A Study of OL-101 Injection in Patients with Relapsed or Refractory Multiple Myeloma (RRMM)

Recruiting now · Phase 1

Conditions studied: Multiple Myeloma

In brief

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).

Key facts

Study ID

NCT06644118

Run by

Zhejiang University

People needed

58

Starts

2024-10-23

Expected to finish

2028-10-01

Last updated by the study team

2024-11-08

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• The first affiliated hospital, College of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (enrolling)
• Beijing Gobroad Boren Hospital — Beijing, Beijing Municipality, China
• The Affiliated Hospital of Northwest University Xi'an No.3 Hospital — Xi’an, Shanxi, China

Full record on ClinicalTrials.gov

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