A Phase 2, Open-Label, Multicenter, Basket Study Evaluating the Safety and Efficacy of Brexucabtagene Autoleucel in Adults with Rare B-cell Malignancies (ZUMA-25) – Substudy D - Relapsed/Refractory Hairy Cell Leukemia (HCL)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-501262-21-00

Acronym

KT-US-568-0138-D

Enrollment

Registered

2023-02-13

Start date

2023-04-14

Completion date

2024-06-25

Last updated

2023-05-26

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

Conditions

Relapsed/Refractory Hairy Cell Leukemia

Brief summary

The primary endpoint of ZUMA-25 as per the master protocol is response rates by central assessment as defined in each substudy. The primary end point of Substudy D (HCL) is ORR by central assessment defined as the proportion of subjects who achieve either complete response (CR) or partial response (PR)

Detailed description

The secondary endpoints of ZUMA-25 as per the master protocol are: • CR rate by central assessment as defined in each substudy, • Duration of Response, • Overall Survival, • Progression-free survival, • Time to next treatment defined as the time from enrollment (for Full Analysis Set [FAS]) or brexucabtagene autoleucel infusion (for modified intention to treat [mITT]) to the initiation of subsequent anticancer therapy/treatment, • Time to first response from brexucabtagene autoleucel infusion to the first response as defined in the substudy, The Substudy D (HCL) specific secondary endpoint is ORR by investigator assessment defined as the proportion of subjects who achieve either CR or PR

Interventions

DRUG-

DRUGMETHYLPREDNISOLONE

DRUGFLUDARABINE

DRUGMESNA

DRUGTecartus 0.4 – 2 × 108 cells dispersion for infusion

DRUGCYCLOPHOSPHAMIDE

DRUGDEXAMETHASONE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint of ZUMA-25 as per the master protocol is response rates by central assessment as defined in each substudy. The primary end point of Substudy D (HCL) is ORR by central assessment defined as the proportion of subjects who achieve either complete response (CR) or partial response (PR)	—

Secondary

Measure	Time frame
The secondary endpoints of ZUMA-25 as per the master protocol are: • CR rate by central assessment as defined in each substudy, • Duration of Response, • Overall Survival, • Progression-free survival, • Time to next treatment defined as the time from enrollment (for Full Analysis Set [FAS]) or brexucabtagene autoleucel infusion (for modified intention to treat [mITT]) to the initiation of subsequent anticancer therapy/treatment, • Time to first response from brexucabtagene autoleucel infusion to the first response as defined in the substudy, The Substudy D (HCL) specific secondary endpoint is ORR by investigator assessment defined as the proportion of subjects who achieve either CR or PR	—

Measure

Time frame

—

Countries

Austria, France, Germany, Italy, Netherlands, Spain, Sweden

Outcome results

None listed

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