This is a phase I, interventional, single arm, open label, clinical study to evaluate the safety and tolerability of CD5 CAR-T cells in refractory/relapsed CD5+ T-ALL patients who have no available curative treatment options.
T-acute lymphoblast leukemia (T-ALL) is a neoplastic lymphoid leukemia characterized by the proliferation of immature precursor T cells. The combined chemotherapy has significantly improved the prognosis of T-acute lymphoblast leukemia/lymphoma. However, once the disease appears to be relapsed/refractory, there is limited treatment options, and the overall prognosis is extremely poor. Therefore, exploring safe and effective treatments is a critical unmet medical need. The patients will receive infusion of CAR T-cells targeting CD5 to examine the safety and, possibly the efficacy of CD5 CAR T-Cells in CD5+ relapsed or refractory acute leukemia.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
CD5 CAR-T will be administered by I.V. infusion.
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGSafety: Incidence and severity of adverse events
To evaluate the possible adverse events occurred within the first one month following CD5 CAR-T infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity.
Time frame: First 1 month post CAR-T cells infusion
Efficacy: Remission Rate
Remission Rate including complete remission(CR)、CR with incomplete blood count recovery(CRi)、partial remission(PR), No remission(NR), overall remission (OR).
Time frame: 1 months post CAR-T cells infusion
Best overall response (BOR)
Best overall response (BOR) of complete remission (CR) or CR with incomplete blood count recovery (CRi) within 1 months after CD5 CAR-T infusion.
Time frame: 1 months
Duration of remission (DoR)
Duration of remission (DoR) within 1 year following CD5 CAR-T infusion (DoR is defined as the duration from the date when the response criteria of CR or CRi is first met to the date of relapse or death due to ALL).
Time frame: 1 year
Event free survival within 1 year
Event free survival (EFS) within 1 year (EFS is defined as the time from start of the first infusion to the earliest of death from any cause or relapse).
Time frame: 1 year
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