This is a single-arm, open label, dose escalation, phase I study of EXP039 in adults with relapsed/refractory B-cell Non-Hodgkin's Lymphoma.
Condition of disease:B cell Non-Hodgkin's Lymphoma Intervention/treatment: Biological/Vaccine: CD19/CD20-direct CAR-T cells. phase: phase 1
This is a single-arm, open label, "3+3" dose escalation, phase I study to evaluate the safety and preliminary efficacy of EXP039 in adults with relapsed/refractory B-cell Non-Hodgkin's Lymphoma. 10 patients are planned to be enrolled.
Following consent, enrolled subjects will undergo a leukapheresis procedure to collect autologous mononuclear cells for manufacture of EXP039. Following manufacture of the drug product, subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide prior to EXP039 infusion. All subjects who have received EXP039 infusion will be followed for up to 12 months.
| Condition | B-Cell Lymphoma, Lymphoma, B-Cell, Lymphoma, B-Cell |
|---|---|
| Treatment | CD19/CD20-directed CAR-T cells |
| Clinical Study Identifier | NCT04693676 |
| Sponsor | First Affiliated Hospital of Zhejiang University |
| Last Modified on | 2 February 2023 |
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