eligibility_summary
IMWG 2014 MM, relapsed/refractory after ≥3 prior lines incl PI, IMiD, anti‑CD38 with progression ≤12 mo (or ≤6 mo with nonresponse). Measurable disease. BCMA or GPRC5D+ marrow plasma cells (GPRC5D+ if prior BCMA). ECOG 0–1, life >12 wks, adequate marrow/organ (Hb≥70 g/L, Plt≥50×10^9/L, ANC≥1.0, CrCl≥60, AST/ALT≤2.5×ULN, bili≤2×ULN, LVEF≥50%). Exclude: solitary plasmacytoma, CNS MM, prior allo‑SCT/auto‑SCT <12 wks, active malignancy (except select), major comorbidity, PCL, WM, POEMS, AL.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: OL-101, an autologous dual-target CAR-T cell therapy (biologic) delivered by IV infusion. Mechanism of action: patient T cells are engineered to express chimeric antigen receptors that recognize BCMA and GPRC5D on myeloma cells, antigen binding triggers CAR signaling to activate T-cell cytotoxicity (cytokine release and perforin/granzyme-mediated lysis). Dual targeting is intended to improve killing and limit antigen escape versus single-antigen CAR-Ts. Cells/pathways targeted: malignant plasma cells in relapsed/refractory multiple myeloma expressing BCMA (B-cell maturation antigen, TNFRSF17) and/or GPRC5D (orphan GPCR). Engages BCMA- and GPRC5D-expressing myeloma cell pathways and activates effector CD8+/CD4+ T cells via CAR signaling (CD3ζ with co-stimulation). Study design: Phase 1, single-arm, dose escalation/expansion to define dose, safety, PK/PD, and preliminary efficacy.