An open label, single arm Phase I study to evaluate the safety, tolerability, and pharmacokinetics of LUCAR-20S CAR-T cells in relapsed or refractory CD20+ diffuse large B-cell, follicular, mantle cell and small lymphocytic lymphoma.
This study is an open, dose escalation/dose regimen finding study to assess the safety and pharmacokinetics of donor-derived CD20-directed CAR-T cells administered with lymphodepletion, and to obtain the preliminary efficacy results in subjects who have been diagnosed with relapsed or refractory CD20 positive diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma or small lymphocytic lymphoma. The allo-CAR-T cells will be infused in single-dose.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
An Anti-CD20 Allogeneic CAR-T Cell Therapy in Patients with Relapsed/Refractory Diffuse Large B-Cell, Follicular, Mantle Cell or Small Lymphocytic Lymphoma
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,Beijing Boren Hospital
Beijing, 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
Concentration of Pharmacokinetics in blood
PK CAR positive T cells in peripheral blood, PK CAR transgene levels in peripheral blood
Time frame: through study completion, 2 years after infusion of the last subject
Concentration of Pharmacokinetics in bone marrow
PK CAR positive T cells in bone marrow, PK CAR transgene levels in bone marrow
Time frame: through study completion, 2 years after infusion of the last subject
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
Overall response rate (ORR) after administration
Antitumor efficacy by 2014 Lugano criteria
Time frame: 3 months post infusion
Time to Response (TTR) after administration
Antitumor efficacy by 2014 Lugano criteria
Time frame: 3 months post infusion
Duration of remission (DOR) after administration
Antitumor efficacy by 2014 Lugano criteria
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Time frame: through study completion, 2 years after infusion of the last subject
Progress Free Survival (PFS) after administration
Antitumor efficacy by 2014 Lugano criteria
Time frame: through study completion, 2 years after infusion of the last subject
Overall Survival (OS) after administration
Antitumor efficacy by 2014 Lugano criteria
Time frame: through study completion, 2 years after infusion of the last subject