Tests OL-101 injection in adults with relapsed or refractory multiple myeloma
Tests OL-101 injection for safety and dosing in adults with relapsed or refractory multiple myeloma.
Plain-language title generated from the registry record
Registry title: A Study of OL-101 Injection in Patients with Relapsed or Refractory Multiple Myeloma (RRMM)
Key facts
- Where
- Beijing, Hangzhou, and Xi’an, ChinaSee the 3 sites
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06644118, who can take part
Where in China
- Beijing Gobroad Boren HospitalBeijing, ChinaNot yet recruiting
- The First Affiliated Hospital, College of Medicine, Zhejiang UniversityHangzhou, ChinaTaking people
- The Affiliated Hospital of Northwest University Xi'an No.3 HospitalXi’an, ChinaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Zhejiang University
- Trial code
- NCT06644118
- Record updated
- 8 November 2024
- Original description
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).Read full original descriptionShow less
A Pilot Clinical Study of OL-101 Injection in Patients with Relapsed or Refractory Multiple Myeloma (RRMM)
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).
Inclusion: Documented diagnosis of multiple myeloma according to the 2014 IMWG diagnostic criteria; Relapsed/refractory multiple myeloma as defined by:; 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:; Serum monoclonal paraprotein (M-protein) level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours; or; 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:; 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; Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal (ULN); 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); Creatinine clearance ≥ 60 mL/min (calculated by Cockcroft-Gault equation); corrected serum calcium ≤12.5 mg/dL (≤3.1 mmol/L) or free ionized calcium ≤6.5 mg/dl (≤1.6 mmol/L); SpO2>92% on room air; Left ventricular ejection fraction (LVEF) ≥ 50% as assessed by echocardiogram; no clinically meaningful pericardial effusion by ultrasound.
Exclusion: 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; Solitary plasmacytoma; Known active central nervous system (CNS) involvement or exhibits clinical signs of CNS involvement of multiple myeloma.