Clincosm LogoSign in Get a demo

Anti-CD22 CAR-T Cell Therapy Targeting B Cell Malignancies

Sponsor
Affiliated Hospital to Academy of Military Medical Sciences (Other)
Overall Status
Recruiting
CT.gov ID
NCT03262298
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
60
Anticipated Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study will evaluate safety and efficacy of the CD22-targeted chimeric antigen receptor modified-T cell(CAR-T) cells in the treatment of B-cell Malignancies.

Condition or Disease Intervention/Treatment Phase
  • Biological: Anti-CD22-CAR-transduced T cells
 Phase 1/Phase 2

Detailed Description

Clinical success with chimeric antigen receptor (CAR)- based immunotherapy for leukemia has been accompanied by the associated finding that antigen-escape variants of the disease are responsible for relapse. Despite anti-CD19 CAR-T exhibited the ability to re-induce remissions for many patients with relapsed and refractory B cell malignancies, a part of those patients will relapse with CD19-negative malignancies. CD22 is a type I transmembrane protein expressed on most mature B lymphocyte in the B cell malignancies，and plays a significant role in signal transduction pathway. The investigators design and conduct this trial to test the safety and effectiveness of CD22-targeted CAR-T.

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:
Anti-CD22 Chimeric Antigen Receptor (CAR)-Modified T Cell Therapy Targeting CD22 in Treating Patients With B Cell Malignancies
Actual Study Start Date :
Aug 20, 2017
Anticipated Primary Completion Date :
Aug 20, 2021
Anticipated Study Completion Date :
Aug 20, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: anti-CD22 CAR-T

Patients will receive a full dose CART infusion at day 0.

Biological: Anti-CD22-CAR-transduced T cells
a single dose of Anti-CD22-CAR-transduced T cells will be infusion after preconditioning.
Other Names:
  • anti-CD22 CART, CART22

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of adverse events related to treatment as assessed by NCI CTCAE version 4.03 [2 years]

    Secondary Outcome Measures

    1. Overall Complete Remission Rate (ORR) [2 years]

    2. Disease response(CR, CRi) [2 years]

    3. CART cells persistence in vivo [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Age: 18-65 years

    2. Patients with Cluster of Differentiation 22(CD22) positive B cell malignancies as confirmed by flow cytometry

    3. Refractory or relapsed B cell-acute lymphoblastic leukemia

    4. No available curative treatment options (such as hematopoietic stem cell transplantation)

    5. Stage III-IV disease

    6. Creatinine < 2.5 mg/dl

    7. Aspartate transaminase-alanine transaminase ratio < 3x normal

    8. Bilirubin < 2.0 mg/dl

    9. Karnofsky performance status >= 60

    10. Expected survival time > 3 months

    11. Adequate venous access for apheresis

    12. Ability to understand and provide informed consent

    Exclusion Criteria:

    1. Pregnant or lactating women

    2. Patients requiring T cell immunosuppressive therapy

    3. Active central nervous system leukemia

    4. Any concurrent active malignancies

    5. Patients with a history of a seizure disorder or cardiac disorder

    6. Previous treatment with any immunotherapy products

    7. Patients with human immunodeficiency virus, hepatitis B or C infection

    8. Uncontrolled active infection

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fengtai District Beijing Beijing China 100071

    Sponsors and Collaborators

    • Affiliated Hospital to Academy of Military Medical Sciences

    Investigators

    • Principal Investigator: Liangding Chen, M.D., Affiliated Hospital to Academy of Military Medical Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Affiliated Hospital to Academy of Military Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT03262298
    Other Study ID Numbers:
    • 307-B-22-CAR-T
    First Posted:
    Aug 25, 2017
    Last Update Posted:
    Feb 9, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Affiliated Hospital to Academy of Military Medical Sciences
    CD22
    CAR-T
    Leukemia
    Lymphoma
    Additional relevant MeSH terms:
    Leukemia

    Study Results

    No Results Posted as of Feb 9, 2021