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

Last updated: April 23, 2026
Sponsor: Kite, A Gilead Company
Overall Status: Active - Not Recruiting

Phase

1

Condition

Lymphoma

Lymphoma, B-cell

Treatment

INT2104

Clinical Study ID

NCT06539338
INT2104-101
U1111-1303-9462
2023-509132-26-00
  • Ages > 18
  • All Genders

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosed with relapsed/refractory (R/R) B-NHL (Burkitt's lymphoma are eligible forPart B only) confirmed by histology or flow cytometry Note: Bone Marrow involvementis allowed

  • B-NHL must have CD20 antigen positive tumour confirmed from a tumour biopsy taken atscreening

  • Measurable disease at the time of enrolment

  • Progression after at least 2 lines of systemic therapy

  • Has not received more than one prior marketed CAR-T cell therapy (including tandemor bispecific CAR-T) or other genetically modified T-cell therapy.

  • Sex and Contraceptive/Barrier Requirements consistent with local regulations forclinical trials Females: must have negative serum pregnancy test at screening and onDay -1 prior to INT2104 infusion Both sexes: must agree to use highly effectivemethods, including a barrier method after INT2104 infusion

  • Haematological criteria:

  • Absolute lymphocyte count (ALC) ≥300/µL

  • Platelet count ≥50,000/mL

  • Absolute neutrophil count (ANC) ≥500/µL

  • Eastern Cooperative Oncology Group (ECOG) score of 0 or 1

  • Adequate renal, cardiac, hepatic, and lung function

Key Inclusion Part B only

  • Diagnosed with relapsed/refractory B-ALL, and with exceptions as detailed inexclusion criteria. Participants with Philadelphia chromosome positive (Ph+) B-ALLdisease are eligible.

  • B-ALL participants must have CD20 antigen positive leukaemia

  • Measurable disease at the time of enrolment

  • Participants with Burkitt's lymphoma are eligible for Part B only

Exclusion

Exclusion Criteria:

  • Central Nervous System (CNS)-only B-cell malignancy, or B-cell malignancy with R/Rsecondary CNS involvement.

  • Diagnosis or history of chronic lymphocytic leukaemia (CLL) (including large cell [Richter] transformation of CLL) or small lymphocytic lymphoma (SLL)

  • Diagnosis or history of cutaneous lymphoma

  • History of another primary malignancy that has not been in remission for at least 3years before signing informed consent (except for: non-melanoma skin cancer, lowgrade prostate cancer or carcinoma in situ (e.g., cervix, bladder, breast))

  • Acute or chronic graft-versus-host disease

  • Participant has received donor lymphocyte infusion within 6 weeks prior to INT2104infusion

  • History of autoimmune disease requiring systemic immunosuppression/ systemic diseasemodifying agents within 2 years before enrolment

  • History or presence of CNS disorder

  • History of myocardial infarction, cardiac angioplasty or stenting, unstable angina,or other clinically significant cardiac disease within 12 months before signinginformed consent

  • Participants has active syphilis, cytomegalovirus (CMV), acute or chronic activehepatitis B, or untreated hepatitis C.

  • Participant is Human immunodeficiency virus (HIV) positive.

  • Any medical condition likely to interfere with assessment of safety or efficacy ofthe study treatment

  • A vaccine within 4 weeks prior to INT2104 infusion

  • Intolerance or severe hypersensitivity reaction to any excipients of the INT2104product.

  • An active fungal, bacterial, viral, or other infection that is uncontrolled orrequires antimicrobials at the time of INT2104 infusion.

  • Participant is pregnant or nursing.

  • In the investigator's judgment, the participant is unlikely to complete allprotocol-required study visits or procedures, including follow-up visits, or complywith the study requirements for participation

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: INT2104
Phase: 1
Study Start date:
September 20, 2024
Estimated Completion Date:
July 31, 2026

Study 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

Connect with a study center

  • Westmead Hospital

    Westmead, New South Wales 2145
    Australia

    Site Not Available

  • Westmead Hospital

    Westmead 2143973, New South Wales 2155400 2145
    Australia

    Site Not Available

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria 3000
    Australia

    Site Not Available

  • Peter MacCallum Cancer Centre

    Melbourne 2158177, Victoria 2145234 3000
    Australia

    Site Not Available

  • Hospital MD Anderson

    Madrid, 28033
    Spain

    Site Not Available

  • Hospital MD Anderson

    Madrid 3117735, 28033
    Spain

    Site Not Available

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