Phase I, Interventional, Single Arm, Open Label, Treatment Study to Evaluate the Safety and Tolerability of BCMA-CS1 cCAR in Patients With Relapsed and/or Refractory Multiple Myeloma
Overview
- Phase
- Early Phase 1
- Intervention
- Not specified
- Conditions
- Multiple Myeloma
- Sponsor
- iCell Gene Therapeutics
- Enrollment
- 12
- Locations
- 2
- Primary Endpoint
- Number of participants with adverse event by severity as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
- Last Updated
- 6 years ago
Overview
Brief Summary
This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of BCMA-CS1 cCAR in patients with relapsed and/or refractory multiple myeloma.
Detailed Description
BCMA-CS1 cCAR (Compound CAR BCMA-CS1) is a chimeric antigen receptor immunotherapy treatment designed to treat multiple myeloma using two different antigen targets, BCMA (CD269) and CS1 (SLAMF7). The use of two different targets widely expressed on plasma cells, BCMA and CS1, intends to increase coverage and eradicate cancerous cells before resistance develops in surviving cancer cells that have undergone selective pressures or antigen escape. BCMA-CS1 cCAR bears two distinct functional CAR molecules expressed on a T-cell, directed against the surface proteins BCMA and CS1.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis based on the World Health Organization (WHO) 2008
- •Patients have exhausted standard therapeutic options
- •Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 4 weeks
- •Female must be not pregnant during the study
Exclusion Criteria
- •Prior solid organ transplantation
- •Potentially curative therapy including chemotherapy or hematopoietic cell transplant
- •Prior treatment with BCMAxCD3 or CS1xCD3 bispecific agents
Outcomes
Primary Outcomes
Number of participants with adverse event by severity as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time Frame: 2 years
Number of participants with dose limiting toxicity (DLT) as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time Frame: 28 days
Type of dose-limiting toxicity (DLT)
Time Frame: 28 days
Secondary Outcomes
- Overall Response Rate (ORR)(1 year)
- Progression-free survival (PFS)(1 year)
- Overall survival(1 year)