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OncoMatch/Clinical Trials/NCT06644443

BCMA-GPRC5D CAR-T Therapy in Relapsed or Refractory Multiple Myeloma

Is NCT06644443 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies BCMA-GPRC5D CAR-T cells for multiple myeloma in relapse.

Phase 1/2RecruitingShenzhen University General HospitalNCT06644443Data as of May 2026

Treatment: BCMA-GPRC5D CAR-T cellsAt present, MM is still an incurable disease in general, and the vast majority of patients will eventually face disease recurrence or progression. Although CAR-T therapy targeting BCMA has shown advantages in the efficacy and safety of MM, for MM patients with BCMA negative or BCMA low expression, they still relapse after receiving targeted BCMA CAR T-cell therapy, and there is a problem of target escape. The specific high expression of GPRC5D in multiple myeloma cells makes it possible to combine BCMA and GPRC5D in the treatment of MM. This study aims to investigate the safety and efficacy of BCMA-GPRC5D CAR-T therapy in the treatment of relapsed or refractory MM.

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Extracted eligibility criteria

Cancer type

Multiple Myeloma

Biomarker criteria

Required: BCMA (TNFRSF17) overexpression (positive)

myeloma cells have positive BCMA ... expression

Required: GPRC5D overexpression (positive)

myeloma cells have positive ... GPRC5D expression

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 1 prior line

Must have received: chemotherapy regimen containing bortezomib (bortezomib)

use chemotherapy regimens containing bortezomib, the treatment is ineffective, or the disease progresses within 60 days after the end of the last chemotherapy

Must have received: chemotherapy regimen containing lenalidomide (lenalidomide)

use chemotherapy regimens containing lenalidomide, the treatment is ineffective, or the disease progresses within 60 days after the end of the last chemotherapy

Cannot have received: allogeneic hematopoietic stem cell transplantation

After allogeneic hematopoietic stem cell transplantation

Lab requirements

Blood counts

hemoglobin ≥ 80g/l; ANC ≥ 1000 / mm3 (without GCSF or other growth factors); platelet count ≥ 30,000 / mm3 (no blood transfusion required)

Kidney function

blood creatinine < 2.0 mg/dl

Liver function

serum total bilirubin < 1.5 mg/dl; serum ALT or AST ≤ 2.5 x ULN

Cardiac function

NYHA cardiac function class I-II; LVEF ≥ 50%

serum total bilirubin ≥ 1.5 mg/dl; serum ALT or AST greater than 2.5 times the upper limit of normal; blood creatinine ≥ 2.0 mg/dl; hemoglobin<80g/l; does not rely on GCSF or other growth factors, the absolute neutrophil count is less than 1000 / mm3; no blood transfusion is required, and the platelet count is less than 30,000 / mm3; NYHA cardiac function classification standards, patients with grade III or IV cardiac insufficiency; or echocardiographic examination of left ventricular ejection fraction (LVEF) <50%

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