A Phase I, Multicenter study to evaluate the safety, tolerability, and Efficacy of LCAR-T2C CAR-T cells in relapsed or refractory CD4+T Lymphocyte Tumor Patients.
This is an open, dose escalation/dose extension study of LCAR-T2C CAR-T cells administrered to patients with T lymphocyte tumor. The aim of the study is to evaluate the safety, tolerability, and efficacy of LCAR-T2C CAR-T cells. The auto-CAR-T cells will be infused in single-dose.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
CD4-directed CAR-T cells administered with lymphodepletion, and to obtain the preliminary efficacy results in subjects who have been diagnosed with relapsed or refractory CD4 positive T lymphocyte tumor
Oncology Department,The First Affiliated Hospital of USTC west district
Hefei, Anhui, China
Hematological Department, People's Hospital of Jiangsu Province
Nanjing, Jiangsu, China
Hematological Department,The First Affiliated Hospital of the Air Force Medical University
Xi’an, Shanxi, China
Dose limiting toxicity (DLT)
DLT assessed by NCI-CTCAE 5.0
Time frame: 30 days post infusion
Adverse events
Incidence and severity of adverse events as assessed by NCI-CTCAE 5.0
Time frame: 90 days post infusion
Recommended Phase II dose (RP2D)
RP2D established through ATD+BOIN design and the DLTs occurring following CAR T-cell infusion
Time frame: 30 days post infusion
Pharmacokinetics
PK CAR positive T cells in peripheral blood, PK CAR transgene levels in peripheral blood, PK CAR positive T cells in bone marrow and PK CAR transgene levels in bone marrow.
Time frame: through study completion, 2 years after infusion of the last subject
Anti-drug antibody
Anti-drug antibody (ADA) will be conducted on blood sample for immune response analyses.
Time frame: through study completion, 2 years after infusion of the last subject
Overall response rate (ORR) after administration
Time frame: through study completion, 2 years after infusion of the last subject
Time to Response (TTR) after administration
Time frame: through study completion, 2 years after infusion of the last subject
Duration of remission (DOR) after administration
Time frame: through study completion, 2 years after infusion of the last subject
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Progress Free Survival (PFS) after administration
Time frame: through study completion, 2 years after infusion of the last subject
Over Survival (OS) after administration
Time frame: through study completion, 2 years after infusion of the last subject