Autoimmune CytopeniasNCT07847892
Long-Term Follow-Up Study of Gamgertamig
An observational study of Autoimmune Cytopenias, run by Lakefront Biotherapeutics West LLC.
Trial summary
This study will follow adults who previously received gamgertamig in another clinical study to evaluate long-term safety and clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Autoimmune Cytopenias
- What is being tested?
- Observational
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults who completed treatment and continue to demonstrate a clinical response in an eligible parent gamgertamig study.
Who may be able to join
- Completed the protocol-defined treatment regimen in an eligible parent gamgertamig study.
- Achieved and continues to demonstrate a clinical response.
- Able and willing to provide informed consent.
Who cannot join
- Not applicable.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Long-Term Follow-Up Study in Participants Who Previously Participated in a Gamgertamig (OM336) Parent Clinical Study
This study will follow adults who previously received gamgertamig in another clinical study to evaluate long-term safety and clinical outcomes.
- Conditions
- Autoimmune Cytopenias
- Being tested
- Observational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Prior treatment with gamgertamig in an eligible parent study. No gamgertamig is administered in this follow-up study.
| Study group | Role | What they receive |
|---|---|---|
| Participants Previously Treated With Gamgertami | Participants who completed an eligible parent gamgertamig study Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
Incidence, severity, seriousness, and frequency of adverse events.
Measured: From study entry through Week 52
Secondary outcomes (1)
Anti-Drug Antibodies to Gamgertamig
Incidence, prevalence, and titers of anti-drug antibodies.
Measured: From study entry through Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune CytopeniasStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lakefront Biotherapeutics West LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07847892
- Sponsor's protocol ID
- OM336-LTF-1004
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Long-Term Follow-Up Study in Participants Who Previously Participated in a Gamgertamig (OM336) Parent Clinical Study
- ClinicalTrials.gov ID
- NCT07847892
- Acronym / sponsor ID
- OM336-LTF-1004
- Conditions
- Autoimmune Cytopenias
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Lakefront Biotherapeutics West LLCIndustry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 29 Sep 2026 (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.
This study will follow adults who previously received gamgertamig in another clinical study to evaluate long-term safety and clinical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants Previously Treated With Gamgertami | – | Other: ObservationalParticipants who completed an eligible parent gamgertamig study |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults who completed treatment and continue to demonstrate a clinical response in an eligible parent gamgertamig study.
Key inclusion criteria (3 listed)
- Completed the protocol-defined treatment regimen in an eligible parent gamgertamig study.
- Achieved and continues to demonstrate a clinical response.
- Able and willing to provide informed consent.
Key exclusion criteria (1 listed)
- Not applicable.
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 |
|---|---|---|
| ObservationalPrior treatment with gamgertamig in an eligible parent study. No gamgertamig is administered in this follow-up study. | Other | Participants Previously Treated With Gamgertami |
Primary outcome
Number of Participants With Adverse Events
Time frame: From study entry through Week 52
Incidence, severity, seriousness, and frequency of adverse events.
1 secondary outcome
Anti-Drug Antibodies to Gamgertamig
Time frame: From study entry through Week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune Cytopenias, run by Lakefront Biotherapeutics West LLC.
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 3 inclusion and 1 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: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Sponsor (415-429-4887, clinicaltrials@lakefrontbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (time frame: From study entry through Week 52). It is what the study was designed to measure, not a finding.
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 29 Sep 2026.