Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18+
Clinical summary
Summary
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.
The aim of the study is to collect data to assess whether INT2104 is safe and tolerabe, and understand how well INT2104 works in the human body, and to select the dose to take into a Phase 2 study.
The study is split into two parts: the first Part (Part A) is a dose escalation and the second part (Part B) will be to confirm the dose. All participants will receive on 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 follwoed regularly with clinic visits after they receive INT2104.
Conditions
This trial is treating people with relapsed or refractory B-cell non-Hodgkin lymphoma that is CD20 positive (Burkitt's lymphoma patients are eligible for Part B only).
Eligibility
Inclusion
- Age 18 or older and capable of giving signed informed consent
- Diagnosed with relapsed/refractory (R/R) B-cell non-Hodgkin lymphoma (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 methodafter 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-cell acute lymphoblastic leukaemia (B-ALL), and with exceptions as detailed in exclusion criteria. Participants with Philadelphia chromosome (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
Exclusion
- Central Nervous System (CNS)-only B-cell malignancy, or B-cell malignancy with R/R secondary CNS involvement.
- Diagnosis of chronic lymphocytic leukaemia (CLL) (including large cell [Richter] transformation of CLL) or small lymphocytic lymphoma (SLL)
- Diagnosis 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, non-melanoma skin 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
Inclusion
- You have had treatment, but your cancer has come back (relapsed or recurrent).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- You have had a certain type of treatment or surgical procedure.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
- NCT06539338 *
- INT2104-101; 2023-509132-26-00; U1111-1303-9462
Trial sponsor
Interius BioTherapeutics Inc.
Scientific Title
A Two-Part Open Label Phase 1 Multicentre Study Evaluating the Safety of INT2104 Infusions in Female and Male Participants Aged 18 Years of Age and Older with Refractory/Relapsing B-cell Malignancies
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