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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• The first affiliated hospital, College of Medicine, Zhejiang University
  Hangzhou, Zhejiang, China Recruiting
• 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

Study contacts

• Study coordinator: He Huang, MD, PhD
• Email: hehuangyu@126.com
• Phone: (+86)13605714822

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.