A Study of EXP039 Treatment in Subjects With r/r NHL Subjects

  • STATUS
    Recruiting
  • participants needed
    10
  • sponsor
    First Affiliated Hospital of Zhejiang University
Updated on 30 November 2022

Summary

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

Description

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.

Details
Condition B-Cell Lymphoma, Lymphoma, B-Cell, Lymphoma, B-Cell
Treatment CD19/CD20-directed CAR-T cells
Clinical Study IdentifierNCT04693676
SponsorFirst Affiliated Hospital of Zhejiang University
Last Modified on30 November 2022

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