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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 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. The trial reports 1 study location across 1 state.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06499896
The ClinicalTrials.gov registry entry for NCT06499896 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Diwakar Davar, which has 12 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Immune-mediated Colitis (IMC)
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Immune-related Dermatitis
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Pennsylvania
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