Safety and Efficacy of GPRC5D CAR-T Cell Therapy in Relapsed/Refractory Plasma Cell Disorders (NCT07365059) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
Safety and Efficacy of GPRC5D CAR-T Cell Therapy in Relapsed/Refractory Plasma Cell Disorders
18 participantsStarted 2026-01-25
Plain-language summary
This study is an open-label, single-arm, dose-escalation and expansion, prospective clinical trial. It enrolls patients with relapsed/refractory plasma cell disorders, administers GPRC5D CAR-T cell therapy, follows up to observe adverse reactions after medication, collects relevant data on treatment efficacy, evaluates the safety and efficacy of CAR-T cells, and simultaneously investigates the cellular kinetic characteristics of CAR-T cells.
Who can participate
Age range14 Years – 75 Years
SexALL
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Inclusion Criteria:
Subjects must meet all of the following criteria:
* According to the World Health Organization (WHO) Classification of Haematopoietic and Lymphoid Tissue Tumours (2022), patients with relapsed/refractory plasma cell disorders that have received adequate treatment and lack effective therapeutic options, including: multiple myeloma, plasma cell leukemia, extramedullary plasmacytoma, solitary plasmacytoma, or primary amyloidosis.i) Relapsed: Disease progression occurs after one or more prior treatments, requiring salvage therapy, and does not meet the criteria for refractory disease.ii) Refractory: No response to initial treatment regimen or salvage therapy, or disease progression within 60 days after treatment. No response is defined as failure to achieve minimal response (MR) or disease progression during treatment.
* The subject's predicted survival time is not less than three months.
* Tumor cells confirmed to be GPRC5D positive by Flow Cytometry (FCM) or Immunohistochemistry.
* The subject failed autologous and allogeneic hematopoietic stem cell transplantation.
* Age 14-75 years (inclusive), both genders eligible.
* ECOG performance status ≤ 2.
* HGB≥70g/L(transfusion permitted).
* The functions of vital organs need to meet the following conditions: ①Creatinine ≤ 2.5 × ULN or Cockcroft-Gault creatinine clearance \> 50 ml/min (excluding decreased serum creatinine clearance due to lymphoma mass compression), Combination with hemodialysis treatment is pe…
What they're measuring
1
Monitor and record adverse events
Timeframe: up to two years after the CAR-T cell infusion
2
Overall Response Rate
Timeframe: up to two year after the CAR-T cell infusion