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

Acute Lymphocytic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04004637
• Other study ID #: PG-CART-007-001
• Status: Recruiting
• Phase: Phase 1
• Start date: August 25, 2019
• Est. completion date: June 1, 2021

Study information

• Verified date: September 2020
• Source: PersonGen BioTherapeutics (Suzhou) Co., Ltd.
• Contact: Mingzhi Zhang, Doctor
• Phone: +8613838565629
• Email: mingzhi_zhang[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Lymphoma
• Lymphoma, Non-Hodgkin
• Lymphoma, T-Cell
• NK/T Cell Lymphoma
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• T-lymphoblastic Lymphoma

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (2)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of the dose limiting toxicity (DLT)	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.	Time Frame: 4 weeks after CAR T cell infusion
Secondary	In vivo persistence/expansion of infused CAR T cell	Detection of infused CAR T cell in the peripheral blood.	Up to 2 years
Secondary	Determine the effects of CART-CD7 infusion on T cells and CD7 expression in vivo.		Up to 2 years
Secondary	Overall Response Rate (ORR)		4 weeks after CAR T cell infusion
Secondary	Overall Survival		Up to 2 years
Secondary	Disease-free survival		Up to 2 years