NCT04029038

Modified Immune Cells (CD19-CD22 CAR T Cells) in Treating Patients With Recurrent or Refractory CD19 Positive, CD22 Positive Leukemia or Lymphoma

Phase I/II Study of Dual CD19-CD22 Chimeric Antigen Receptor (CAR) T Cells in Patients With Advanced CD19+ CD22+ Lymphoid Malignancies

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 6 Months – 70 Years
• Healthy volunteers: Not accepted

Summary

This phase I/II trial studies the side effects and best dose of modified immune cells called CD19-CD22 chimeric antigen receptor (CAR) T cells in treating patients with CD19 positive(+), CD22+ B-acute lymphoblastic leukemia, chronic lymphocytic leukemia, or non-Hodgkin's lymphoma that has come back (recurrent) or does not respond to treatment (refractory). T-cells are collected from the patient and genetic materials called "chimeric antigen receptors (CAR)" are transferred to the collected T-cells. The CAR T-cells are then infused back to the patient's body. Giving CD19- CD22 CAR T cells after chemotherapy may help to control the disease.

Detailed 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 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.

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

Interventions

Type	Name	Description
BIOLOGICAL	Autologous CD19/CD22 Chimeric Antigen Receptor T-cells	Given IV
DRUG	Cyclophosphamide	Given IV
DRUG	Fludarabine	Given IV

Timeline

• Start date: 2019-05-15
• Primary completion: 2022-11-16
• Completion: 2022-11-16
• First posted: 2019-07-23
• Last updated: 2023-08-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study