Phase I, Interventional, Single Arm, Open Label, Treatment Study to Evaluate the Safety and Tolerability of CD20-CD19 cCAR in Patients With Relapsed and/or Refractory B Cell Malignancies
Overview
- Phase
- Early Phase 1
- Intervention
- Not specified
- Conditions
- B Cell Lymphoma
- Sponsor
- iCell Gene Therapeutics
- Enrollment
- 12
- Locations
- 2
- Primary Endpoint
- 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
- 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 CD20-CD19 cCAR in patients with relapsed and/or refractory B cell malignancies.
Detailed Description
Clinical trials with CD19-directed CARs have achieved unprecedented remission rates as high as 90%. However, recent follow-up studies have shown a substantial portion of treated patients relapsed due to antigen escape. CD20-CD19 cCAR is a compound Chimeric Antigen Receptor (cCAR) immunotherapy with two distinct functional CAR molecules expressed on a T-cell, directed against the surface proteins CD20 and CD19. CD20-CD19 cCAR intends to target the mechanisms of single-CAR relapse, specifically antigen escape.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis based on the World Health Organization (WHO) 2008
- •Histologically demonstrate CD19 or CD20 expressing B cell lymphoma or B ALL
- •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
- •Patients declining to consent for treatment
- •Prior solid organ transplantation
- •Potentially curative therapy including chemotherapy or hematopoietic cell transplant
- •Prior treatment with CD20xCD3 or CD19x3 bispecific agents
Outcomes
Primary Outcomes
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
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
Secondary Outcomes
- Progression-free survival (PFS)(1 year)
- Overall Response Rate (ORR)(1 year)
- Overall survival(1 year)