Evaluating OL-101 Injection for Patients with Relapsed or Refractory Multiple Myeloma

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

This study is testing a new treatment called OL-101 to see if it can help adults with multiple myeloma that has come back or hasn’t responded to other treatments.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 58 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Zhejiang University (Academic / other)
• Drugs / interventions: CAR-T, chimeric antigen receptor
• Locations: 3 sites (Beijing, Beijing Municipality and 2 other locations)
• Trial ID: NCT06644118 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of OL-101, a CAR-T therapy targeting BCMA and GPRC5D, in adults with relapsed or refractory multiple myeloma. The study is structured in two phases: a dose escalation phase to assess safety and tolerability, followed by a dose expansion phase to evaluate efficacy. Participants will receive OL-101 infusion, and the trial will monitor pharmacokinetic and pharmacodynamic profiles to determine the recommended dose for future studies.

Who should consider this trial

Good fit: Ideal candidates are adults with relapsed or refractory multiple myeloma who have received at least three prior lines of treatment.

Not a fit: Patients who have not expressed BCMA or GPRC5D on their plasma cells may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat multiple myeloma.

How similar studies have performed: Other studies utilizing CAR-T therapies targeting BCMA have shown promising results, indicating potential for success with this approach.

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.

Where this trial is running

Beijing, Beijing Municipality and 2 other locations

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

Study contacts

• Study coordinator: He Huang, MD, PhD

Conditions Multiple Myeloma; OL-101; Multiple myeloma; Phase 1; single arm