OncoMatch/Clinical Trials/NCT05219721
A Study of CAR-GPRC5D in Patients With Relapsed/Refractory Multiple Myeloma or Plasma Cell Leukemia
Is NCT05219721 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies CAR-T (CAR-GPRC5D) for relapsed/refractory multiple myeloma.
Treatment: CAR-T (CAR-GPRC5D) — This study is a single-center, open-label, dose-exploration study to observe the safety and efficacy of different doses of CAR-GPRC5D in patients with R/R MM or plasma cell leukemia.
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: GPRC5D overexpression (cell membrane expression by IHC or flow cytometry)
Evidence of cell membrane GPRC5D expression, as determined by a validated immunohistochemistry (IHC) or flow cytometry of tumor tissue
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: proteasome inhibitor
at least 3 prior lines of therapy including chemotherapy based on proteasome inhibitors (PIs) and immunomodulatory agents (IMiDs)
Must have received: immunomodulatory agent
at least 3 prior lines of therapy including chemotherapy based on proteasome inhibitors (PIs) and immunomodulatory agents (IMiDs)
Cannot have received: monoclonal antibody
monoclonal antibody for treating multiple myeloma within 21 days before leukapheresis
Cannot have received: cytotoxic chemotherapy
cytotoxic therapy or proteasome inhibitors within 14 days before leukapheresis
Cannot have received: proteasome inhibitor
cytotoxic therapy or proteasome inhibitors within 14 days before leukapheresis
Cannot have received: immunomodulatory agent
immunomodulatory agents within 7 days before leukapheresis
Cannot have received: other anti-tumor treatments
anti-tumor treatments other than those listed above within 30 days before leukapheresis
Lab requirements
Blood counts
ANC ≥1×10^9 /L (no growth factor within 7 days); ALC ≥0.3×10^9 /L; platelets ≥40×10^9 /L (no transfusion within 7 days); hemoglobin ≥60 g/L (no RBC transfusion within 7 days; erythropoietin permitted)
Kidney function
Creatinine clearance rate (CrCl) ≥ 40 ml/min
Liver function
ALT and AST ≤ 2.5×ULN; total serum bilirubin ≤ 1.5×ULN
Cardiac function
LVEF ≥ 50%
Subjects should have adequate organ function: Hematology: ANC ≥1×10^9 /L...LVEF ≥ 50%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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