Autologous CD8+ T-cells Expressing an Anti-BCMA CAR in Patients With Myeloma
Phase 1
Terminated
- Conditions
- Multiple Myeloma
- Interventions
- Registration Number
- NCT03448978
- Lead Sponsor
- Cartesian Therapeutics
- Brief Summary
This Phase I study will test the safety and anti-myeloma activity of ascending doses of Descartes-08 (autologous CD8+ T-cells expressing an anti-BCMA chimeric antigen receptor) in eligible patients with active multiple myeloma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 32
Inclusion Criteria
Not provided
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Descartes-08 plus fludarabine/cyclophosphamide pretreat Descartes-08 Autologous CD8+ T-cells transiently expressing an anti-BCMA chimeric antigen receptor Descartes-08 plus fludarabine/cyclophosphamide pretreat Fludarabine Autologous CD8+ T-cells transiently expressing an anti-BCMA chimeric antigen receptor Descartes-08 plus fludarabine/cyclophosphamide pretreat Cyclophosphamide Autologous CD8+ T-cells transiently expressing an anti-BCMA chimeric antigen receptor
- Primary Outcome Measures
Name Time Method Incidence (number) of Treatment-Emergent Adverse Events [Safety and Tolerability] 2 weeks Incidence (number) of Treatment-Emergent Adverse Events \[Safety and Tolerability\]. Descriptive statistics by incidence rate, body system classification, severity, and causality \[per protocol definitions\]
- Secondary Outcome Measures
Name Time Method Treatment response 1, 3, 6, 9 and 12 months IMWG treatment response criteria
Trial Locations
- Locations (3)
The Center for Cancer and Blood Disorders
🇺🇸Bethesda, Maryland, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Virgina Cancer Specialists
🇺🇸Fairfax, Virginia, United States