The primary purpose of this study is to determine the safety and efficacy of novel autologous CAR-T cells in patients with relapsed/refractory hematological malignancies.
CAR-T cells targeted CD19 have demonstrated unprecedented successes. Besides CD19, many other molecules such as CD123, BCMA, and CD7 may be potential in developing the corresponding CAR-T cells to treat patients with hematopoietic and lymphoid malignancies. UTC Therapeutics Inc. have developed an efficient platform for constructing CAR-T cells that can remodel of tumor microenvironment and enhance the anti-tumor immune response and persistence of CAR-T cells. In this study, all eligible subjects will receive a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by investigational treatment, CAR-T cells. Safety and efficacy of the CAR-T cells will be assessed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
D0: CAR-T cells will be infused intravenously.
D-5 to D-3: Fludarabine (30 mg/m\^2/day) will be administered intravenously for 3 days.
D-5 to D-3: Cyclophosphamide (500 mg/m\^2/day) will be administered intravenously for 3 days.
The Affiliated People's Hospital of Ningbo University
Ningbo, Zhejiang, China
RECRUITINGTEAEs
Incidence and severity of Treatment Emergent Adverse Event.
Time frame: 4 weeks
TRAEs
Incidence and severity of Treatment Related Adverse Events.
Time frame: 4 weeks
AESIs
Incidence and severity of AEs of Special Interest.
Time frame: 4 weeks
Objective Response Rate (ORR) (PR+CR)
The proportion of patients with complete response(CR) or partial response(PR)
Time frame: 12 months
Progression-Free Survival (PFS)
PFS was defined as the time from CAR-T infusion to the date of disease progression or death from any cause. Participants not meeting the criteria for progression by the analysis data cutoff date were censored at their last evaluable disease assessment date.
Time frame: 12 months
Overall survival (OS)
OS was defined as the time from CAR-T infusion to the date of death. Participants who did not die by the analysis data cutoff date were censored at their last contact date.
Time frame: 12 months
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