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

• Status: Recruiting
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd.
• Collaborator: The First Affiliated Hospital of Zhengzhou University

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.