huCART19-IL18 in NHL/CLL Patients

  • STATUS
    Recruiting
  • End date
    May 3, 2036
  • participants needed
    30
  • sponsor
    University of Pennsylvania
Updated on 3 November 2021
chronic lymphocytic leukemia
lymphoma
leukemia

Summary

The purpose of this study is to find the maximum dose of huCART19-IL18 cells that is safe for use in humans with Non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL).

Description

This is a Phase I dose finding study to determine the maximum tolerated dose (MTD) and assess the safety, tolerability, manufacturing feasibility, pharmacokinetics, and preliminary efficacy of huCART19-IL18 cells in patients with Non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL). This trial will evaluate up to 7 dose levels using the Bayesian Optimal Interval (BOIN) design with accelerated titration to determine the maximum tolerated dose (MTD) of huCART19-IL18 cells. Subjects will be assigned to a dose level prior to study treatment based on available safety experience at the current and prior dose levels. huCART19-IL18 cells will be administered to all subjects as a single intravenous (IV) infusion or slow IV push, depending on the assigned dose level. For consistency, the huCART19-IL18 infusions will be identified as IV infusions throughout the protocol.

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Details
Condition non-hodgkin's lymphoma (nhl), small lymphocytic lymphoma, chronic lymphocytic leukemia (cll), Lymphoma, leukemia chronic lymphocytic, Lymphocytic Leukemia, Chronic, Chronic Lymphocytic Leukemia, Non-Hodgkin's Lymphoma
Treatment huCART19-IL18
Clinical Study IdentifierNCT04684563
SponsorUniversity of Pennsylvania
Last Modified on3 November 2021

Eligibility

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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