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

B Cell Lymphoma Clinical Trial

Official title:

A Phase I Trial of CD19 Targeted ICAR19 T Cells in Patients With CD19+ Leukemia and Lymphoma.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03383952
• Other study ID #: CD19 Targeted CAR-T
• Status: Recruiting
• Phase: Phase 1
• First received: December 6, 2017
• Last updated: December 19, 2017
• Start date: March 1, 2017
• Est. completion date: December 31, 2025

Study information

• Verified date: December 2017
• Source: Immune Cell, Inc.
• Contact: Xiulian Sun, MD.,Ph.D
• Phone: (+86) 010-62420659
• Email: xiuliansun[@]ymcell.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• B Cell Leukemia
• B Cell Lymphoma
• Leukemia
• Leukemia, B-Cell
• Leukemia, Lymphocytic, Chronic, B-Cell
• Lymphoma
• Lymphoma, B-Cell

Intervention

Biological:
• ICAR19 CAR-T cells
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.

Locations

Country	Name	City	State
China	Weifang People's Hospital	Weifang	Shandong

Sponsors (2)

Lead Sponsor	Collaborator
Immune Cell, Inc.	Weifang People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure the safety of ICAR19 CAR-T cells	To assess the adverse events of ICAR19 T cells infusion in patients with CD19+ malignancies	2 years
Secondary	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	3 years
Secondary	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	5 years