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New treatment option for Multiple Myeloma
Official title A Study of OL-101 Injection in Patients with Relapsed or Refractory Multiple Myeloma (RRMM)
ClinicalTrials.gov ID: NCT06644118
What this study is testing
What is OL-101 infusion?
OL-101 infusion is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for multiple myeloma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- 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...
You likely can't join 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...
- Any other significant medical disease, abnormality, or condition that, in the investigator judgment, may make the patient unsuitable for...
- Plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome, or primary AL amyloidosis.
See the full eligibility 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...
- 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 people 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Xi’an, Shanxi, China
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Xi’an, Shanxi, China; Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.