Brief Summary
The purpose of this first-in-human study is to evaluate the safety 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) cellsthe basic structural and functional unit of all living things inside the body following intravenousinto or within a vein (IV) administration.
Study details include the following:
- The study duration will be 5 years
- The treatment duration will be a one-time intravenous (IV) infusionto slowly introduce/give fluid into a vein of INT2104
Intervention / Treatment
- Genetic: INT2104
Inclusion Criteria:
- Age 18 or older and capable of giving signed informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment.
- Diagnosed with relapsed/refractory (R/R) B-cell non-Hodgkin lymphomacancers of the lymphatic system (B-NHL) (Burkitt’s lymphoma are eligible for Part B only) confirmed by histology or flow cytometry Note: Bone Marrowsoft, spongy tissue found in bones that makes blood cells involvement is allowed
- B-NHL must have CD20 antigen positive tumoura tissue mass that forms from groups of unhealthy cells confirmed from a tumour biopsyremoval of a section of tissue to analyse for cancer cells taken at screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer 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 trialsresearch studies performed to test new treatments, tests or procedures and evaluate their effectiveness on various diseases 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 Oncologythe study, diagnosis and treatment of cancer 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 acutenew, recent, comes with an urgent or significant sense, is sudden, sharp lymphoblastic leukaemiacancer of blood and/or blood forming tissues (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