huCART19-IL18 in NHL/CLL Patients
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Chronic Lymphocytic Leukemia
- Non Hodgkin Lymphoma
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: 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.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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). Thi...
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. .
Tracking Information
- NCT #
- NCT04684563
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Jakub Svoboda, MD University of Pennsylvania
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