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CD30 Targeted CAR-T in Treating CD30-Expressing Lymphomas

Sponsor
Immune Cell, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03383965
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

CAR-T cells have been validated effective in treating CD19 positive B cell lymphoma. Other lymphomas like Hodgkin's lymphoma and anaplastic large cell lymphoma are CD30 positive. In this study, a newly CD30 targeted CART therapy ICAR30 is designed to specifically kill those CD30 expressing malignancies including Hodgkin's lymphoma and CD30+ anaplastic large cell lymphoma. The subjects will receive several doses of autologous ICAR30 T cells infusion and then the safety, treating effects and lasting period of these cells in vivo will be evaluated.

Condition or Disease Intervention/Treatment Phase
  • Biological: ICAR30 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)
Masking Description:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Clinical Study of CD30 Targeted CAR-T in Treating CD30-Expressing Lymphomas
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: ICAR30 T cells

anti-CD30 CAR-T cells. Patients receive ICAR30 T cells infusion.

Biological: ICAR30 T cells
T cells were isolated from peripheral blood from patients enrolled. T cells were transduced with lentivirus bearing anti-CD30 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 ICAR30 T cells [2 years]

      To assess the adverse events of ICAR30 T cells infusion in patients with Hodgkin's lymphoma and CD30+ anaplastic large cell lymphoma.

    Secondary Outcome Measures

    1. Measure the anti-tumor effect of ICAR30 T cells [3 years]

      To assess the anti-tumor effect of ICAR30 T cells infusion in patients with Hodgkin's lymphoma and CD30+ anaplastic large cell lymphoma.

    2. Measure the survival time of ICAR30 T cells in vivo [5 years]

      To measure the survival time of ICAR30 T cells in vivo, extra blood will be drawn from patients receive ICAR30 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:

    Hodgkin's lymphoma, anaplastic large cell lymphoma and other CD30 positive malignancies, relapsed or refractory:

    • Karnofsky or Lansky score >50;

    • Expected survival>12 weeks;

    • Hgb > 8.0;

    • 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 fold normal;

    • Patients must sign an informed consent.

    Exclusion Criteria:

    • Pregnant or lactating;

    • Uncontrolled active infection including hepatitis B or C;

    • HIV positive;

    • Active clinically significant CNS dysfunction;

    • Current use of systemic steroids;

    • Heterogenous lymphocyte treatments within recent 6 months;

    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:
    NCT03383965
    Other Study ID Numbers:
    • CD30-targeting CAR-T
    First Posted:
    Dec 27, 2017
    Last Update Posted:
    Dec 27, 2017
    Last Verified:
    Mar 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, Large-Cell, Anaplastic

    Study Results

    No Results Posted as of Dec 27, 2017