Safety of INT2104 in Participants Aged 18 Years and Older Who Have B-cell Cancer That Came Back After Prior Treatment

Launched by INTERIUS BIOTHERAPEUTICS INC. · Aug 1, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called INT2104 for adults aged 18 and older who have certain types of B-cell cancers, such as non-Hodgkin lymphoma or acute lymphoblastic leukemia, that have not responded to previous treatments. INT2104 is a type of gene therapy that aims to help the body produce special immune cells designed to target and attack cancer cells. The trial will last for five years, and participants will receive a single intravenous (IV) infusion of the treatment.

To be eligible for this trial, participants must be adults who have been diagnosed with specific types of B-cell cancer and have shown progression after at least two different treatment regimens. They should have measurable disease and specific blood counts that meet the trial's criteria. Participants can expect to receive the treatment and will be closely monitored for any side effects or responses to the therapy. It's important to note that there are certain conditions that would exclude someone from participating, such as having other active cancers or specific heart or immune system issues.

Gender

ALL

Eligibility 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