OVERVIEW
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 (INVISE)
PROTOCOL SUMMARY
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
View moreParticipation requirements
Age
18 years +
Sex
All
Healthy Volunteers
No
Age
18 years +
Sex
All
Healthy Volunteers
No
Study details
Medical Condition
Lymphomas Non-Hodgkin's B-Cell, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Gender
N/A
Date
September 2024 - July 2026
Study Type
Interventional
Study Phase
Phase 1
Product
INT2104
Eligibility information
Inclusion criteria
- 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
- 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 Criteria:
- 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
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Locations
Locations (3)
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