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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

NCT06539338 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-04-24

No results posted yet for this study

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

Conditions

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

Interventions

GENETIC

INT2104

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

Sponsors & Collaborators

  • Kite, A Gilead Company

    lead INDUSTRY

Principal Investigators

  • Kite Study Director · Kite, A Gilead Company

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-20
Primary Completion
2026-07-31
Completion
2026-07-31
FDA Drug
Yes

Countries

  • Australia
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06539338 on ClinicalTrials.gov