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NCT06499896 · ClinicalTrials.gov registry record · Phase 2
Healthy-donor Microbiome MTP-101-C in Steroid Relapse/Refractory Immune-related Cutaneous Adverse Events (irCAEs) and Immune-mediated Colitis (IMC)
A Phase 2 study of Immune-mediated Colitis (IMC) and Immune-related Dermatitis, sponsored by Diwakar Davar.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT06499896: Recruiting Phase 2 study of Immune-mediated Colitis (IMC) and Immune-related Dermatitis, sponsored by Diwakar Davar.
NCT06499896 is a Phase 2 study of Immune-mediated Colitis (IMC) and Immune-related Dermatitis that is actively recruiting participants, run by Diwakar Davar. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06499896, a Phase 2 study of Immune-mediated Colitis (IMC) and Immune-related Dermatitis, is actively recruiting participants, sponsored by Diwakar Davar.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
Multiple retrospective studies suggest that the administration of corticosteroids to treat irAEs is safe, and does not compromise efficacy of ICI therapy in cancer patients. While \~67% of patients respond to corticosteroids, 33% of patients require biologic therapy such as TNFα inhibitors (e.g. infliximab), integrin α4β7 inhibitors (e.g. vedolizumab), or JAK/STAT inhibitors (e.g. tofactinib). This study aims to determine that distinct pathobionts govern the development of irCAE and IMC; and that the administration of hdFMT may reverse steroid-refractory irCAEs or IMC. The use of hdFMT has been shown to be effective in steroid and biologic (TNFα and/or integrin α₄β₇ inhibitor) refractory colitis in PD-1 and/or CTLA-4 ICI treated cancer patients in single-institution case series.
Conditions Studied
Interventions
- BIOLOGICAL MTP-101-C
Study Locations (1)
Pennsylvania
- UPMC Hillman Cancer Center - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2025-01-23 |
| Est. Completion | 2031-09-30 |
| Phase | Phase 2 |
What NCT06499896 shows while recruiting
NCT06499896 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 2 conditions, with Immune-mediated Colitis (IMC) appearing as the primary indexed condition, and to 1 intervention - of which MTP-101-C is the first listed.
NCT06499896 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06499896 about?
NCT06499896 is a clinical study titled "Healthy-donor Microbiome MTP-101-C in Steroid Relapse/Refractory Immune-related Cutaneous Adverse Events (irCAEs) and Immune-mediated Colitis (IMC)". Multiple retrospective studies suggest that the administration of corticosteroids to treat irAEs is safe, and does not compromise efficacy of ICI therapy in cancer patients. While \~67% of patients respond to corticosteroids, 33% of patients require biologic therapy such as TNFα inhibitors (e.g. inf...
What is the current status of trial NCT06499896?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2025-01-23. Estimated completion is 2031-09-30.
What conditions does trial NCT06499896 study?
This clinical trial studies the following conditions: Immune-mediated Colitis (IMC), Immune-related Dermatitis.
What interventions are being tested in trial NCT06499896?
The interventions under investigation include: MTP-101-C (BIOLOGICAL).
Who is sponsoring clinical trial NCT06499896?
This trial is sponsored by Diwakar Davar, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06499896 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06499896's enrollment target sits among peer trials
30 1582nd of 2000 higher than 333 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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