Evaluating the safety of INT2104 for patients with relapsed B-cell cancer
A Two-Part Open Label Phase 1 Multicentre Study Evaluating the Safety of INT2104 Infusions in Female and Male Participants Aged 18 Years of Age and Older with Refractory/Relapsing B-cell Malignancies
This study is testing a new gene therapy called INT2104 to see if it is safe for adults with relapsed B-cell cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Interius BioTherapeutics Inc. Industry-sponsored |
| Drugs / interventions | CAR-T, CAR T, chimeric antigen receptor |
| Locations | 2 sites (Melbourne and 1 other locations) |
| Trial ID | NCT06539338 on ClinicalTrials.gov |
What this trial studies
This Phase 1 clinical trial aims to assess the safety and tolerability of INT2104, a gene therapy designed to generate CAR T and CAR Natural Killer cells targeting CD20, in adults with relapsed or refractory B-cell malignancies. Participants will receive a one-time intravenous infusion of INT2104, and the study will be conducted in two parts: a dose escalation phase followed by a confirmation phase. The trial will also gather preliminary efficacy data to inform future studies. Participants will be monitored through regular clinic visits after treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with relapsed or refractory B-cell non-Hodgkin lymphoma who have received at least two prior lines of systemic therapy.
Not a fit: Patients who have not had prior CAR-T cell therapy or those with non-CD20 positive tumors may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a new treatment option for patients with difficult-to-treat B-cell cancers.
How similar studies have performed: Other studies using CAR T-cell therapies have shown promising results, indicating potential for success with this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 or older and capable of giving signed informed consent * Diagnosed with relapsed/refractory (R/R) B-cell non-Hodgkin lymphoma (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 methodafter 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-cell acute lymphoblastic leukaemia (B-ALL), and with exceptions as detailed in exclusion criteria. Participants with Philadelphia chromosome (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 of chronic lymphocytic leukaemia (CLL) (including large cell \[Richter\] transformation of CLL) or small lymphocytic lymphoma (SLL) * Diagnosis 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, non-melanoma skin 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
Where this trial is running
Melbourne and 1 other locations
- Peter MacCallum Cancer Centre — Melbourne, Australia (Recruiting)
- Westmead Hospital — Westmead, Australia (Recruiting)
Study contacts
- Principal investigator: Michael Dickinson, MBBS FRACP — Peter MacCallum Cancer Centre, Australia
- Study coordinator: VP Portfolio & Program Development
- Email: INT2104-101@interiusbio.com
- Phone: +1 215-608-9333
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.