A Two-Part Open Label Phase 1 Multicentre Study Evaluating the Safety of INT2104 Infusion in Female and Male Participants Aged 18 Years of Age and Older With Refractory/Relapsing B-Cell Malignancies
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
• 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