NCT06539338

A Study to Investigate Safety of INT2104 Infusions in Participants Aged 18 Years of Age and Older Who Have B-cell Cancers That Came Back After Previous Treatment

A Two-Part Open Label Phase 1 Multicentre Study Evaluating the Safety of INT2104 Infusion in Female and Male Participants Aged 18 Years of Age and Older With Refractory/Relapsing B-Cell Malignancies

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Kite, A Gilead Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this first-in-human study is to evaluate the safety and tolerability of INT2104 when administered to humans in a broad population of participants with refractory/relapsing B-cell malignancies. Preliminary efficacy information may also be obtained. INT2104 is a gene therapy delivering a transgene for a chimeric antigen receptor (CAR) specific for CD20 (CAR20). The lentiviral vector is designed to generate CAR T and CAR Natural Killer (NK) cells inside the body following intravenous (IV) administration. Study details include the following: * The study duration will be 5 years * The treatment duration will be a one-time intravenous (IV) infusion of INT2104

Detailed description

This is a non-randomized, open label, multi-site, Phase 1 First in Human (FIH) study split into two parts. The first part (Part A) is a dose escalation and the second part (Part B) will be to confirm the dose. The aim of the study is to collect data to assess whether the study product, INT2104, is safe and tolerable, to understand how well INT2104 works in the human body and to select the dose to take into a Phase 2 study. All participants will receive one intravenous (IV) infusion of INT2104. Each participant in the study will follow the same study treatment schedule and will proceed through the following study periods: * Screening Period: participant will be assessed for eligibility * Study Day 1: participants who meet all eligibility criteria will receive INT2104 by a one-time infusion * Post-treatment Assessment Period: participants will be followed regularly with clinic visits after they receive INT2104

Conditions

• Lymphomas Non-Hodgkin's B-Cell
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Type	Name	Description
GENETIC	INT2104	INT2104 is a lentiviral vector delivering a transgene for a chimeric antigen receptor specific for CD20 (CAR20)

Timeline

• Start date: 2024-09-20
• Primary completion: 2028-03-01
• Completion: 2031-03-01
• First posted: 2024-08-06
• Last updated: 2026-02-04

Locations

3 sites across 2 countries: Australia, Spain

Regulatory

• FDA-regulated drug study