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OncoMatch/Clinical Trials/NCT06235229

A Study of GC012F in Patients With Relapsed/Refractory Multiple Myeloma

Is NCT06235229 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies GC012F for multiple myeloma.

Phase 1/2RecruitingGracell Biotechnologies (Shanghai) Co., Ltd.NCT06235229Data as of May 2026

Treatment: GC012FThis study is a single-arm, open-lable, phase I/II study to evaluate the efficacy and safety of GC012F in subjects with relapsed/refractory multiple myeloma.

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Extracted eligibility criteria

Cancer type

Multiple Myeloma

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 3 prior lines

Must have received: proteasome inhibitor

Prior therapy should include proteasome inhibitors (PIs)

Must have received: immunomodulatory drug

Prior therapy should include immunomodulatory drugs (IMiDs)

Must have received: anti-CD38 antibody

Prior therapy should include anti-CD38 antibodies

Cannot have received: CAR-T cell therapy

Prior treatment with CAR-T products for any target

Cannot have received: allogeneic hematopoietic stem cell transplantation

Exception: Patients undergoing allo-HSCT who have discontinued all immunosuppressive drugs for 6 weeks prior to leukapheresis and have no manifestations of graft-versus-host disease (GVHD) may be enrolled.

Received an allogeneic hematopoietic stem cell transplantation (allo-HSCT) within 6 months prior to leukapheresis

Cannot have received: autologous hematopoietic stem cell transplantation

Received an autologous hematopoietic stem cell transplantation (auto-HSCT) within ≤ 12 weeks prior to leukapheresis

Lab requirements

Blood counts

Neutrophil count ≥ 0.75×10^9/L (growth factor support allowed, but not within 7 days prior to screening); Hemoglobin ≥ 8.0 g/dL (no red blood cell transfusion within 7 days prior to screening, recombinant human erythropoietin allowed); Platelet count ≥ 50×10^9/L (no platelet transfusion within 7 days prior to screening); Lymphocyte count ≥ 0.3×10^9/L

Kidney function

Creatinine clearance ≥ 40 mL/min, calculated by Cockcroft-Gault

Liver function

ALT/AST ≤ 3× ULN; Total bilirubin ≤ 2× ULN (Gilbert syndrome: direct bilirubin ≤ 1.5× ULN)

Cardiac function

LVEF ≥ 45% with no evidence of pericardial effusion as diagnosed by echocardiography; No clinically significant electrocardiogram abnormality observed

Adequate functional reserve of organs: ... see details

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

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