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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-25

Study Completion Date

2021-06-01

Brief Summary

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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.

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Detailed Description

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Conditions

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T-lymphoblastic Lymphoma NK/T Cell Lymphoma Acute Lymphocytic Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CD7 CAR-T cells Infusion

Group Type EXPERIMENTAL

CD7 CAR-T cells infusion

Intervention Type DRUG

Biological: CD7 CAR-T cells infusion. Pretreatment: patients enrolled in this study will receive cyclophosphamide or fludarabine plus cyclophosphamide. CD7 CAR-T cells infusion are allowed within 2 weeks after treatment.

CD7 CAR-T cells infusion: 30-60 minutes before infusion, H1 anti-histamine agents are applied (acetaminophen 30mg,po.; promethazine 25mg,i.v. ; diphenhydramine 0.5-1mg/kg, no more than 50mg.). Non-physiological doses of corticosteroids are not applied for patients during treatment or recovery unless a life-threatening emergency occurs. CD7 CAR-T cells are infused into patients for one or two times, the number of infused CD7 CAR-T cells are 0.5-5×10\^6/kg.

Interventions

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CD7 CAR-T cells infusion

Biological: CD7 CAR-T cells infusion. Pretreatment: patients enrolled in this study will receive cyclophosphamide or fludarabine plus cyclophosphamide. CD7 CAR-T cells infusion are allowed within 2 weeks after treatment.

CD7 CAR-T cells infusion: 30-60 minutes before infusion, H1 anti-histamine agents are applied (acetaminophen 30mg,po.; promethazine 25mg,i.v. ; diphenhydramine 0.5-1mg/kg, no more than 50mg.). Non-physiological doses of corticosteroids are not applied for patients during treatment or recovery unless a life-threatening emergency occurs. CD7 CAR-T cells are infused into patients for one or two times, the number of infused CD7 CAR-T cells are 0.5-5×10\^6/kg.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

7 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No