Phase I Study of T Cells Expressing an Anti-CD19 Chimeric Receptor in Children and Young Adults With B Cell Leukemia
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Leukemia
- Sponsor
- Kecellitics Biotech Company Ltd
- Enrollment
- 100
- Primary Endpoint
- Survival time of Anti-CD19 CAR T cells in vivo
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
This study aims to evaluate the safety, efficacy and duration of response of CD19 Chimeric Antigen Receptor (CAR) redirected autologous T-cells in patients with high risk, relapsed CD19+ haematological malignancies.
Detailed Description
This is a multi-centre, non-randomised, open label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product named CD19 Chimeric Antigen Receptor (CAR) T-cells (CD19 CAR T-cells) in patients with high risk, relapsed CD19+ Leukemia. Following informed consent and registration to the trial, patients will undergo an unstimulated leukapheresis for the generation of the CD19 CAR Tcells. Patients will receive the CD19CAR T-cells following lymphodepleting chemotherapy. The study will evaluate the safety, efficacy and duration of response of the CD19 CAR T-cells in patients with high risk relapsed CD19+ Leukemia
Investigators
Eligibility Criteria
Inclusion Criteria
- •Relapsed or refractory B cell Leukemia.
- •Life expectancy\>3 months.
- •Gender unlimited, age from 2 years to 70 years.
- •CD19 expression must be detected on greater than 15% of the malignant cells by immunohistochemistry or greater than 30% by flow cytometry.
- •Patients who have failed at least one line of a standard treatment.
- •No serious mental disorder.
- •Patients must have adequate cardiac function(no cardiac disease, LVEF≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of \>94%, and adequate renal function(Cr≤133umol/L).
- •No other serious diseases(autoimmune disease, immunodeficiency etc.).
- •No other tumors.
- •Patients volunteer to participate in the research.
Exclusion Criteria
- •Patients are allergic to cytokines.
- •Uncontrolled active infection.
- •Acute or chronic GVHD.
- •Treated with T cell inhibitor.
- •Pregnancy and nursing females.
- •HIV/HBV/HCV Infection.
- •Other situations we think improper for the research.
Outcomes
Primary Outcomes
Survival time of Anti-CD19 CAR T cells in vivo
Time Frame: 3 years
To evaluate the presence of circulating CAR T cells with flow cytometry and real time PCR in patient blood.
Antitumor Effects
Time Frame: Every 3 months post treatment up to 24 months
Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis.
Maximum tolerated dose (MTD) of CD19 targeted CAR T cells.
Time Frame: 4 weeks
Maximum tolerated dose (MTD) of CD19 targeted CAR T cells.
Adverse events of each patient
Time Frame: 3 years
Determine the toxicity profile of the CD19 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.