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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|ClinicalTrials.gov Identifier: NCT04004637|
Recruitment Status : Recruiting
First Posted : July 2, 2019
Last Update Posted : September 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|T-lymphoblastic Lymphoma NK/T Cell Lymphoma Acute Lymphocytic Leukemia||Drug: CD7 CAR-T cells infusion||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||CD7 CAR-T Cells for Patients With Relapse/Refractory CD7+ NK/T Cell Lymphoma ,T-lymphoblastic Lymphoma and Acute Lymphocytic Leukemia|
|Actual Study Start Date :||August 25, 2019|
|Estimated Primary Completion Date :||June 1, 2021|
|Estimated Study Completion Date :||June 1, 2021|
|Experimental: CD7 CAR-T cells Infusion||
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.
- Identification of the dose limiting toxicity (DLT) [ Time Frame: 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.
- In vivo persistence/expansion of infused CAR T cell [ Time Frame: 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. [ Time Frame: Up to 2 years ]
- Overall Response Rate (ORR) [ Time Frame: 4 weeks after CAR T cell infusion ]
- Overall Survival [ Time Frame: Up to 2 years ]
- Disease-free survival [ Time Frame: Up to 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04004637
|Contact: Mingzhi Zhang, Doctoremail@example.com|
|First Affiliated Hospital of Zhengzhou University||Recruiting|
|Zhengzhou, Henan, China, 450000|
|Contact: Min Yao, Bachelor's +8618355313511 firstname.lastname@example.org|