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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 (Jun 2026). This Phase 1/2 trial studies GC012F for multiple myeloma.

Phase 1/2RecruitingGracell Biotechnologies (Shanghai) Co., Ltd.NCT06235229Data as of Jun 2026Location: China

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

Treatments studied

Other

GC012F

Cancer type

Multiple Myeloma

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≤ 75

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.

Frequently asked questions

Is NCT06235229 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior CAR-T cell therapy, allogeneic hematopoietic stem cell transplantation, autologous hematopoietic stem cell transplantation disqualifies patients from enrollment.

Is there an age limit?

Yes. Patients must be 75 years or younger.

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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