CART123 + Ruxolitinib in Relapsed/Refractory AML

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT06768476
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Refractory AML
  • Relapsed AML

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Feb 28, 2025
Status verified
Jan 2026
Primary completion
Mar 31, 2045
Completion
Mar 31, 2045

Study Design

Enrollment
12 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: DL1
    * LD Chemo: Day -6 to Day -4 (±1d) * Ruxolitinib: Daily beginning on Day -6 (±1d) through D14 post CART123 infusion. * CART123 Cells: Single infusion on Day 0
  • Experimental: Arm A: DL-1
    * LD Chemo: Day -6 to Day -4 (±1d) * Ruxolitinib: Daily beginning on Day -6 (±1d) through D14 post CART123 infusion. * CART123 Cells: Single infusion on Day 0
  • Experimental: Arm B: DL-1
    * LD Chemo: Day -6 (-1d) to Day -2 (-1d) * Venetoclax: Day -6 (-1d) through Day +7 - Day +14 post-CART123 infusion * Ruxolitinib: Daily beginning on Day -1 through Day +7 post CART123 infusion. * CART123 Cells: Single infusion on Day 0

Primary Outcome Measure

Evaluate the safety of CART123 cells when given in combination with ruxolitinib [ Time Frame: 15 Years ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of PennsylvaniaPhiladelphiaPennsylvania19104-

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By research site
University of Pennsylvania· Philadelphia, PA

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