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NCT06768476 · ClinicalTrials.gov registry record · Phase 1
CART123 + Ruxolitinib in Relapsed/Refractory AML
A Phase 1 study of Refractory AML and Relapsed AML, sponsored by University of Pennsylvania.
- Active
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT06768476: Active Phase 1 study of Refractory AML and Relapsed AML, sponsored by University of Pennsylvania.
NCT06768476 is a Phase 1 study of Refractory AML and Relapsed AML that is active but no longer recruiting, run by University of Pennsylvania. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06768476, a Phase 1 study of Refractory AML and Relapsed AML, is active but no longer recruiting, sponsored by University of Pennsylvania.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
Phase I, open-label study to assess the safety, feasibility, pharmacokinetics, and preliminary efficacy of CART123 cells given in combination with ruxolitinib in patients with relapsed or refractory acute myeloid leukemia (AML). All subjects will receive a single infusion of CART123 cells following ruxolitinib administration and lymphodepletion. Ruxolitinib dosing will begin at initiation of lymphodepleting chemotherapy (Day -6 ±1d) and continue for up to 14 days post CART123 administration.
Primary Outcome
Type, frequency, severity, and attribution of AEs/SAEs, including the incidence and severity of IEC-associated adverse events.
Conditions Studied
Interventions
- BIOLOGICAL CART123 Cells
- DRUG Ruxolitinib 10 MG
- DRUG Ruxolitinib 5 MG
Study Locations (1)
Pennsylvania
- University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2025-02-28 |
| Est. Completion | 2045-03 |
| Phase | Phase 1 |
What the registry record for NCT06768476 still lists
NCT06768476 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 2 conditions, with Refractory AML appearing as the primary indexed condition, and to 3 interventions - of which CART123 Cells is the first listed.
NCT06768476 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06768476 about?
NCT06768476 is a clinical study titled "CART123 + Ruxolitinib in Relapsed/Refractory AML". Phase I, open-label study to assess the safety, feasibility, pharmacokinetics, and preliminary efficacy of CART123 cells given in combination with ruxolitinib in patients with relapsed or refractory acute myeloid leukemia (AML). All subjects will receive a single infusion of CART123 cells following ...
What is the current status of trial NCT06768476?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2025-02-28. Estimated completion is 2045-03.
What conditions does trial NCT06768476 study?
This clinical trial studies the following conditions: Refractory AML, Relapsed AML.
What interventions are being tested in trial NCT06768476?
The interventions under investigation include: CART123 Cells (BIOLOGICAL), Ruxolitinib 10 MG (DRUG), Ruxolitinib 5 MG (DRUG).
Who is sponsoring clinical trial NCT06768476?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06768476 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
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Where NCT06768476's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
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