NCT04684563

huCART19-IL18 in CD19+ Cancers

Phase I Trial of huCART19-IL18 Cells in Patients With Relapsed or Refractory CD19+ Cancers

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and feasibility of huCART19-IL18 cells in patients with relapsed or refractory CD19+ cancers.

Detailed description

This is a Phase I study to assess the safety, tolerability, manufacturing feasibility, pharmacokinetics, and preliminary efficacy of huCART19-IL18 cells in patients with CD19+ cancers. The study will take place in two parts: an initial Dose-Finding Phase and an Expansion Phase. In the dose-finding phase, the maximum tolerated dose will be determined using a Bayesian Optimal Interval (BOIN) design within each of the following disease-specific cohorts: * Cohort A: Non-Hodgkin Lymphoma (Active, Not Recruiting) * Cohort B: Chronic Lymphocytic Leukemia (Active, Not Recruiting) * Cohort C: Acute Lymphoblastic Leukemia (Active, Not Recruiting) * Cohort D (Expansion Phase): Non Hodgkin Lymphoma and Acute Lymphoblastic Leukemia (Active, Not Recruiting) will evaluate changes to cell activation method in the huCART19-IL18 manufacturing process using the recommended dose for expansion (RDE) arising out of the dose-finding phase.

Conditions

• Chronic Lymphocytic Leukemia
• Non-hodgkin Lymphoma
• Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	huCART19-IL18	autologous Chimeric Antigen Receptor (CAR) T cells directed against the human CD19 antigen that also express human Interleukin 18 (IL-18)

Timeline

• Start date: 2021-05-06
• Primary completion: 2036-05-01
• Completion: 2036-05-01
• First posted: 2020-12-24
• Last updated: 2025-11-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study