Clinical Study of U29 Injection (CD30-CART) in Patients With CD30-Positive Relapsed/Refractory Ly… (NCT07453446) | Clinical Trial Compass
WithdrawnPhase 1
Clinical Study of U29 Injection (CD30-CART) in Patients With CD30-Positive Relapsed/Refractory Lymphoma
Stopped: The main consideration is the allocation of company resources, We can only terminate this research.
China0Started 2025-03-04
Plain-language summary
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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Subjects must provide written informed consent and demonstrate good compliance with study procedures.
✓. Age between 18 and 70 years, inclusive; male or female.
✓. Histologically confirmed relapsed or refractory lymphoma (with priority for Hodgkin lymphoma, anaplastic large cell lymphoma, or other lymphoproliferative disorders), with CD30 expression confirmed by immunohistochemistry or flow cytometry (≥50% positive cells).
✓. Relapsed or refractory disease, defined as:
✓. Failure to achieve remission or disease progression after autologous hematopoietic stem cell transplantation (auto-HSCT); OR
✓. Failure of at least two prior lines of systemic chemotherapy; OR
✓. Ineligibility for auto-HSCT due to:
✓. Chemotherapy resistance (failure to achieve CR or PR after salvage chemotherapy);
Exclusion criteria
✕. History of another malignancy, except for malignancies in complete remission for \> 3 years or carcinoma in situ.
✕. Lymphoma infiltration of the cardiac atria or ventricles.
✕. Use of immunosuppressive agents or corticosteroids within 1 week prior to leukapheresis, unless the investigator determines that the impact on T cells is minimal.
✕
What they're measuring
1
Incidence of Dose-Limiting Toxicity (DLT) and Treatment-Emergent Adverse Events (TEAEs) Within 28 Days Post CAR-T Infusion
Timeframe: 28 days post CAR-T cell infusion (for DLT); up to 24 months post CAR-T cell infusion (for other safety assessments)
2
Objective Response Rate (ORR), as assessed by Investigators
✕. Bacterial, fungal, viral, mycoplasmal, or other type of infection that is judged by the investigator to be difficult to control.
✕. Previous or current central nervous system (CNS) disease unrelated to the current lymphoma, such as seizures, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any CNS-related autoimmune disease, unless judged by the investigator to be controllable.
✕. Any of the following within 12 months prior to signing informed consent: