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

NCT03383952 | Unknown Phase 1

• 1 other identifier: CD19 Targeted CAR-T
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

B Cell Leukemia; B Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  3 years

• Survival time of ICAR19 T cells in vivo.

  5 years

Study Arms (1)

ICAR19 CAR-T cells

EXPERIMENTAL

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.

Biological: ICAR19 CAR-T cells

Interventions

ICAR19 CAR-T cells BIOLOGICAL

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.

Also known as: Biological drug

ICAR19 CAR-T cells

Eligibility Criteria

• Age: 2 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Immune Cell, Inc.: lead
• Weifang People's Hospital: collaborator

Study Sites (1)

Weifang People's Hospital

Weifang, Shandong, 261000, China

RECRUITING

MeSH Terms

Conditions

Leukemia, B-Cell; Lymphoma, B-Cell

Interventions

Biological Products

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin; Lymphoma

Intervention Hierarchy (Ancestors)

Complex Mixtures

Central Study Contacts

Xiulian Sun, MD.,Ph.D

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 6, 2017
• First Posted: December 27, 2017
• Study Start: March 1, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2025
• Last Updated: December 27, 2017

Record last verified: 2017-12

Locations

CN (1)