Phase
Condition
Lymphoma
Lymphoma, B-cell
Treatment
INT2104
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Diagnosed with relapsed/refractory (R/R) B-NHL (Burkitt's lymphoma are eligible forPart B only) confirmed by histology or flow cytometry Note: Bone Marrow involvementis allowed
B-NHL must have CD20 antigen positive tumour confirmed from a tumour biopsy taken atscreening
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 tandemor bispecific CAR-T) or other genetically modified T-cell therapy.
Sex and Contraceptive/Barrier Requirements consistent with local regulations forclinical trials Females: must have negative serum pregnancy test at screening and onDay -1 prior to INT2104 infusion Both sexes: must agree to use highly effectivemethods, 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 inexclusion criteria. Participants with Philadelphia chromosome positive (Ph+) B-ALLdisease 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
Exclusion Criteria:
Central Nervous System (CNS)-only B-cell malignancy, or B-cell malignancy with R/Rsecondary 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 3years before signing informed consent (except for: non-melanoma skin cancer, lowgrade prostate 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 INT2104infusion
History of autoimmune disease requiring systemic immunosuppression/ systemic diseasemodifying 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 signinginformed consent
Participants has active syphilis, cytomegalovirus (CMV), acute or chronic activehepatitis B, or untreated hepatitis C.
Participant is Human immunodeficiency virus (HIV) positive.
Any medical condition likely to interfere with assessment of safety or efficacy ofthe study treatment
A vaccine within 4 weeks prior to INT2104 infusion
Intolerance or severe hypersensitivity reaction to any excipients of the INT2104product.
An active fungal, bacterial, viral, or other infection that is uncontrolled orrequires antimicrobials at the time of INT2104 infusion.
Participant is pregnant or nursing.
In the investigator's judgment, the participant is unlikely to complete allprotocol-required study visits or procedures, including follow-up visits, or complywith the study requirements for participation
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Design
Study Description
Connect with a study center
Westmead Hospital
Westmead, New South Wales 2145
AustraliaSite Not Available
Westmead Hospital
Westmead 2143973, New South Wales 2155400 2145
AustraliaSite Not Available
Peter MacCallum Cancer Centre
Melbourne, Victoria 3000
AustraliaSite Not Available
Peter MacCallum Cancer Centre
Melbourne 2158177, Victoria 2145234 3000
AustraliaSite Not Available
Hospital MD Anderson
Madrid, 28033
SpainSite Not Available
Hospital MD Anderson
Madrid 3117735, 28033
SpainSite Not Available

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