Anti-TRBC1 CAR-T Cell Therapy in Patients With TRBC1 Positive T Cell Malignancies

Brief Title

Anti-TRBC1 CAR-T Cell Therapy in Patients With TRBC1 Positive T Cell Malignancies

Official Title

The Safety and Clinical Efficacy of Human TRBC1 CAR-T Cell Therapy for Patients With Relapsed/Refractory TRBC1 Positive T Cell Hematological Maliganacies

Brief Summary

      The purpose of this study is to evaluate the safety and efficacy of CAR T cell treatment
      targeting TRBC1 in patients with relapsed or refractory TRBC1 positive T-cell hematological
      maliganacies
    


Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Safety and Tolerability

Secondary Outcome

 CAR-T cell expansion and persistence

Condition

Peripheral T Cell Lymphoma

Intervention

anti-TRBC1 CAR-T cell therapy

Study Arms / Comparison Groups

 anti-TRBC1 CAR-T cell
Description:  Administration with anti-TRBC1 CAR-T cells in the relapsed/refractory T cell hematological malignancy patients.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

9

Start Date

March 31, 2021

Completion Date

March 2024

Primary Completion Date

March 2023

Eligibility Criteria

        Inclusion Criteria:

        (1)18 to 70 Years Old, Male and female; (2) Expected survival > 12 weeks; (3) ECOG score
        0-2; (4) Confirmed diagnosis of acute T cell leukemia and screened for TRBC1 positive,
        including following conditions:

          1. Patients who do not get a CR with ≥2 prior lines of therapy

          2. Those who achieves CR, but have a early relapse(<12months),or a late relapse
             (>=12months) failing to acheive a CR after 1 line salvage chemotherapy

          3. For any Patiens failed ASCT/allo-SCT (5) Relapsed and refractory patients with
             diagnosis of T cell lymphoma have had≥2 prior lines of therapy,including:

        a. Peripheral T cell lymphoma NOS, or b. Angioimmunoblastic T cell lymphoma, or c.
        Anaplastic large cell lymphoma (6) Confirmed T lymphoblatic lymphoma

          1. Patients who do not get a CR with ≥2 prior lines of therapy

          2. Relapsed patients failing to acheive a CR after 1 line salvage chemotherapy

          3. For any Patiens failed ASCT/allo-SCT (7) The venous access required for collection can
             be established and mononuclear cell collection can be determined by the investigators;
             (8) Liver, kidney and cardiopulmonary functions meet the following requirements:

        a. Ccr≥60mL/min(Cockcroft Gault) b. Left ventricular ejection fraction >50%; c. Baseline
        oxygen saturation>92%; d. Total bilirubin ≤ 1.5×ULN; e. ALT and AST ≤ 3×ULN; (9) Able to
        understand and sign the In

        Exclusion Criteria:

          1. Malignant tumors other than acute lymphoblastic leukemia within 5 years prior to
             screening, in addition to adequately treated cervical carcinoma in situ, basal cell or
             squamous cell skin cancer, localized prostate cancer after radical resection, and
             ductal carcinoma in situ after radical resection;

          2. Uncontrolled infection;patients with positive HBsAg or HBcAb and peripheral blood HBV
             DNA titer detection ≥ 1 × 10^2 copy number / L; HCV antibody positive and peripheral
             blood HCV RNA positive; HIV antibody positive; CMV DNA positive; syphilis positive;

          3. Any instability of systemic disease, including but not limited to unstable angina,
             cerebrovascular accident, or transient cerebral ischemic (within 6 months prior to
             screening), myocardial infarction (within 6 months prior to screening), congestive
             heart failure (New York heart association (NYHA) classification ≥ III), need drug
             therapy of severe arrhythmia, liver, kidney, or metabolic disease;

          4. Any uncontrolled disease may affect entry

          5. Current or history of CNS involvement by malignancy.Known history or presence of
             clinically relevant central nervous system (CNS) pathology. Patients with a known
             history or prior diagnosis other immunologic or inflammatory disease affecting the CNS
             (such as epilepsy)

          6. Patients who are receiving systemic steroid treatment and requiring long-term systemic
             steroid treatment during the treatment as determined by the investigator before
             screening (except inhalation or topical use); And subjects treated with systemic
             steroids (except inhalation or topical use) within 72h prior to cell transfusion;

          7. Pregnant or lactating woman, and female subject who plans to have a pregnancy within 1
             year after cell transfusion, or male subject whose partner plans to have a pr egnancy
             within 1 year after cell transfusion;

          8. Active or uncontrollable infection requiring systemic therapy

          9. Received CAR-T treatment or other gene therapies before enrollment;

         10. Kown be allergic to anti-TRBC1 CAR-T cells or drugs(Fludarabine or Cyclophophamide)

         11. The investigators consider other conditions unsuitable for enrollment.

         12. Patients who may not be able to sign the Informed Consent due to disease,or who do not
             understand or unwillingness or inability to comply with research requirements
      

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT04828174

Organization ID

SHYSXY-202101-CART


Responsible Party

Principal Investigator

Study Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine


Study Sponsor

, , 


Verification Date

March 2021