OncoMatch/Clinical Trials/NCT06644118
A Study of OL-101 Injection in Patients with Relapsed or Refractory Multiple Myeloma (RRMM)
Is NCT06644118 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies OL-101 infusion for multiple myeloma.
Treatment: OL-101 infusion — This clinical trial aims to characterize the safety of OL-101 and establish the recommended dose for future research and to evaluate the efficacy of OL-101 (Dose expansion).
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Biomarker criteria
Required: BCMA (TNFRSF17) positive expression
Positive expression of either BCMA or GPRC5D on bone marrow plasma cells
Required: GPRC5D positive expression
Positive expression of either BCMA or GPRC5D on bone marrow plasma cells; must be GPRC5D expression positive if previously received BCMA targeted therapy
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: proteasome inhibitor
must include a PI
Must have received: immunomodulatory agent
must include an IMiD
Must have received: anti-CD38 antibody
must include an anti-CD38 antibody
Cannot have received: allogeneic stem cell transplant
Received allogeneic stem cell transplant
Cannot have received: autologous stem cell transplant
Exception: within 12 weeks before screening
received autologous stem cell transplant within 12 weeks before screening
Lab requirements
Blood counts
hemoglobin ≥ 70 g/L; platelet count ≥ 50 × 10^9/L; absolute lymphocyte count ≥ 0.3×10^9/L; absolute neutrophil count ≥ 1.0 × 10^9/L
Kidney function
creatinine clearance ≥ 60 mL/min (Cockcroft-Gault)
Liver function
ALT and AST ≤ 2.5x ULN; total bilirubin ≤ 2x ULN (except congenital bilirubinemia: direct bilirubin ≤1.5x ULN)
Cardiac function
LVEF ≥ 50% by echocardiogram; no clinically meaningful pericardial effusion by ultrasound
Adequate bone marrow reserve or organ function meeting the following criteria: 1. Hemoglobin ≥ 70 g/L 2. Platelet count ≥ 50 × 10^9/L 3. Absolute lymphocyte count ≥ 0.3×10^9/L 4. Absolute neutrophil count ≥ 1.0 × 10^9/L 5. ALT and AST ≤ 2.5x ULN 6. Total bilirubin ≤ 2x ULN; except in subjects with congenital bilirubinemia (such as Gilbert syndrome, in which case the direct bilirubin ≤1.5 × ULN is required) 7. Creatinine clearance ≥ 60 mL/min (Cockcroft-Gault) 8. corrected serum calcium ≤12.5 mg/dL (≤3.1 mmol/L) or free ionized calcium ≤6.5 mg/dl (≤1.6 mmol/L) 9. SpO2>92% on room air 10. LVEF ≥ 50% as assessed by echocardiogram; no clinically meaningful pericardial effusion by ultrasound
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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