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

Who is this study for? Patients with B-cell Leukemia
What treatments are being studied? ICAR19 CAR-T Cells
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 80
Healthy Volunteers: f
View:

⁃ 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.

Locations
Other Locations
China
Weifang People's Hospital
RECRUITING
Weifang
Contact Information
Primary
Xiulian Sun, MD.,Ph.D
xiuliansun@ymcell.com
(+86) 010-62420659
Time Frame
Start Date: 2017-03-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 20
Treatments
Experimental: 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.
Sponsors
Collaborators: Weifang People's Hospital
Leads: Immune Cell, Inc.

This content was sourced from clinicaltrials.gov