Study Details

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

Participation Requirements

Age

18 Years +

Sex

ALL

Healthy Volunteers

Medical Condition

Lymphomas Non-Hodgkin's B-Cell, Precursor Cell Lymphoblastic Leukemia-Lymphoma

Gender

N/A

Date

September 2024 - March 2028

Study Type

INTERVENTIONAL

Study Phase

PHASE1

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)

Westmead Hospital

Westmead, New South Wales, Australia, 2145

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia, 3000

Hospital MD Anderson

Madrid, Spain, 28033

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 (INVISE)

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