A Clinical Study of CD19 Targeted CAR-T for Patients With CD19+ Lymphoma and Leukemia

Immune Cell, Inc.

Status and phase: Enrolling; Phase 1

Conditions: B Cell Leukemia; B Cell Lymphoma

Treatments: Biological: ICAR19 CAR-T cells

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03383952

CD19 Targeted CAR-T

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 2 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

ICAR19 CAR-T cells

Experimental group

Description:

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.

Treatment:

Biological: ICAR19 CAR-T cells