A Phase 1 interventional study of CD7 CAR-T cells infusion in T-lymphoblastic Lymphoma, NK/T Cell Lymphoma and Acute Lymphocytic Leukemia, sponsored by PersonGen BioTherapeutics (Suzhou) Co., Ltd.. Status unknown at 1 site in China. Open to participants aged 7 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-09-28.
Sponsored by PersonGen BioTherapeutics (Suzhou) Co., Ltd. · Phase 1, Interventional, and Treatment
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's planned enrollment of 10 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →PersonGen BioTherapeutics (Suzhou) Co., Ltd. is the lead sponsor of 43 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Aged 7 to 70 years.
Exclusion Criteria:
Patients with graft-versus-host disease (GVHD) or who need to use immunosuppressive drugs.
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)
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: Time Frame: 4 weeks after CAR T cell infusion
In vivo persistence/expansion of infused CAR T cell
Detection of infused CAR T cell in the peripheral blood.
Time frame: Up to 2 years
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
Plan to share: Undecided
This study is status unknown, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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PersonGen BioTherapeutics (Suzhou) Co., Ltd.