A Study to Investigate Safety of INT2104 Infusions in Participants Aged 18 Years of Age and Older Who Have B-cell Cancers That Came Back After Previous Treatment

Korábbi kezelés

• History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months before signing informed consent
• A vaccine within 4 weeks prior to INT2104 infusion

Más betegség

• 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
• History of autoimmune disease requiring systemic immunosuppression/ systemic disease modifying agents within 2 years before enrolment
• History or presence of CNS disorder
• 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
• 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.

Laborértékek

• Participant has received donor lymphocyte infusion within 6 weeks prior to INT2104 infusion

Egyéb

• 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.

• 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