NCT06144606

Study of KTE-X19 in Minimal Residual Disease (MRD) Positive B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Phase 2 Study of KTE-X19 in Minimal Residual Disease (MRD) Positive B-Cell Acute Lymphoblastic Leukemia (B-ALL)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2 Study is to determine the efficacy and safety rate of B-Cell Acute Lymphoblastic Leukemia (B-ALL) participants in remission with minimal residual disease (MRD) after KTE-X19 CAR T-cell therapy

Conditions

• B-Cell Lymphoblastic Leukemia
• Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
DRUG	Tecartus	Tecartus is a CD19 directed CAR T-cell therapy that utilizes CD28 costimulatory and CD3 zeta stimulatory domains. Tecartus is manufactured from purified autologous T-cells via retroviral transduction with a median time to product release of 13 days.

Timeline

• Start date: 2023-12-26
• Primary completion: 2028-11-15
• Completion: 2028-11-15
• First posted: 2023-11-22
• Last updated: 2026-03-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study