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Relmacabtagene Autoleucel Combined With Autologous Hematopoietic Stem Cell Transplantation, Orelabrutinib, and Sintilimab for Primary Central Nervous System Lymphoma

NCT07198464 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-09-30

No results posted yet for this study

Summary

To evaluate the efficacy and safety of relmacabtagene autoleucel combined with autologous hematopoietic stem cell transplantation, orelabrutinib, and sintilimab as first-line or relapsed/refractory treatment for primary central nervous system diffuse large B-cell lymphoma.

Conditions

  • Primary Central Nervous System Lymphoma (PCNSL)

Interventions

DRUG

Relmacabtagene autoleucel and transplantation

This study enrolled patients with primary central nervous system lymphoma, from whom mononuclear cells and hematopoietic stem cells were collected. Participants receive infusions of hematopoietic stem cells and CAR-T cells, followed by maintenance therapy with orelabrutinib and sintilimab starting on day 15 post-transplantation, for a median duration of up to 6 months and 1 year, respectively.

Sponsors & Collaborators

  • Zhengzhou University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-07
Primary Completion
2029-10-01
Completion
2029-10-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07198464 on ClinicalTrials.gov