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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06539338




Registration number
NCT06539338
Ethics application status
Date submitted
19/06/2024
Date registered
6/08/2024
Date last updated
26/10/2024

Titles & IDs
Public title
Safety of INT2104 in Participants Aged 18 Years and Older Who Have B-cell Cancer That Came Back After Prior Treatment
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
Secondary ID [1] 0 0
2023-509132-26-00
Secondary ID [2] 0 0
INT2104-101
Universal Trial Number (UTN)
Trial acronym
INVISE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphomas Non-Hodgkin's B-Cell 0 0
Precursor Cell Lymphoblastic Leukemia-Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Leukaemia - Acute leukaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - INT2104

Experimental: INT2104 Dose Level 1 - Single IV administration of INT2104

Experimental: INT2104 Dose Level 2 - Single IV administration of INT2104

Experimental: INT2104 Dose Level 3 - Single IV administration of INT2104

Experimental: INT2104 Recommended Dose - Single IV administration of INT2104


Treatment: Other: INT2104
INT2104 is a lentiviral vector delivering a transgene for a chimeric antigen receptor specific for CD20 (CAR20)
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Adverse Events as Assessed by CTCAE v5.0
Timepoint [1] 0 0
28 days
Primary outcome [2] 0 0
Number of Participants With Adverse Events as Assessed by CTCAE v5.0
Timepoint [2] 0 0
90 days
Primary outcome [3] 0 0
Number of Participants With Adverse Events as Assessed by CTCAE v5.0
Timepoint [3] 0 0
2 years
Primary outcome [4] 0 0
Number of participants experiencing Cytokine Release Syndrome (CRS)
Timepoint [4] 0 0
28 Days
Primary outcome [5] 0 0
Number of participants experiencing Immune Effector Cell Neurotoxicity (ICANS)
Timepoint [5] 0 0
28 Days
Primary outcome [6] 0 0
Number of participants experiencing dose-limiting toxicities (DLTs)
Timepoint [6] 0 0
28 Days

Eligibility
Key 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

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/10/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2031
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [2] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment postcode(s) [2] 0 0
- Westmead

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Interius BioTherapeutics Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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
Trial website
https://clinicaltrials.gov/study/NCT06539338
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Elizabeth Tarka, MD, FACC
Address 0 0
[email protected]
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
VP Portfolio & Program Development
Address 0 0
Country 0 0
Phone 0 0
+1 215-608-9333
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06539338