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NOT YET RECRUITING
NCT07464951
PHASE1

CART123 Cells With or Without Ruxolitinib in Relapsed/Refractory Acute Myeloid Leukemia

Sponsor: Stephan Grupp MD PhD

View on ClinicalTrials.gov

Summary

This study is designed to evaluate the safety and effectiveness of CART123 cells either alone or when combined with ruxolitinib in pediatric and young adult subjects with relapsed or refractory AML. Subjects will be enrolled into one of two treatment cohorts: subjects who will receive CART123 alone (Cohort A) or subjects who will receive CART123 in combination with ruxolitinib (Cohort B).

Official title: Phase 1 Trial of Autologous CD123-Directed CAR T-Cells (CART123) as Monotherapy or in Combination With Ruxolitinib in Relapsed/Refractory Acute Myeloid Leukemia

Key Details

Gender

All

Age Range

0 Years - 29 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-04-01

Completion Date

2030-04-30

Last Updated

2026-03-11

Healthy Volunteers

No

Interventions

BIOLOGICAL

Anti-CD123 LV redirected T cells (CART123)

CART123 cells: lentivirally transduced T cells expressing anti-CD123 chimeric antigen receptors expressing tandem TCRζ and 4-1BB (TCRζ /4-1BB) costimulatory domains.

DRUG

Ruxolitinib (JAKAVI®)

Ruxolitinib: an orally administered janus-activated kinase (JAK) inhibitor that selectively inhibits JAK1 and JAK2.

Locations (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States