NCT06182696 OriCAR-017 Chimeric Antigen Receptor (CAR) Modified T Cells for the Treatment of R/RMM
| NCT ID | NCT06182696 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | OriCell Therapeutics Co., Ltd. |
| Condition | Relapsed and/or Refractory Multiple Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 83 participants |
| Start Date | 2023-10-26 |
| Primary Completion | 2026-11-30 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
An open label, dose exploratory clinical study to evaluate the safety, efficacy, and pharmacokinetics of OriCAR-017 in R/RMM
Eligibility Criteria
Main Inclusion Criteria: * Diagnosis of R/RMM according to the IMWG criteria; * Expected survival period is \>12 weeks; * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 or 2 at the time of ICF signature; * The expression of GPRC5D in bone marrow plasma cells membrane is more than 20% by flow cytometry and/or immunohistochemistry, multiple myeloma with measurable lesions, and at least one of the following criteria must be met: 1. Serum M protein \>5 g/L; 2. Urine M protein level \>200 mg/24 hour; 3. Serum free light chain (sFLC) \>100 mg/L and K/λ FLC ratio is abnormal; 4. Primitive immature or monoclonal plasma cells \>5% by bone marrow cytology or flow cytometry. * Subjects who had received at least 3 prior lines of therapy including (but not limited to) immunomodulatory drugs (IMiDs), proteasome inhibitors, anti-CD38 monoclonal antibodies, etc., but have failed treatment, including those who have experienced relapse (within 12 months), refractory or intolerant to