The primary objective of this study is to evaluate the safety and clinical activity of anti-CD19 Chimeric Antigen Receptor T cells (KD-019 CAR-T)infusion in the treatment of relapsed/refractory B-cell Lymphoma and B-cell acute lymphoblastic leukemia (B-ALL).
The investigators designed an KD-019 Chimeric Antigen Receptor(CAR) with FMC63 single-chain antibody fragment (Scfv). This CAR has a CD8 hinge and transmembrane domains and a 4-1BB costimulatory domain; T cells expressing this CAR release relatively low levels of cytokines. Subjects with relapsed/refractory CD19-positive B-cell Lymphoma and B-ALL can participate if all eligibility criteria are met. Subjects receive chemotherapy prior to the infusion of KD-019 CAR-T cells. After the infusion, subjects will accept follow-up for side effects and effect of KD-019 CAR-T cells by the sponsor. Study procedures may be performed while hospitalized.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Autologous genetically modified anti-CD19 CAR transduced T cells
Kunming Yan'an Hospital, Oncology Department
Kunming, Yunnan, China
RECRUITINGNumber of Participants with severe cytokine release syndrome(CRS) as a Measure of Safety and Tolerability.
The severe CRS post KD-019 CAR-T cells treatment will be evaluated and the maximum tolerated dose will be determined.
Time frame: 0 to 14 days post infusion
Copies numbers of CAR in peripheral blood (PB)
Copies numbers of CAR in peripheral blood (PB)
Time frame: 1 year post infusion
Overall survival
For all subjects, overall survival refers to the period from being included in the test group to death caused by any reason
Time frame: 2 years post infusion
Duration of Response after administration
Duration of Response after administration
Time frame: 2 years post infusion
Progress Free Survival after administration
Progress Free Survival after administration
Time frame: 2 years post infusion
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