Modified Immune Cells (CD19-CD22 CAR T Cells) in Treating Patients With Recurrent or Refractory CD19 Positive, CD22 Positive Leukemia or Lymphoma
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- CD19 Positive
- CD22 Positive
- Minimal Residual Disease
- Progressive Disease
- Recurrent B Acute Lymphoblastic Leukemia
- Recurrent Chronic Lymphocytic Leukemia
- Recurrent Non-Hodgkin Lymphoma
- Refractory B Acute Lymphoblastic Leukemia
- Refractory Chronic Lymphocytic Leukemia
- Refractory Non Hodgkin Lymphoma
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 670 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. To determine the safety of infusion with chimeric antigen receptor T cells targeting CD19 and CD22. II. To find the recommended phase II dose for recurrent/refractory CD19+CD22+ B cell malignancies. SECONDARY OBJECTIVES: I. To describe the overall response rate and complete re...
PRIMARY OBJECTIVES: I. To determine the safety of infusion with chimeric antigen receptor T cells targeting CD19 and CD22. II. To find the recommended phase II dose for recurrent/refractory CD19+CD22+ B cell malignancies. SECONDARY OBJECTIVES: I. To describe the overall response rate and complete response rate of relapsed B cell malignancies treated with CAR-T cells targeting CD19 and CD22. II. To assess other response variables including minimal residual disease (MRD) negative remission, overall survival (OS), and event free survival (EFS). EXPLORATORY OBJECTIVES: I. To evaluate the immune reconstitution and persistence of CAR T cells for one year post infusion. OUTLINE: This is a phase I, dose escalation study of autologous CD19/CD22 chimeric antigen receptor T-cells (CD19-CD22 CAR T cells) followed by a phase II study. Patients receive standard of care cyclophosphamide intravenously (IV) over 30 minutes and fludarabine IV over 30 minutes on days -5, -4, and -3, and then receive CD19-CD22 CAR T cells IV on day 0. Patients with relapsed or persistent disease after a protocol assessment may receive a second infusion of CD19-CD22 CAR T cells. After completion of study treatment, patients are followed up at 1, 2, 3, 6, and 12 months.
Tracking Information
- NCT #
- NCT04029038
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Jin S Im M.D. Anderson Cancer Center
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