NCT06271252 A Study to Evaluate the Safety, PK/PD of (OriCAR-017) in Subjects With RR/MM - RIGEL Study
| NCT ID | NCT06271252 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | OriCell Therapeutics Co., Ltd. |
| Condition | Neoplasms, Plasma Cell |
| Study Type | INTERVENTIONAL |
| Enrollment | 81 participants |
| Start Date | 2024-04-03 |
| Primary Completion | 2026-12-12 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
The is a first clinical study for Oricell Therapeutics Inc. in the United States to evaluate the safety, PK, PD and preliminary efficacy of our anti-GPRC5D cell product (OriCAR-017) in subjects with relapsed/refractory multiple myeloma. RIGEL Study
Eligibility Criteria
Inclusion Criteria: Capable of giving signed informed consent Subjects aged 18 to 75 years (inclusive) at Screening (signing the ICF). Expected survival period is \>12 weeks. Diagnosis of MM according to the IMWG criteria (2016 version). One of the following criteria must be met: If immunoglobulin (Ig)G type MM, then serum M protein \>10 g/L; if IgA, IgD, IgE or IgM type MM, then serum M protein \>5 g/L Urine M protein level \>200 mg/24 hour If light chain type MM, then serum free light chain (sFLC) \>100 mg/L and K/λ FLC ratio is abnormal. Extramedullary lesions (\>1 cm for diameter of the short axis). For Phase I (dose-escalation) - Subjects who had received at least 3 prior lines of therapy, had previous exposure to BCMA-Ag+ therapies, and were refractory to the last line of therapy. For Phase I (dose-expansion) and Phase II: Subjects with previous exposure to BCMA directed therapies including BCMA bispecific antibody (e.g., teclistamab), BCMA antibody directed conjugate (such as BL