Long-term Safety Follow-up in Recipients Who Previously Received Medeor's Cellular Immunotherapy Products

Immune Tolerance Clinical Trial

Official title:

Extension Study to Assess the Long-Term Safety in Recipients Who Previously Received Medeor's Cellular Immunotherapy Products

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05010174
• Other study ID #: MDR-105-SAE
• Status: Recruiting
• Start date: May 11, 2022
• Est. completion date: December 2031

Study information

• Verified date: October 2023
• Source: Medeor Therapeutics, Inc.
• Contact: Lenuta Micsa, MD
• Phone: 646-239-9748
• Email: lmicsa[@]medeortx.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

At the completion of primary follow-up of various Medeor Transplant studies (called parent studies), subjects receiving Medeor's cellular immunotherapy products will be followed annually for up to an additional 84 months (7 years), in order to evaluate for long-term safety.

Description:

Study MDR-105-SAE is intended to be the long-term safety monitoring extension of Medeor's cellular immunotherapy, kidney transplant clinical studies. This Master Protocol has been created in order to establish a single database for all long-term safety data for those subjects that have received Medeor's cellular products. This Master Protocol will provide up to 84 months (7 years) of additional follow-up. Long-term safety of subjects treated with Medeor's cellular immunotherapy has not been assessed. This study will collect the data into a centralized database allowing for continuous monitoring of any important safety signals.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2031
• Est. primary completion date: December 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Able and willing to fully comply with all study procedures and restrictions.

2. Able to understand and provide written, signed, and dated informed consent to participate in the study in accordance with ICH GCP Guideline and all applicable local regulations.

3. Have previously completed a Medeor study and received a Medeor cellular immunotherapy product

Exclusion Criteria:

1. Has any condition or circumstance, which in the opinion of the Investigator would significantly interfere with the subject's protocol compliance or put the subject at increased risk.

2. Unable or unwilling to provide written, signed, and dated informed consent to participate in the study.

3. Has undergone a second organ transplant with an organ derived from an individual other than the donor of the transplant kidney received during a Medeor study.

Related Conditions & MeSH terms

• Immune Tolerance

Intervention

Drug:
• MDR product
Observation of patients previously receiving MDR product(s)

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Medeor Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Endpoints	Incidence of serious adverse events (SAEs), adverse events (AEs) leading to study withdrawal, and hospitalizations.	Through study completion, up to 7 years