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

Sponsor
Immune Cell, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03383952
Collaborator
Weifang People's Hospital (Other)
20
Enrollment
1
Location
1
Arm
106
Anticipated Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: ICAR19 CAR-T cells
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I Trial of CD19 Targeted ICAR19 T Cells in Patients With CD19+ Leukemia and Lymphoma.
Actual Study Start Date :
Mar 1, 2017
Anticipated Primary Completion Date :
Dec 31, 2020
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
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.

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.
Other Names:
  • Biological drug

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Weifang People's Hospital Weifang Shandong China 261000

    Sponsors and Collaborators

    • Immune Cell, Inc.
    • Weifang People's Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xiulian Sun, Principal Investigator, Immune Cell, Inc.
    ClinicalTrials.gov Identifier:
    NCT03383952
    Other Study ID Numbers:
    • CD19 Targeted CAR-T
    First Posted:
    Dec 27, 2017
    Last Update Posted:
    Dec 27, 2017
    Last Verified:
    Dec 1, 2017
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lymphoma
    Leukemia
    Leukemia, B-Cell
    Leukemia, Lymphocytic, Chronic, B-Cell

    Study Results

    No Results Posted as of Dec 27, 2017