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 (Jun 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
Treatments studied
Other
Cancer type
Multiple Myeloma
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)
Demographics
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.
Frequently asked questions
Is NCT05219721 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior monoclonal antibody, cytotoxic chemotherapy, proteasome inhibitor disqualifies patients from enrollment.
Does this trial require GPRC5D?
Yes, GPRC5D overexpression is a required biomarker for 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.
Check if I qualifyRelated pages