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Safety of INT2104 in Participants Aged 18 Years and Older Who Have B-cell Cancer That Came Back After Prior Treatment

PHASE1RECRUITING

The purpose of this first-in-human study is to evaluate the safety 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.

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Study details:

This is a non-randomized, open label, multi-site, Phase 1 First in Human (FIH) study 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. 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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

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

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 criteria

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

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2024-10-01

Primary completion: 2028-03-01

Study completion finish: 2031-03-01

Study type

TREATMENT

Phase

PHASE1

Trial ID

NCT06539338

Intervention or treatment

GENETIC: INT2104

Conditions

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

Image related to Lymphomas Non-Hodgkin's B-Cell

Condition: Lymphomas Non-Hodgkin's B-Cell, Precursor Cell Lymphoblastic Leukemia-Lymphoma
GENETIC: INT2104
Melbourne, Not Specified, Australia and more
Sponsor: Interius BioTherapeutics Inc.

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Peter MacCallum Cancer Centre

Research sites nearby

Select from list below to view details:

Peter MacCallum Cancer Centre
Melbourne, Not Specified, Australia
Westmead Hospital
Westmead, Not Specified, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: INT2104 Dose Level 1 Single IV administration of INT2104	GENETIC: INT2104 INT2104 is a lentiviral vector delivering a transgene for a chimeric antigen receptor specific for CD20 (CAR20)
EXPERIMENTAL: INT2104 Dose Level 2 Single IV administration of INT2104	GENETIC: INT2104 INT2104 is a lentiviral vector delivering a transgene for a chimeric antigen receptor specific for CD20 (CAR20)
EXPERIMENTAL: INT2104 Dose Level 3 Single IV administration of INT2104	GENETIC: INT2104 INT2104 is a lentiviral vector delivering a transgene for a chimeric antigen receptor specific for CD20 (CAR20)
EXPERIMENTAL: INT2104 Recommended Dose Single IV administration of INT2104	GENETIC: INT2104 INT2104 is a lentiviral vector delivering a transgene for a chimeric antigen receptor specific for CD20 (CAR20)

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Number of Participants With Adverse Events as Assessed by CTCAE v5.0	Number of Participants With Adverse Events as Assessed by CTCAE v5.0	28 days
Number of Participants With Adverse Events as Assessed by CTCAE v5.0	Number of Participants With Adverse Events as Assessed by CTCAE v5.0	90 days
Number of Participants With Adverse Events as Assessed by CTCAE v5.0	Number of Participants With Adverse Events as Assessed by CTCAE v5.0	2 years
Number of participants experiencing Cytokine Release Syndrome (CRS)	Number of participants experiencing Cytokine Release Syndrome (CRS)	28 Days
Number of participants experiencing Immune Effector Cell Neurotoxicity (ICANS)	Number of participants experiencing Immune Effector Cell Neurotoxicity (ICANS)	28 Days
Number of participants experiencing dose-limiting toxicities (DLTs)	Number of participants experiencing dose-limiting toxicities (DLTs)	28 Days

Secondary outcome

Frequently Asked Questions

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References

Clinical Trials Gov: Safety of INT2104 in Participants Aged 18 Years and Older Who Have B-cell Cancer That Came Back After Prior Treatment