CD7 CAR-T Cells for Patients With R/R CD7+ NK/T Cell Lymphoma,T-lymphoblastic Lymphoma and Acute Lymphocytic Leukemia

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Brief Title

CD7 CAR-T Cells for Patients With R/R CD7+ NK/T Cell Lymphoma,T-lymphoblastic Lymphoma and Acute Lymphocytic Leukemia

Official Title

CD7 CAR-T Cells for Patients With Relapse/Refractory CD7+ NK/T Cell Lymphoma ,T-lymphoblastic Lymphoma and Acute Lymphocytic Leukemia

Brief Summary

      This study is designed to explore the safety and efficacy of CD7 CAR-T Cells for patients
      with relapse/refractory CD7+ NK/T cell lymphoma ,T-lymphoblastic lymphoma and Acute
      Lymphocytic Leukemia. And to evaluate the pharmacokinetics of CD7 CAR-T cells in patients.
    


Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Identification of the dose limiting toxicity (DLT)

Secondary Outcome

 In vivo persistence/expansion of infused CAR T cell

Condition

T-lymphoblastic Lymphoma

Intervention

CD7 CAR-T cells infusion

Study Arms / Comparison Groups

 CD7 CAR-T cells Infusion
Description:  

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

10

Start Date

August 25, 2019

Completion Date

June 1, 2021

Primary Completion Date

June 1, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  1. Aged 7 to 70 years.

             2. The expected survival period is more than 12 weeks.

             3. ECOG: 0-2.

             4. Male and female subjects with CD7+ NK/T cell lymphoma ,T-lymphoblastic lymphoma and
             Acute Lymphocytic Leukemia in patients with no available curative treatment options
             will be enrolled:

               1. Not achieved PR after the standard first-line treatment for at least 4 courses.

               2. Relapse or progression after standardized treatment.

               3. Patients With NK/T Cell Lymphoma or T-lymphoblastic Lymphoma need to have at
                  least 1 tumor lesions can be evaluated.

             5. Cardiac left ventricle ejection fraction ≥40%.

             6. Serum creatinine≤1.5 ULN; oxygen saturation of blood >91%.

             7. Total bilirubin≤1.5×ULN; Serum ALT and AST≤2.5 ULN.

             8. Able to understand this study and have signed informed consent.

        Exclusion Criteria:

          -  1. Patients with graft-versus-host disease (GVHD) or who need to use immunosuppressive
             drugs.

             2. Patients with malignant tumors other than NK/T cell lymphoma , T-lymphoblastic
             lymphoma and Acute Lymphocytic Leukemia within 5 years prior to screening, in addition
             to adequately treated cervical carcinoma in situ, basal or squamous cell skin cancer,
             local prostate after radical surgery, breast ductal carcinoma in situ after cancer and
             radical surgery.

             3. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive
             and peripheral blood hepatitis B virus (HBV) DNA titer detection is not within the
             normal range; hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis
             C Viral (HCV) RNA positive; human immunodeficiency virus (HIV) antibody positive;
             cytomegalovirus (CMV) DNA positive; syphilis positive.

             4. Severe heart disease: including but not limited to unstable angina pectoris,
             myocardial infarction (within 6 months prior to screening), congestive heart failure
             (New York Heart Association [NYHA] classification ≥ III), severe arrhythmia.

             5. Unstable systemic diseases judged by investigator, including but not limited to
             severe liver, kidney or metabolic diseases needing medical treatment.

             6. Active or uncontrollable infections (except for mild genitourinary infections and
             upper respiratory tract infections) that require systemic treatment within 7 days
             prior to screening; 7. Women who are pregnant or breastfeeding, female subject who
             plans to have a pregnancy within 1 year after cell infusion, and male subject who
             plans to have a pregnancy within 1 year after cell infusion.

             8. Subject who have received CAR-T treatment or other genetically modified cell
             therapy before screening; 9. Subjects who are receiving systemic steroid therapy
             within 7 days prior to screening or who require long-term systemic steroid therapy
             judged by investigator (except for inhaled or topical use); 10. Participated in other
             clinical studies within 3 months prior to screening. 11. Patients with active CNS
             involvement by malignancy. 12. Not suitable for cell preparation. 13. Researchers
             consider it inappropriate to participate in the trial.
      

Gender

All

Ages

7 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

, +8613838565629, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT04004637

Organization ID

PG-CART-007-001


Responsible Party

Sponsor

Study Sponsor

PersonGen BioTherapeutics (Suzhou) Co., Ltd.

Collaborators

 The First Affiliated Hospital of Zhengzhou University

Study Sponsor

, , 


Verification Date

September 2020