Acute leukemia is a malignant clonal disease of hematopoietic stem cells. At present, the treatment for acute leukemia is relatively limited, and it is still based on high-intensity chemotherapy drug therapy and hematopoietic stem cell transplantation. The prognosis of recurrent and refractory acute leukemia is poor, and there is a lack of effective treatment plan. CD7 is a specific target on the surface of T cells, and CD7 CAR-T is expected to provide a new therapeutic path for patients with relapsed refractory acute leukemia.This is an open, single-arm, single-center, prospective clinical study. The main objective of the clinical study is to evaluate the clinical safety and tolerability of CD7 CAR-T in the treatment of acute leukemia.
CD7 expression was determined by flow cytometry. After the target was determined, the subjects received the target dose of CD7 CAR-T from 1×105 to 1×108 /kg. Each subject will start with a low dose of 1×105/kg and if there are no significant side effects will be increased to the next dose until the maximum tolerated dose is reached. A variety of adverse events (including neurological events, hematological events, infections, and secondary tumors) will be collected from the time of infusion of CAR T cells to 24 months after infusion. To understand the complete response rate (CR) and partial response rate (PR) at 3 months; Recurrence rate, progression-free survival (PFS) and overall survival (OS) after 1 to 5 years of CD7 CAR-T reinfusion; The amount and duration of CD7 CAR-T in vivo.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Split intravenous infusion of CD7 CAR-T cells \[dose escalating infusion of (1-100)x10\^6 CD7 CAR-T cells/kg\]
The General Hospital of Western Theater Command
Chengdu, Sichuan, China
RECRUITINGNumber of Adverse Events
Adverse events are evaluated with CTCAE V4.03
Time frame: 12 months
Overall response rate (ORR)
ORR includes CR, CRi, MLFS and PR. Complete remission (CR)#Bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count \>1.0x 10\^9/L; platelet count \>100x10\^9/L. CR with incomplete hematologic recovery (CRi)#All CR criteria except for residual neutropenia (\<1.0x10\^9/L) or thrombocytopenia (\<100x10\^9/L). Morphologic leukemia-free state (MLFS): Bone marrow blasts \<5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required. Partial remission (PR): All hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%.
Time frame: 24 months
Duration of overall response (DOR)
Duration of overall response will be assessed from the CAR-T cell infusion to progression, death or last follow-up
Time frame: 24 months
Progression-free survival(PFS)
PFS will be assessed from the CAR-T cell infusion to progression, death or last follow-up.
Time frame: 24 months
Overall survival(OS)
OS will be assessed from the CAR-T cell infusion to death or last follow-up
Time frame: 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.