To evaluate the safety and efficacy of autologous hematopoietic stem cell transfer (ASCT) combined with CD7-CART in the treatment of CD7+ TCL
With the subject's consent and having signed the informed consent form, willing and capable of adhering to the planned visits, study treatment, laboratory tests and other trial procedures;
Age 18 to 65 years old, both male and female;
Confirmed as T-cell non-Hodgkin's lymphoma type (including T-lymphoblastic lymphoma/leukemia) according to the World Health Organization's classification of hematopoietic and lymphoid tissue tumors (2022), and meeting one of the following three conditions: 1) Newly diagnosed with high-risk factors, such as Ann Arbor stage III/IV, large mass, bone marrow invasion, central nervous system (CNS) invasion, ETP phenotype, RAS activating mutation, TP53 deletion/mutation, etc., as assessed by the investigator; 2) Not achieving PR or better response after induction and consolidation therapy; 3) Patients not considered for allogeneic hematopoietic stem cell transplantation;
Confirmed as tumor cells expressing CD7 by histopathology and/or cytology at the time of screening;
History of allergy to any of the components in the cell product;
Severe cardiac disease, including but not limited to: Myocardial infarction, cardiac angioplasty, or stenting within 6 months prior to signing the ICF; unstable angina; severe cardiac arrhythmias; History of severe non-ischemic cardiomyopathy; Congestive heart failure (New York Heart Association [NYHA] Class III or IV), NYHA score listed in Appendix II
Have a history of autologous/allogeneic hematopoietic stem cell transplantation;
stroke or seizure within 6 months prior to signing the ICF;
Single group
ASCT+CD7-CART
DrugIntravenous infusion of CD7-CART 3 days after ASCT
PFS rate at 1 year after ASCT conbined with CD7-CART
Incidence and Severity of Adverse Events after ASCT conbined with CD7-CART
Refer to irAE grading standard
Duration of Response (DOR)
Time from first response evaluated by investigator to disease progression or death from any cause
Progression-free Survival (PFS)
MRD negetive rate
Time to Response (TTR)
Time from CD7-CART infusion to first documentation of response evaluated by investigators
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Institute of Hematology & Blood Diseases Hospital, China
Lead sponsor
Hebei Taihe Chunyu Biotechnology Co., Ltd
Collaborator
