RecruitingPhase 1NCT07464951

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

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


Sponsor

Stephan Grupp MD PhD

Enrollment

30 participants

Start Date

May 14, 2026

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 0 YearsMax Age: 29 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Anti-CD123 LV redirected T cells (CART123) and a drug called Ruxolitinib (JAKAVI®) for people with acute myeloid leukemia (aml). The study is currently recruiting participants at 1 location. People eligible for this study include aged 0 Years to 29 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAnti-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.

DRUGRuxolitinib (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

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NCT07464951


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