Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06331832




Registration number
NCT06331832
Ethics application status
Date submitted
19/03/2024
Date registered
26/03/2024
Date last updated
26/03/2024

Titles & IDs
Public title
Expanded Access of Imvotamab (IGM-2323) in Patients With R/R NHL
Scientific title
Treatment Guidelines for Expanded Access of Imvotamab (IGM-2323) in Patients With Relapsed/Refractory Non-Hodgkin Lymphomas From IGM-2323-001
Secondary ID [1] 0 0
2021-002339-44
Secondary ID [2] 0 0
2323-EAP
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsed/Refractory Non-Hodgkin Lymphomas 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

Intervention/exposure
Study type
Expanded Access
Description of intervention(s) / exposure
Other interventions - IGM2323

Other interventions: IGM2323
Imvotamab is a recombinant monoclonal antibody of the IgM kappa isotype that targets the human CD20 antigen. Its component J-chain is fused to a single chain Fv antibody fragment which targets human CD3e.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
- Demonstrated clinical benefit (SD, PR, or CR) on clinical trial protocol IGM-2323-001

- There is no adequate alternative treatment available for the patient.

- Provided consent to continue treatment on expanded access program.

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

- Women of childbearing potential must have a negative serum pregnancy test result
within 14 days prior to the first dose.

- For women of childbearing potential: agreement to remain abstinent (refrain from
heterosexual intercourse) or use highly effective contraceptive measures.

- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use
highly effective contraceptive.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- History of severe allergic or anaphylactic reactions to mAb (or recombinant antibody
related fusion proteins).

- Any medical condition or clinical laboratory abnormality likely to interfere with
assessment of safety or efficacy of investigational product, or indicating patient
would unlikely have potential benefit.

- Pregnant, breastfeeding, or intending to become pregnant during the program or within
2 months after the final dose of imvotamab.

- In the treating physician's judgement, the patient is unlikely to complete all
procedures, including follow-up visits, or comply with the requirements for
participation.

- Vaccination with live virus vaccines during treatment and for 3 months following the
last cycle of Imvotamab.

Study design
Purpose of the study
Allocation to intervention
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
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
No longer available
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
- Nedlands
Recruitment outside Australia
Country [1] 0 0
Korea, Republic of
State/province [1] 0 0
Gangnam-gu
Country [2] 0 0
Spain
State/province [2] 0 0
Madrid

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
IGM Biosciences, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Expanded Access of Imvotamab (IGM-2323) in Patients with Relapsed/Refractory Non-Hodgkin
Lymphomas from IGM-2323-001 clinical trial.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06331832
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06331832