Long-Term Follow-Up Study of Gamgertamig
ConditionAutoimmune Cytopenias
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorLakefront Biotherapeutics West LLC
About this trial
This study will follow adults who previously received gamgertamig in another clinical study to evaluate long-term safety and clinical outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Not applicable.
Trial population
Adults who completed treatment and continue to demonstrate a clinical response in an eligible parent gamgertamig study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Observational
Other interventionPrior treatment with gamgertamig in an eligible parent study. No gamgertamig is administered in this follow-up study.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Participants Previously Treated With Gamgertami1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants With Adverse Events
Incidence, severity, seriousness, and frequency of adverse events.
Time frame
From study entry through Week 52Secondary outcomes
1
Anti-Drug Antibodies to Gamgertamig
Incidence, prevalence, and titers of anti-drug antibodies.
Time frame
From study entry through Week 52Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: