A Phase 1/2 Multi-Center Study Evaluating the Safety and Efficacy of KTE-X19 in Pediatric and Adolescent Subjects with Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia or Relapsed/Refractory BCell Non Hodgkin Lymphoma (ZUMA-4)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509440-97-00

Acronym

KTE-C19-104

Enrollment

Registered

2024-09-23

Start date

2018-09-25

Completion date

Unknown

Last updated

2025-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (r/r ALL) Relapsed/Refractory B-cell non-Hodgkin lymphoma (r/r NHL)

Brief summary

Phase 1: Incidence of adverse events (AEs) defined as dose-limiting toxicities (DLTs)., Phase 2: a) ALL Cohort: Overall complete remission rate (CR + CRi) per independent review. B)NHL Cohort: ORR per investigator assessment

Detailed description

ALL cohort: • Overall complete remission rate (CR + CRi) per investigator assessment, Rate of CR within 3 months per independent review, Duration of remission (DOR), Minimal residual disease (MRD) negative rate, Allogeneic SCT rate, Overall survival (OS), Relapsed-free survival (RFS), Incidence of AEs and Common Terminology Criteria for Adverse Events (CTCAE) grade changes in safety laboratory values, Incidence of anti-KTE-X19 antibodies in blood, Changes over time in patient-reported outcome (PRO) scores (Phase 2 only), NHL cohort: • DOR, OS, Progression-free survival (PFS), Incidence of AEs and CTCAE grade changes in safety laboratory values, Incidence of anti-KTE-X19 antibodies in blood, Changes over time in PRO scores (Phase 2 only)

Interventions

DRUGTecartus 0.4 - 2 x 10e8 cells dispersion for infusion

Eligibility

Sex/Gender

All

Age

0 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Phase 1: Incidence of adverse events (AEs) defined as dose-limiting toxicities (DLTs)., Phase 2: a) ALL Cohort: Overall complete remission rate (CR + CRi) per independent review. B)NHL Cohort: ORR per investigator assessment	—

Secondary

Measure	Time frame
ALL cohort: • Overall complete remission rate (CR + CRi) per investigator assessment, Rate of CR within 3 months per independent review, Duration of remission (DOR), Minimal residual disease (MRD) negative rate, Allogeneic SCT rate, Overall survival (OS), Relapsed-free survival (RFS), Incidence of AEs and Common Terminology Criteria for Adverse Events (CTCAE) grade changes in safety laboratory values, Incidence of anti-KTE-X19 antibodies in blood, Changes over time in patient-reported outcome (PRO) scores (Phase 2 only), NHL cohort: • DOR, OS, Progression-free survival (PFS), Incidence of AEs and CTCAE grade changes in safety laboratory values, Incidence of anti-KTE-X19 antibodies in blood, Changes over time in PRO scores (Phase 2 only)	—

Measure

Time frame

—

Countries

Czechia, France, Germany, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026