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

Phase 1

Recruiting

• Conditions: B Cell Leukemia; B Cell Lymphoma
• Interventions: Biological: ICAR19 CAR-T cells

• Registration Number: NCT03383952
• Lead Sponsor: Immune Cell, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-01
• Status Verified: 2017-12
• Study First Submitted: 2017-12-06
• Study First Submitted QC: 2017-12-19
• Last Update Submitted: 2017-12-19
• Study First Posted: 2017-12-27
• Last Update Posted: 2017-12-27
• Primary Completion: 2020-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ICAR19 CAR-T cells	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.

Primary Outcome Measures

Name	Time	Method
Measure the safety of ICAR19 CAR-T cells	2 years	To assess the adverse events of ICAR19 T cells infusion in patients with CD19+ malignancies

Secondary Outcome Measures

Name	Time	Method
Measure the anti-tumor effect of ICAR19 CAR-T cells	3 years	Assess for the therapeutic effects of ICAR 19 CAR-T cells in CD19-expressing leukemia and lymphoma
Survival time of ICAR19 T cells in vivo.	5 years	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

Trial Locations

Locations (1)

Weifang People's Hospital; 🇨🇳 Weifang, Shandong, China