- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07340814
A Long-term Follow-up Study of Patients Who Received MB-105
January 6, 2026 updated by: March Biosciences Inc
This study is to fulfil the regulatory requirement for 15-year follow-up for patients treated with MB-105 in any study
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
This study is for long term follow up of efficacy and safety for any patient treated with MB-105 who has consented to joining the LTFU study.
There are no exclusion criteria.
Study Type
Observational
Enrollment (Estimated)
40
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Patients who previously received MB-105 and consent to participate
Description
Inclusion Criteria:
Received MB-105 Signed informed consent Agree to transfer of samples from previous study Able to comply with study requirements
Exclusion Criteria:
N/A
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Open Observation
All patients who previously received MB-105 on another study
|
This is an observational study with no study product administered because it is the LTFU study for patients who received the product in another study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assess long term safety of MB-105 in patients who received MB-105
Time Frame: 15 Years
|
SAEs
|
15 Years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assess long term efficacy of MB-105 in patients who received MB-105
Time Frame: 15 Years
|
Time to progression/relapse in those who have not yet relapsed and overall survival
|
15 Years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
February 27, 2026
Primary Completion (Estimated)
October 15, 2040
Study Completion (Estimated)
October 15, 2040
Study Registration Dates
First Submitted
January 6, 2026
First Submitted That Met QC Criteria
January 6, 2026
First Posted (Actual)
January 14, 2026
Study Record Updates
Last Update Posted (Actual)
January 14, 2026
Last Update Submitted That Met QC Criteria
January 6, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- MB-105-202
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.