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 (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT06644118 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior allogeneic stem cell transplant, autologous stem cell transplant disqualifies patients from enrollment.
Does this trial require TNFRSF17?
Yes, TNFRSF17 positive expression is a required biomarker for enrollment.
Does this trial require GPRC5D?
Yes, GPRC5D positive expression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages