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Adult B-ALL Treated by CART Cell Bridging Allogeneic Hematopoietic Stem Cell Transplantation

Sponsor
Hebei Senlang Biotechnology Inc., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04626726
Collaborator
(none)
50
Enrollment
1
Location
1
Arm
37.9
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is an open, single-arm, phase I/phase II clinical study to evaluate efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) in the treatment of Relapsed Refractory (R/R) adult acute lymphoblastic leukemia bridging allogeneic hematopoietic stem cell transplantation.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

Detailed Description

This trial openly recruited 50 patients into the group and were given CAR-T treatment. Patients participating in clinical trials will be tested and evaluated in terms of treatment safety, efficacy, and response duration. As assessed by clinicians, adult B-ALL patients who meet the enrollment criteria, after adequate communication, the patient or family members voluntarily join the clinical study, and are willing to bridge allogeneic hematopoiesis within 3 months after enrollment using CAR-T therapy。

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Clinical Trial to Explore the Safety, Efficacy, and Remission Phase of CAR-T Cell in the Treatment of Adult Relapsed Refractory (R/R) Acute Lymphoblastic Leukemia Bridging Allogeneic Hematopoietic Stem Cell Transplantation
Actual Study Start Date :
Apr 1, 2020
Anticipated Primary Completion Date :
May 30, 2023
Anticipated Study Completion Date :
May 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Volunteers

The patient voluntarily signs the informed consent, and the patient meets the entry criteria to diagnose patients with acute B lymphocytic leukemia expressing specific target antigens

Drug: CD19 CAR-T
CD19 CAR-T infusion for patients with CD19 positive tumor cells
Other Names:
  • Senl_19

    • Drug: CD22 CAR-T
    CD22 CAR-T infusion for patients with CD22 positive tumor cells
    Other Names:
  • Senl_22

    • Drug: CD19+CD22 CAR-T
    CD19+CD22 CAR-T infusion for patients with CD19 positive and CD22 positive tumor cells
    Other Names:
  • Senl_19+22

    • Drug: Fludarabine
    25mg/㎡ for D-4、D-3 and D-2
    Other Names:
  • fiu

    • Drug: Cyclophosphamide
    500mg/㎡ for D-3 and D-2
    Other Names:
  • ctx

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants with Severe/Adverse Events as a Measure of Safety [28 days]

      Number of Participants with Severe/Adverse Events as a Measure of Safety

    2. Copies numbers of CAR in peripheral blood(PB) and/or bone marrow(BM) [24 months]

      Copies numbers of CAR in peripheral blood(PB) and/or bone marrow(BM)

    Secondary Outcome Measures

    1. Objective response rate of complete remission and partial remission [24 months]

      Objective response rate of complete remission and partial remission

    2. Overall survival time [24 months]

      Overall survival time

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    14 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Be diagnosed a kind of Relapsed or Refractory Haematopoietic and Lymphoid
    Malignancies:

    1. ECOG score≤2;

    2. To be aged 1 to 65 years;

    3. More than a month lifetime from the consent signing date.

    Exclusion Criteria:

    1. Serious cardiac insufficiency, left ventricular ejection fraction<50%;

    2. Has a history of severe pulmonary function damaging;

    3. Merging other progressing malignant tumor;

    4. Merging uncontrolled infection;

    5. Merging the metabolic diseases (except diabetes);

    6. Merging severe autoimmune diseases or immunodeficiency disease;

    7. Patients with active hepatitis B or hepatitis C;

    8. Patients with HIV infection;

    9. Has a history of serious allergies on Biological products (including antibiotics);

    10. Has acute GvHD on allogeneic hematopoietic stem cell transplantation patients after stopping immunosuppressants a month;

    11. Pregnancy or lactation women;

    12. Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 No.2 Hospital of Hebei Medical University Shijiazhuang Hebei China 050000

    Sponsors and Collaborators

    • Hebei Senlang Biotechnology Inc., Ltd.

    Investigators

    • Principal Investigator: Jianmin Luo, PhD&MD, The Second Hospital of Hebei Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hebei Senlang Biotechnology Inc., Ltd.
    ClinicalTrials.gov Identifier:
    NCT04626726
    Other Study ID Numbers:
    • CAR-T for adult B-ALL
    First Posted:
    Nov 13, 2020
    Last Update Posted:
    Nov 13, 2020
    Last Verified:
    Nov 1, 2020
    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:
    Leukemia
    Precursor Cell Lymphoblastic Leukemia-Lymphoma
    Leukemia, Lymphoid
    Cyclophosphamide
    Fludarabine

    Study Results

    No Results Posted as of Nov 13, 2020