Trial · NCT05778877
A Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of SEL-302 in Pediatric Subjects With MMA
NCT05778877, Phase 1, Phase 2, Withdrawn, Selecta Biosciences, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of SEL-302 in Pediatric Subjects With MMA. Trials, record NCT05778877. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05778877
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of SEL-302 in Pediatric Subjects With MMA
- NCT number
- NCT05778877
- Status
- Withdrawn
- Phases
- Phase 1, Phase 2
- Enrollment
- 0 participants, actual
- Lead sponsor
- Selecta Biosciences, Inc.
- Conditions
- Methylmalonic Acidemia (MMA)
- Interventions
- SEL-302
- First posted
- 2023-03-21
- Last updated
- 2024-09-24
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety and tolerability of SEL-302 | From the initial administration of SEL-302 up to 5 years for long-term follow-up. | Incidence and severity of all adverse events (AEs), treatment emergent AEs (TEAEs), and serious adverse events (SAEs) and their relationship to SEL-302 (MMA-101 or SEL-110) Time Frame: From the initial administration of SEL-302 up to 5 years for long-term follow-up. |
| Primary | PD Activity of SEL-302 | From initial treatment with SEL-302 up to 5 years for long-term follow-up. | Measure the change in sMMA levels at Day 84 (interim endpoint for safety assessment) and at the end of the 1-year study period (primary endpoint) and assessed yearly during the 4 years of long-term follow-up. |
| Primary | PD Activity of SEL-302 | From initial treatment with SEL-302 up to 5 years for long-term follow-up. | Measure the change in the 1-13C sodium POBT at Day 84 (interim endpoint for safety assessment) and at the end of the 1-year study period (primary endpoint) and assessed yearly during the 4 years of long-term follow-up. |
| Primary | Assess the change in Neutralizing antibody (Nab) titers for MMA-101 with treatment of SEL-110 | From initial treatment with SEL-302 up to 5 years for long-term follow-up. | Measure Nab serum titers from baseline at multiple timepoints following treatment on Day 28, Day 56, and Day 84. |
| Secondary | Maximum plasma concentration (Cmax) of sirolimus | From initial treatment with SEL-302 up to 84 days following administration of SEL-110. | Measuring the Cmax of sirolimus at the first, second, and third dose of SEL-110. Time Frame: From initial treatment with SEL-302 up to 84 days following administration of SEL-110. |
| Secondary | Area Under Curve (AUC) of sirolimus | From initial treatment with SEL-302 up to 84 days following administration of SEL-110. | Measuring the AUC of sirolimus at the first, second, and third dose of SEL-110. |
| Secondary | Patient outcomes assessed by the frequency and severity of specified clinical events | From initial treatment with SEL-302 up to 5 years for long-term follow-up. | Recording of patient outcomes regarding metabolic crisis in need of sick-day dietary modifications, hospitalization, and need for referral for liver, kidney, or liver/kidney transplant. |
| Secondary | World Health Organization Quality of Life Brief Version (WHOQoL-BREF) | From initial treatment with SEL-302 for up to 5 years for long-term follow-up. | Assess the change from baseline in patient-reported quality of life measures using the WHOQoL-BREF (on a number scale of 0 to 100, with lower indicating a worse outcome). |
| Secondary | Zarit Burden Interview | From initial treatment with SEL-302 for up to 5 years for long-term follow-up. | Assess the change from baseline in patient-reported quality of life measures using the Zarit Burden Interview (on a number scale from 0 to 48, with higher indicating a greater burden) |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05778877
GET https://conductscience.org/api/trials/v1/NCT05778877/registered