A Phase I Trial of CD19 Targeted ICAR19 T Cells in Patients With CD19+ Leukemia and Lymphoma.
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Measure the safety of ICAR19 CAR-T cells
Study Overview
Brief Summary
Immunotherapy offers an extremely precise approach with the potential to eliminate cancer cells specifically. The newly designed CD19 targeted ICAR19 T cells can specifically kill CD19+ tumor cells. ICAR19 CART used the second generation of CART designation. In this study, the participants will receive several doses of autologous ICAR19 T cells and the investigators will determine the safety and therapeutic effects of these cells.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 2 Years to 80 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •CD19 positive leukemia and lymphoma，relapsed and/or refractory：
- •survival>12 weeks;
- •FEV1, FVC and DLCO ≥50% of expected corrected for hemoglobin;
- •LVEF≥50%;
- •Creatinine<2.5mg/dl;
- •Bilirubin<2.5mg/dl;
- •ALT (alanine aminotransferase)/AST (aspartate aminotransferase)<3 x normal;
- •At least 7 days after last chemotherapy;
- •provide with informed consent.
Exclusion Criteria
- •Active clinically significant CNS dysfunction
- •Pregnant or breast-feeding women.
- •Uncontrolled active infection including hepatitis B or C.
- •HIV positive.
- •Use of systemic steroids within 72 hours.
- •Allogeneic lymphocyte treatments within recent 6 months.
- •Any uncontrolled active medical disorder.
Arms & Interventions
ICAR19 CAR-T cells
Immunotherapy offers an extremely precise approach with the potential to eliminate cancer cells specifically. The newly designed CD19 targeted ICAR19 T cells can specifically kill CD19+ tumor cells. ICAR19 CART used the second generation of CART designation. In this study, the participants will receive several doses of autologous ICAR19 CAR-T cells and the investigators will determine the safety and therapeutic effects of these cells.
Intervention: ICAR19 CAR-T cells (Biological)
Outcomes
Primary Outcomes
Measure the safety of ICAR19 CAR-T cells
Time Frame: 2 years
To assess the adverse events of ICAR19 T cells infusion in patients with CD19+ malignancies
Secondary Outcomes
- Measure the anti-tumor effect of ICAR19 CAR-T cells(3 years)
- Survival time of ICAR19 T cells in vivo.(5 years)
Investigators
Xiulian Sun
Principal Investigator
Immune Cell, Inc.