NCT06644118 A Study of OL-101 Injection in Patients with Relapsed or Refractory Multiple Myeloma (RRMM)
| NCT ID | NCT06644118 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Zhejiang University |
| Condition | Multiple Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 58 participants |
| Start Date | 2024-10-23 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 58 participants in total. It began in 2024-10-23 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
Inclusion Criteria: * Documented diagnosis of multiple myeloma according to the 2014 IMWG diagnostic criteria * Relapsed/refractory multiple myeloma as defined by: 1\) Received at least 3 prior lines of MM treatment (must include a PI, an IMiD, and an anti-CD38 antibody). 2）Disease progression within 12 months of the most recent anti-MM therapy; or disease progression within the past 6 months and subsequently lack response to the most recent line of therapy. * Measurable disease at screening as defined by any of the following: 1. Serum monoclonal paraprotein (M-protein) level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours; or 2. Light chain multiple myeloma without measurable disease in the serum or the urine: Serum immunoglobulin free light chain ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio. * Positive expression of either BCMA or GPRC5D on bone marrow plasma cells; must be GPRC5D expression positive if previously received BCMA targeted therapy * ECOG 0-1 * Expected life expectancy exceeds 12 weeks * 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. Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal (ULN) 6. Total bilirubin ≤ 2 times 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 (calculated by Cockcroft-Gault equation). 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. Left ventricular ejection fraction (LVEF) ≥ 50% as assessed by echocardiogram; no clinically meaningful pericardial effusion by ultrasound Exclusion Criteria: * Solitary plasmacytoma * Known active central nervous system (CNS) involvement or exhibits clinical signs of CNS involvement of multiple myeloma. * Received allogeneic stem cell transplant; received autologous stem cell transplant within 12 weeks before screening * Active second primary malignant tumor, exclude the following: cured non- melanoma skin cancer, non-metastatic prostate cancer, cervical carcinoma in situ, ductal or lobular carcinoma in situ of the breast * Any other significant medical disease, abnormality, or condition that, in the investigator judgment, may make the patient unsuitable for participation in the study or put the patient at risk. * Plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome, or primary AL amyloidosis.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06644118 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Multiple Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06644118 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06644118 currently recruiting?
Yes, NCT06644118 is actively recruiting participants. Contact the research team at hehuangyu@126.com for enrollment information.
Where is the NCT06644118 trial being conducted?
This trial is being conducted at Beijing, China, Xi’an, China, Hangzhou, China.
Who is sponsoring the NCT06644118 clinical trial?
NCT06644118 is sponsored by Zhejiang University. The trial plans to enroll 58 participants.