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One-Time infusion aims to build cancer killers inside the body

NCT ID NCT06539338

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 09, 2026 · Updated 2 times

Summary

This early study tests a new gene therapy called INT2104 in 10 adults with B-cell cancers that have come back or not responded to treatment. The therapy is given as a single IV infusion and works by instructing the body to create its own cancer-fighting T cells and natural killer cells. The main goal is to check safety, but researchers will also look for signs that the treatment is working.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

10 people

The number who actually took part.

Started

Sep 2024

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Diagnosed with relapsed/refractory (R/R) B-NHL (Burkitt's lymphoma are eligible for Part B only) confirmed by histology or flow cytometry Note: Bone Marrow involvement is allowed * B-NHL must have CD20 antigen positive tumour confirmed from a tumour biopsy taken at screening * 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 tandem or bispecific CAR-T) or other genetically modified T-cell therapy. * Sex and Contraceptive/Barrier Requirements consistent with local regulations for clinical trials Females: must have negative serum pregnancy test at screening and on Day -1 prior to INT2104 infusion Both sexes: must agree to use highly effective methods, 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 in exclusion criteria. Participants with Philadelphia chromosome positive (Ph+) B-ALL disease 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 Criteria: * Central Nervous System (CNS)-only B-cell malignancy, or B-cell malignancy with R/R secondary 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 3 years before signing informed consent (except for: non-melanoma skin cancer, low grade 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 INT2104 infusion * History of autoimmune disease requiring systemic immunosuppression/ systemic disease modifying 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 signing informed consent * Participants has active syphilis, cytomegalovirus (CMV), acute or chronic active hepatitis B, or untreated hepatitis C. * Participant is Human immunodeficiency virus (HIV) positive. * Any medical condition likely to interfere with assessment of safety or efficacy of the study treatment * A vaccine within 4 weeks prior to INT2104 infusion * Intolerance or severe hypersensitivity reaction to any excipients of the INT2104 product. * An active fungal, bacterial, viral, or other infection that is uncontrolled or requires antimicrobials at the time of INT2104 infusion. * Participant is pregnant or nursing. * In the investigator's judgment, the participant is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Hospital MD Anderson

    Madrid, 28033, Spain

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000, Australia

  • Westmead Hospital

    Westmead, New South Wales, 2145, Australia

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