This is an open-label, single arm study to evaluate the safety and tolerability of treatment with CT032 CAR-CD19 T in patients with relapsed and/or refractory non-Hodgkin's B cell lymphoma (R/R B-NHL).
This study is a single-arm, open label, phase I/II clinical trial to evaluate the safety, efficacy and cellular kinetics of CT032 CAR-CD19 T cells in patients with R/R B-NHL. The study is composed of two stages, Phase I stage is for dose escalation and recommendation of phase 2 dose, and Phase II stage is to verify the efficacy and safety of the dose proposed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
The CAR- CD19 T cells (study drug) used in this study are chimeric antigen receptor specifically expressing T cells targeting CD19. Fludarabine and Cyclophosphamide are used for lymphodepletion.
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China
Phase Ⅰ, Safety/Tolerability: Dose-limiting toxicity (DLT)
Dose-limiting toxicity (DLT)
Time frame: 28 days post administration of CAR-T cells
Phase Ⅰ, Safety/Tolerability: Maximum tolerated dose (MTD)
Maximum tolerated dose (MTD)
Time frame: 28 days post administration of CAR-T cells
Phase Ⅰ, Safety/Tolerability: Incidence and severity of Treatment emergent adverse events (TEAE)
Incidence and severity of Treatment emergent adverse events (TEAE)
Time frame: 28 days post administration of CAR-T cells
Phase Ⅰ, Safety/Tolerability: Incidence and severity of study treatment related AE
Incidence and severity of AE related to study treatment
Time frame: through 2 months post administration of CAR-T cells
Phase Ⅰ, Safety/Tolerability: Incidence and severity of AEs of special interest (cytokine release syndrome [CRS], CART-cell-related encephalopathy syndrome [CRES])
Incidence and severity of AEs of special interest (cytokine release syndrome \[CRS\], CART-cell-related encephalopathy syndrome \[CRES\])
Time frame: through 2 months post administration of CAR-T cells
Phase Ⅰ, Safety/Tolerability: Incidence and severity of Dose-limiting toxicity (DLT) of dose escalation experiment
Incidence and severity of Dose-limiting toxicity (DLT) of dose escalation experiment
Time frame: 28 days after infusion
Phase Ⅰ, Safety/Tolerability: Recommended Phase II Dose (RP2D)
Recommended Phase II Dose (RP2D)
Time frame: through 2 months post administration of CAR-T cells
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Phase Ⅱ, Efficacy: Overall Remission Rate (ORR)
Overall Remission Rate (ORR) (Partial remission and complete remission rate after infusion of CT032 CAR-CD19 T cells)
Time frame: through 6 months post administration of CAR-T cells
Phase Ⅰ, Safety/Tolerability: Incidence and severity of Treatment emergent adverse events (TEAE)
Incidence and severity of Treatment emergent adverse events (TEAE)
Time frame: through 24 months post administration of CAR-T cells
Phase Ⅰ, Safety/Tolerability: Incidence and severity of study treatment related AE
Incidence and severity of AE related to study treatment
Time frame: through 24 months post administration of CAR-T cells
Phase Ⅰ, Safety/Tolerability: Cytokine (IL-2, IL-6,IL-8,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by MSD and CBA method
Cytokine (IL-2, IL-6,IL-8,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by MSD and CBA method
Time frame: through 24 months post administration of CAR-T-cells
Phase Ⅰ: the number of copies of CAR-CD19 T cells in peripheral blood genomes by qPCR method and CAR-CD19 T cells by flow cytometry method
the number of copies of CAR-CD19 T cells in peripheral blood genomes by qPCR method and CAR-CD19 T cells by flow cytometry method
Time frame: through 24 months post administration of CAR-T cells
Phase Ⅰ, Efficacy: Overall Remission Rate (ORR)
Overall Remission Rate (ORR) (Partial remission and complete remission rate after infusion of CT032 CAR-CD19 T cells)
Time frame: through 24 months post administration of CAR-T cells
Phase Ⅱ, Efficacy: complete response (CR) rate
complete response (CR) rate
Time frame: through 24 months post administration of CAR-T cells
Phase Ⅱ, Efficacy: duration of response (DOR)
duration of response (DOR)
Time frame: through 24 months post administration of CAR-T cells
Phase Ⅱ, Efficacy: time to response (TTR)
time to response (TTR)
Time frame: through 24 months post administration of CAR-T cells
Phase Ⅱ, Efficacy: progression-free survival (PFS)
progression-free survival (PFS) time
Time frame: through 24 months post administration of CAR-T cells
Phase Ⅱ, Efficacy: overall survival (OS)
overall survival (OS) time
Time frame: through 24 months post administration of CAR-T cells
Phase Ⅱ, Safety/Tolerability: Incidence and severity of Treatment emergent adverse events (TEAE)
Incidence and severity of Treatment emergent adverse events (TEAE)
Time frame: through 24 months post administration of CAR-T cells
Incidence and severity of o study treatment related AE
Incidence and severity of AE related to study treatment
Time frame: through 24 months post administration of CAR-T cells
Phase Ⅱ, Safety/Tolerability: Incidence and severity of AEs of special interest (CRS, CRES)
Incidence and severity of AEs of special interest (CRS, CRES)
Time frame: through 24 months post administration of CAR-T cells
Phase Ⅱ, Safety/Tolerability: Cytokine (IL-2, IL-6,IL-8,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by MSD and CBA method
Cytokine (IL-2, IL-6,IL-8,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by MSD and CBA method
Time frame: through 24 months post administration of CAR-T cells
Phase Ⅱ: the number of copies of CAR-CD19 T cells in peripheral blood genomes by qPCR method and CAR-CD19 T cells by flow cytometry method
the number of copies of CAR-CD19 T cells in peripheral blood genomes by qPCR method and CAR-CD19 T cells by flow cytometry method
Time frame: through 24 months post administration of CAR-T cells