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
NCT ID: NCT06539338
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
34 participants
INTERVENTIONAL
2024-10-07
2031-03-31
Brief Summary
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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
Detailed Description
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The aim of the study is to collect data to assess whether the study product, INT2104, is safe and tolerable, to understand how well INT2104 works in the human body and to select the dose to take into a Phase 2 study.
All participants will receive one intravenous (IV) infusion of INT2104.
Each participant in the study will follow the same study treatment schedule and will proceed through the following study periods:
* Screening Period: participant will be assessed for eligibility
* Study Day 1: participants who meet all eligibility criteria will receive INT2104 by a one-time infusion
* Post-treatment Assessment Period: participants will be followed regularly with clinic visits after they receive INT2104
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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INT2104 Dose Level 1
Single IV administration of INT2104
INT2104
INT2104 is a lentiviral vector delivering a transgene for a chimeric antigen receptor specific for CD20 (CAR20)
INT2104 Dose Level 2
Single IV administration of INT2104
INT2104
INT2104 is a lentiviral vector delivering a transgene for a chimeric antigen receptor specific for CD20 (CAR20)
INT2104 Dose Level 3
Single IV administration of INT2104
INT2104
INT2104 is a lentiviral vector delivering a transgene for a chimeric antigen receptor specific for CD20 (CAR20)
INT2104 Dose Level 4
Single IV administration of INT2104
INT2104
INT2104 is a lentiviral vector delivering a transgene for a chimeric antigen receptor specific for CD20 (CAR20)
INT2104 Recommended Dose
Single IV administration of INT2104
INT2104
INT2104 is a lentiviral vector delivering a transgene for a chimeric antigen receptor specific for CD20 (CAR20)
Interventions
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INT2104
INT2104 is a lentiviral vector delivering a transgene for a chimeric antigen receptor specific for CD20 (CAR20)
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Measurable disease at the time of enrolment
* Participants with Burkitt's lymphoma are eligible for Part B only
* 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
* 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
18 Years
ALL
No
Sponsors
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Kite, A Gilead Company
INDUSTRY
Responsible Party
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Principal Investigators
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Kite Study Director
Role: STUDY_DIRECTOR
Kite, A Gilead Company
Locations
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Westmead Hospital
Westmead, New South Wales, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Hospital MD Anderson
Madrid, , Spain
Countries
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Central Contacts
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Other Identifiers
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2023-509132-26-00
Identifier Type: CTIS
Identifier Source: secondary_id
U1111-1303-9462
Identifier Type: OTHER
Identifier Source: secondary_id
INT2104-101
Identifier Type: -
Identifier Source: org_study_id