Trials / Active Not Recruiting
Active Not RecruitingNCT06768476
CART123 + Ruxolitinib in Relapsed/Refractory AML
Phase I Trial of CART123 Cells Given in Combination With Ruxolitinib in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- Sponsor
- University of Pennsylvania · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CART123 Cells | 1.3x10\^8 CART123 cells |
| DRUG | Ruxolitinib 10 MG | Twice Daily |
| DRUG | Ruxolitinib 5 MG | Twice Daily |
Timeline
- Start date
- 2025-02-28
- Primary completion
- 2045-03-01
- Completion
- 2045-03-01
- First posted
- 2025-01-10
- Last updated
- 2026-01-16
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06768476. Inclusion in this directory is not an endorsement.