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Gene Transfer Vector

Cohort 1 - Adolescents for Methylmalonic Acidemia (reiMMAgine Trial)

Q: Is this trial still open to new participants?

Clinicaltrials.gov reveals that this clinical trial has been actively recruiting since December 19th 2022 and the listing was most recently updated on March 9 2023.

Q: Is there any way for me to be involved in this experiment?

Enrollees for this trial must possess methylmalonic acidemia and have to be between 3 years old and 17. As of now, roughly 6 people are being recruited in the study.

Q: Is the age range for this experiment restricted to adults?

To enter this clinical trial, participants must be aged from 3 to 17 years old. 8 trials are available for minors and an additional 4 cater towards elderly individuals over the age of 65.

Q: What is the primary purpose of this trial?

The chief outcome to be evaluated during the 5-year period of follow up is SEL-302's PD Activity. Assessments for secondary outcomes include Area Under Curve (AUC) of sirolimus, frequency and severity of specified clinical events, and World Health Organization Quality of Life Brief Version (WHOQoL-BREF).

Q: Are there any quantifiable statistics regarding the number of subjects involved in this clinical trial?

Affirmative. According to the clinicaltrials.gov, this medical trial is presently searching for volunteers. This study was published on December 19th 2022 and had its latest update on March 9th 2023. The research team needs 6 patients at a single location for the experiment to proceed as planned.

Phase 1 & 2

Waitlist Available

Research Sponsored by Selecta Biosciences, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from initial treatment with sel-302 up to 5 years for long-term follow-up.

Awards & highlights

reiMMAgine Trial Summary

This trial will test a gene therapy and a drug to see if it's safe and effective for children with a rare genetic disorder.

Eligible Conditions

Methylmalonic Acidemia

reiMMAgine Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from initial treatment with sel-302 up to 5 years for long-term follow-up.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from initial treatment with sel-302 up to 5 years for long-term follow-up.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from initial treatment with sel-302 up to 5 years for long-term follow-up. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Assess the change in Neutralizing antibody (Nab) titers for MMA-101 with treatment of SEL-110

PD Activity of SEL-302

Safety and tolerability of SEL-302

Secondary outcome measures

Area Under Curve (AUC) of sirolimus

Maximum plasma concentration (Cmax) of sirolimus

Patient outcomes assessed by the frequency and severity of specified clinical events

+2 more

reiMMAgine Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort 2 - ChildrenExperimental Treatment1 Intervention

IV infusion of SEL-302 in all patients on Day 1, followed by two repeat doses of SEL-110 on Day 28 and Day 56 Children ages ≥3 and <12

Group II: Cohort 1 - AdolescentsExperimental Treatment1 Intervention

IV infusion of MMA-101 in the first patient on Day 1 IV infusion of SEL-302 in the second and third patient on Day 1, followed by two repeat doses of SEL-110 on Day 28 and Day 56 Adolescents ages ≥12 and <18

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Selecta Biosciences, Inc.Lead Sponsor

8 Previous Clinical Trials

826 Total Patients Enrolled

National Human Genome Research Institute (NHGRI)NIH

263 Previous Clinical Trials

284,126 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial still open to new participants?

"Clinicaltrials.gov reveals that this clinical trial has been actively recruiting since December 19th 2022 and the listing was most recently updated on March 9 2023."

Answered by AI

Is there any way for me to be involved in this experiment?

"Enrollees for this trial must possess methylmalonic acidemia and have to be between 3 years old and 17. As of now, roughly 6 people are being recruited in the study."

Answered by AI

Is the age range for this experiment restricted to adults?

"To enter this clinical trial, participants must be aged from 3 to 17 years old. 8 trials are available for minors and an additional 4 cater towards elderly individuals over the age of 65."

Answered by AI

What is the primary purpose of this trial?

"The chief outcome to be evaluated during the 5-year period of follow up is SEL-302's PD Activity. Assessments for secondary outcomes include Area Under Curve (AUC) of sirolimus, frequency and severity of specified clinical events, and World Health Organization Quality of Life Brief Version (WHOQoL-BREF)."

Answered by AI

Are there any quantifiable statistics regarding the number of subjects involved in this clinical trial?

"Affirmative. According to the clinicaltrials.gov, this medical trial is presently searching for volunteers. This study was published on December 19th 2022 and had its latest update on March 9th 2023. The research team needs 6 patients at a single location for the experiment to proceed as planned."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of SEL-302 in Pediatric Subjects With MMA

2022. "A Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of SEL-302 in Pediatric Subjects With MMA". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05778877.