Relapsed/Refractory Non-Hodgkin LymphomasNCT06331832
Expanded Access of Imvotamab (IGM-2323) in Patients With R/R NHL
A study testing IGM2323 in people with Relapsed/Refractory Non-Hodgkin Lymphomas, run by IGM Biosciences, Inc. at 3 sites in 3 countries.
Trial summary
Expanded Access of Imvotamab (IGM-2323) in Patients with Relapsed/Refractory Non-Hodgkin Lymphomas from IGM-2323-001 clinical trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/Refractory Non-Hodgkin Lymphomas
- What is being tested?
- IGM2323
- How many people
- Not given
- Where
- 3 sitesin 3 countries
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Treatment Guidelines for Expanded Access of Imvotamab (IGM-2323) in Patients With Relapsed/Refractory Non-Hodgkin Lymphomas From IGM-2323-001
Expanded Access of Imvotamab (IGM-2323) in Patients with Relapsed/Refractory Non-Hodgkin Lymphomas from IGM-2323-001 clinical trial.
- Being tested
- IGM2323
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IGM2323Biological
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 CD3ε.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Non-Hodgkin LymphomasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- IGM Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06331832
- Sponsor's protocol ID
- 2323-EAP
- Other IDs
- 2021-002339-44
- Status last verified
- Mar 2024
- First submitted
- 19 Mar 2024
- Last updated
- 26 Mar 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Guidelines for Expanded Access of Imvotamab (IGM-2323) in Patients With Relapsed/Refractory Non-Hodgkin Lymphomas From IGM-2323-001
- ClinicalTrials.gov ID
- NCT06331832
- Acronym / sponsor ID
- 2323-EAP
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- IGM Biosciences, Inc.Industry (pharma, biotech, devices)
- First posted
- 26 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Expanded Access of Imvotamab (IGM-2323) in Patients with Relapsed/Refractory Non-Hodgkin Lymphomas from IGM-2323-001 clinical trial.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IGM2323Imvotamab 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 CD3ε. | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IGM2323 in people with Relapsed/Refractory Non-Hodgkin Lymphomas, run by IGM Biosciences, Inc. at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia, South Korea, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.