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

Immune Cell, Inc.20 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

B Cell Leukemia B Cell Lymphoma

Interventions

ICAR19 CAR-T cellsBIOLOGICAL

T cells were isolated from peripheral blood from patients enrolled. T cells were transduced with lentivirus bearing anti-CD19 antibody scFV and the activation signals of second generation CART designation. The CART cells were infused into the patients by IV with an escalating dosage.

Eligibility

Sex: ALLMin age: 2 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Weifang People's Hospital

Weifang, Shandong, China

RECRUITING

Outcomes

Primary Outcomes

Measure the safety of ICAR19 CAR-T cells

To assess the adverse events of ICAR19 T cells infusion in patients with CD19+ malignancies

Time frame: 2 years

Secondary Outcomes

Measure the anti-tumor effect of ICAR19 CAR-T cells

Assess for the therapeutic effects of ICAR 19 CAR-T cells in CD19-expressing leukemia and lymphoma

Time frame: 3 years

Survival time of ICAR19 T cells in vivo.

To measure the survival time of ICAR19 CAR-T cells in vivo, extra blood will be drawn from patients receive ICAR19 T cells infusion in the follow-up time

Time frame: 5 years

Central Contacts

Xiulian Sun, MD.,Ph.D

CONTACT

(+86) 010-62420659 xiuliansun@ymcell.com

Data from ClinicalTrials.gov

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