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CART123 + Ruxolitinib in Relapsed/Refractory AML

NCT06768476 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-01-16

No results posted yet for this 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.

Conditions

  • Relapsed AML
  • Refractory AML

Interventions

BIOLOGICAL

CART123 Cells

1.3x10\^8 CART123 cells

DRUG

Ruxolitinib 10 MG

Twice Daily

DRUG

Ruxolitinib 5 MG

Twice Daily

Sponsors & Collaborators

Principal Investigators

  • Saar Gill, MD, PhD · University of Pennsylvania

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-28
Primary Completion
2045-03-31
Completion
2045-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06768476 on ClinicalTrials.gov