huCART19-IL18 in NHL/CLL Patients

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


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).


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.


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


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