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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

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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Elizabeth Tarka, MD, FACC
Address 0 0
INT2104-101@interiusbio.com
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
INT2104-101@interiusbio.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
At this time it is undecided if individual participant data will be made available to other researchers due to the first in human, first in class nature of the study.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
Access will begin 9 months and end 24 months following the closure of the clinical trial and following article publication.
Available to whom?
Redacted study protocol and statistical analysis plan and data may be made available upon request to researchers who provide a methodologically sound proposal. Proposals should be directed to INT2104-101@interiusbio.com. To gain access, data requestors will need to sign a data access agreement.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06539338