A Phase 1 interventional study of OL-101 infusion in Multiple Myeloma, sponsored by Zhejiang University. Recruiting at 3 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-11-08.
Sponsored by Zhejiang University · Phase 1, Interventional, and Treatment
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).
This study will evaluate the safety and efficacy of OL-101, a chimeric antigen receptor T cell (CAR-T) therapy directed against B-Cell Maturation Antigen (BCMA) and G Protein-Coupled Receptor Class C Group 5 Member D (GPRC5D). This study is a single-arm, open-label, early exploratory clinical trial, conducted in two phases: dose escalation and dose expansion in adults with multiple myeloma. The trial begins with the dose-escalation phase that focus on safety and tolerability, with interval assessments for potential dose escalation or de-escalation. Recommended dose will be selected at the completion of the dose escalation stage in the dose expansion stage. The study aims to assess safety, pharmacokinetic/pharmacodynamic profiles, and efficacy.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's planned enrollment of 58 is above the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Zhejiang University is the lead sponsor of 351 studies on the registry; 165 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Relapsed/refractory multiple myeloma as defined by:
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:
Adequate bone marrow reserve or organ function meeting the following criteria:
Exclusion Criteria:
This arm provides CAR-T treatment at the dose the patient is assigned to.
Biological: OL-101 infusion
OL-101 infusion will be administered to patients via IV infusion at the assigned dose.
Dose-limiting toxicity (DLT)
Adverse events will be assessed based on the CTCAE 5.0
Time frame: Within 28 days post CAR-T infusion
Treatment emergent adverse event (TEAE) incidence and severity
Adverse events will be assessed based on the CTCAE 5.0
Time frame: From aphresis till 1 year after CAR-T infusion or start of a new anti-cancer therapy, whichever is earlier
Level of Immunogenicity
To assess the presence of antibodies to OL-101 (ADA)
Time frame: Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first
Level of RCL
To determine whether Replication Competent Lentivirus (RCL) is present in patient that receive OL-101
Time frame: Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first
Overall response rate (ORR)
Proportion of subjects with PR or above
Time frame: Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first
Minimal residual disease (MRD) negative rate
Proportion of subjects with MRD negative status as defined by the IMWG response criteria
Time frame: Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first
Duration of response (DOR)
The time from the initial response to therapy until the disease progression or relapse.
Time frame: Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first
Progression-free survival (PFS)
The time from CAR-T cell infusion to the first assessment of disease progression or death from any cause.
Time frame: Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first
Overall survival (OS)
The time from CAR-T cell infusion to death from any cause.
Time frame: Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first
Cmax of OL-101
The maximum concentration of the CAR-T cells will be measured to assess OL-101 in vivo expansion and persistence.
Time frame: Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first
Tmax of OL-101
The time of the maximum concentration will be measured to assess OL-101 in vivo expansion and persistence.
Time frame: Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first
AUC 0-28days of OL-101
Area under the curve will be measured to assess OL-101 in vivo expansion and persistence.
Time frame: Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first
Serum cytokines
The levels of cytokines will be measured, such as IL-6 and ferritin.
Time frame: Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first
Serum soluble circulating BCMA (sBCMA)
Serum soluble circulating BCMA will be measured to explore its potential relationship to response or resistance.
Time frame: Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first
Plan to share: No
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Zhejiang University