Descartes-11 in Patients With Relapsed/Refractory Multiple Myeloma
Phase 1
Terminated
- Conditions
- Multiple Myeloma
- Interventions
- Registration Number
- NCT03994705
- Lead Sponsor
- Cartesian Therapeutics
- Brief Summary
This Phase I study will test the safety and anti-myeloma activity of ascending doses of Descartes-11 (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
- 20
Inclusion Criteria
- Active multiple myeloma that is refractory after at least 2 prior lines of therapy;
- measurable disease;
- adequate vital organ function; and
- no active infection.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Dose Level 1 Descartes-11 Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 10 million cells of Descartes-11 via intravenous catheter on Days 7,14 Dose Level 1 Fludarabine Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 10 million cells of Descartes-11 via intravenous catheter on Days 7,14 Dose Level 1 Cyclophosphamide Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 10 million cells of Descartes-11 via intravenous catheter on Days 7,14 Dose Level 2 Descartes-11 Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 32 million cells of Descartes-11 via intravenous catheter on Days 7,14 Dose Level 2 Fludarabine Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 32 million cells of Descartes-11 via intravenous catheter on Days 7,14 Dose Level 2 Cyclophosphamide Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 32 million cells of Descartes-11 via intravenous catheter on Days 7,14 Dose Level 3 Descartes-11 Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 100 million cells of Descartes-11 via intravenous catheter on Days 7,14 Dose Level 3 Fludarabine Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 100 million cells of Descartes-11 via intravenous catheter on Days 7,14 Dose Level 3 Cyclophosphamide Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 100 million cells of Descartes-11 via intravenous catheter on Days 7,14 Dose Level 4 A Fludarabine Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 150 million cells of Descartes-11 via intravenous catheter on Days 7,14,21 Dose Level 4 A Descartes-11 Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 150 million cells of Descartes-11 via intravenous catheter on Days 7,14,21 Dose Level 4 A Cyclophosphamide Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 150 million cells of Descartes-11 via intravenous catheter on Days 7,14,21 Dose Level 4B Descartes-11 Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 150 million cells of Descartes-11 via intravenous catheter on Days 7,10,14,21 Dose Level 4B Fludarabine Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 150 million cells of Descartes-11 via intravenous catheter on Days 7,10,14,21 Dose Level 4B Cyclophosphamide Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 150 million cells of Descartes-11 via intravenous catheter on Days 7,10,14,21 Dose Level 4C Descartes-11 Participants were not administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 150 million cells of Descartes-11 via intravenous catheter on Days 1,4, 7,10,14,21
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment-Related Adverse Events Time Frame: 21 days Determine the safety of Descartes-11 in patients with relapsed/refractory multiple myeloma
- Secondary Outcome Measures
Name Time Method Disease Assessment Based on International Myeloma Working Group (IMWG) Criteria Disease assessment is on Day 21 (or at least 14 days after first Descartes-11 infusion) Patience with Complete response (CR) according to the International Myeloma Working Group (IMWG).
Trial Locations
- Locations (2)
Center for Cancer and Blood Disorders
🇺🇸Bethesda, Maryland, United States
Medical College of Wisconsin
🇺🇸Madison, Wisconsin, United States