PhI/II IMPT-314 in Pts w/Relapsed or Refractory Aggressive B-Cell Non-Hodgkin Lymphoma

UCI Specialty Area: Cancer

Principal Investigator: Stefan Octavian Ciurea

Official Title: Phase I/II Multi-Center Study Evaluating the Safety and Efficacy of IMPT-314, a CD19/20 Bispecific Chimeric Antigen Receptor (CAR) T Cell Therapy in Participants with Relapsed or Refractory Aggressive B-Cell Non-Hodgkin Lymphoma

A Study On:

Non-Hodgkin's Lymphoma

Study Description

This is a Phase 1/2, multi-center, open-label study evaluating the safety and efficacy of IMPT-314, a bispecific chimeric antigen receptor (CAR) targeting cluster of differentiation (CD)19 and CD20 in participants with aggressive B-cell NHL. Three cohorts of participants will be enrolled: 1) CAR T naïve after at least two or more prior lines of treatment, 2) CAR T experienced and 3) refractory disease or relapse within one year of first line therapy.

Up to approximately 90 patients (30 per cohort) will be enrolled in dose finding Phase 1 part of the study, which will determine the recommended phase 2 dose.

Phase 2 will enroll up to approximately 60 additional participants (20 per cohort) to evaluate further the safety and efficacy of IMPT-314.

IMPT-314 treatment consists of a single infusion of CAR-transduced autologous T cells administered intravenously after a conditioning chemotherapy regimen consisting of fludarabine and cyclophosphamide, administered over 3 days.

Individual participants will remain in the active post-treatment period for approximately 2 years. Participants will continue in long-term follow-up for 15 years from treatment.

Eligibility

If you are willing and able to provide written informed consent

If you are at least 18 years old.

You cannot participate in this study if you are female who is pregnant or breastfeeding or planning to become pregnant.

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University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

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