This is a single-center, open-label study conducted in subjects with relapsed or refractory CD30-positive lymphoma, with priority given to Hodgkin lymphoma and anaplastic large cell lymphoma.
The primary purpose of this study is to evaluate the preliminary efficacy, safety, and tolerability of CD30-targeted CAR-T cell therapy in participants with CD30-positive relapsed or refractory lymphoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Lymphodepletion preconditioning is required prior to CAR-T cell therapy. Lymphodepletion will be performed using a regimen of cyclophosphamide (250-500 mg/m²) and fludarabine (25-30 mg/m²), each administered for 3 consecutive days.
Hebei Yanda Lu Daopei Hospital
Sanhe, China
Incidence of Dose-Limiting Toxicity (DLT) and Treatment-Emergent Adverse Events (TEAEs) Within 28 Days Post CAR-T Infusion
Incidence, type, frequency, and severity of DLT within 28 days post CAR-T infusion; incidence of TEAEs, clinically significant abnormalities in laboratory tests, vital signs, electrocardiogram (ECG), and echocardiography results after CAR-T infusion, graded by CTCAE v5.0.
Time frame: 28 days post CAR-T cell infusion (for DLT); up to 24 months post CAR-T cell infusion (for other safety assessments)
Objective Response Rate (ORR), as assessed by Investigators
The Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Remission (CR) or Partial Remission(PR)
Time frame: 2 years post CAR T cell infusion
Duration of response (DOR)
Duration of response (DOR) is defined as the time from the first documented objective response to the first documented disease progression or death.
Time frame: 2 years post CAR T cell infusion
Overall survival (OS)
Overall Survival (OS) was defined as the time from the date of first infusion of U01 to the date of death due to any cause.
Time frame: 2 years post CAR T cell infusion
Progression-free survival (PFS)
Progression-free survival (PFS) was defined as the time from the date of infusion to the earliest date of the first objective documentation of progressive disease (PD) or death due to any cause.
Time frame: 2 years post CAR T cell infusion
Pharmacokinetics of U29
Time at the maximal concentration(Tmax)
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Time frame: 2 years post CAR T cell infusion
Pharmacokinetics of U29
Area under the concentration-time curve(AUC)
Time frame: 2 years post CAR T cell infusion
Pharmacokinetics of U29
The maximal concentration of peripheral blood (Cmax)
Time frame: 2 years post CAR T cell infusion
Pharmacodynamics of U29
Concentration levels of CAR-T-related serum cytokines such as IL-6, IFN γ, ferritin and CRP at each time point
Time frame: 2 years post CAR T cell infusion