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

Phase 1

• Conditions: Acute Lymphocytic Leukemia; T-lymphoblastic Lymphoma; NK/T Cell Lymphoma
• Interventions: Drug: CD7 CAR-T cells infusion

• Registration Number: NCT04004637
• Lead Sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-28
• Study First Submitted QC: 2019-06-28
• Study First Posted: 2019-07-02
• Study Start: 2019-08-25
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-25
• Last Update Posted: 2020-09-28
• Primary Completion: 2021-06-01
• Study Completion: 2021-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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:

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

  6. Relapse or progression after standardized treatment.

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

  8. Cardiac left ventricle ejection fraction ≥40%.

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

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

  11. 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.

  7. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CD7 CAR-T cells Infusion	CD7 CAR-T cells infusion	-

Primary Outcome Measures

Name	Time	Method
Identification of the dose limiting toxicity (DLT)	Time Frame: 4 weeks after CAR T cell infusion	Toxicity will be assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) scale, version 5 and the number of patients experiencing DLT will be evaluated.

Secondary Outcome Measures

Name	Time	Method
Overall Survival	Up to 2 years
In vivo persistence/expansion of infused CAR T cell	Up to 2 years	Detection of infused CAR T cell in the peripheral blood.
Determine the effects of CART-CD7 infusion on T cells and CD7 expression in vivo.	Up to 2 years
Overall Response Rate (ORR)	4 weeks after CAR T cell infusion
Disease-free survival	Up to 2 years

Trial Locations

Locations (1)

First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China