloidosis.

Phase 1RecruitingGracell Biotechnologies (Shanghai) Co., Ltd.NCT07250269Data as of Jun 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

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

Must have received: anti-plasma cell-directed therapy

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

Cannot have received: T cell engaging therapy

Exception: within the last 6 months

Prior treatment with any approved or investigational T cell engaging therapies (including T cell-directed bispecific or trispecific therapies) at any target within the last 6 months

Lab requirements

Cardiac function

NT-proBNP ≥ 2000 ng/L (for dose escalation portion); NT-proBNP < 2000 and > 5000 ng/L (for dose extension portion); High-sensitivity cardiac troponin T > 75 ng/L; NYHA class III or IV; Systolic blood pressure <100mmHg; Oxygen saturation < 95% on room air

NT-proBNP levels as follows: NT-proBNP ≥ 2000 ng/L (for dose escalation portion) NT-proBNP < 2000 and > 5000 ng/L (for dose extension portion) High-sensitivity cardiac troponin T > 75 ng/L NYHA class III or IV Systolic blood pressure <100mmHg Oxygen saturation < 95% on room air

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, T cell engaging 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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