One-Time infusion aims to build cancer killers inside the body
NCT ID NCT06539338
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Burkitt lymphoma are added.
Genom att skicka in godkänner du våra Användarvillkor
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Engineered immune cells aim to wipe out stubborn leukemia
- Tweaking donor cells may shield older transplant patients from a dangerous complication
- Engineered immune cells take aim at Hard-to-Treat lymphomas
- Can a cheaper copy of a leukemia drug work just as well?
- Double-Pronged immune cells take aim at stubborn blood cancers
- New transplant recipe aims to tame Graft-Versus-Host disease