The primary purpose of this study is to determine the safety and efficacy of novel autologous CAR-T cells in patients with hematopoietic and lymphoid malignancies.
Chimeric antigen receptor (CAR)-modified 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, efficacy, pharmacokinetic, and pharmacodynamic of the CAR-T cells will be assessed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
CAR-T cells will be infused intravenously.
Administered according to package insert
Administered according to package insert
Shanghai Pudong Hospital, Fudan University Affiliated Pudong Medical Center
Shanghai, Shanghai Municipality, China
TEAEs
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
Duration of Overall Response (DOR)
Time from documentation of disease response to disease progression.
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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