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Phase 2 CAR-T Combined With ASCT for High-risk Relapsed/Refractory Large B-cell Lymphoma

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Summary

The NIH has registered a Phase 2 clinical study (NCT07538635) evaluating axicabtagene ciloleucel combined with autologous stem cell transplantation (ASCT) in patients with relapsed/refractory large B-cell lymphoma (LBCL) who have high-risk factors. The trial is prospective, single-arm, single-center, and open-label. Axicabtagene ciloleucel is the sole intervention. ClinicalTrials.gov registrations are informational public listings and do not constitute regulatory approvals or enforceable obligations.

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What changed

NIH has added a new clinical trial registration to ClinicalTrials.gov for a Phase 2 study of axicabtagene ciloleucel combined with ASCT for high-risk relapsed/refractory large B-cell lymphoma. The registration provides the study title, phase, NCT identifier, study type (prospective, single-arm, single-center, open-label), condition (high-risk R/R LBCL), intervention name, and estimated start date of April 20, 2026. No regulatory approval, safety finding, or compliance obligation is associated with this registration entry.

Healthcare providers, clinical investigators, and pharmaceutical companies involved in CAR-T or stem cell transplant programs should treat this as an informational registry entry for awareness purposes only. No compliance action, reporting, or regulatory response is required from this ClinicalTrials.gov listing. Sponsors of competing or complementary trials in this indication space may wish to review the trial protocol for overlap assessment.

Archived snapshot

Apr 21, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

← ClinicalTrials.gov Studies

CAR-T Combined With ASCT in the Treatment of Relapsed/Refractory Large B-cell Lymphoma With High-risk Factors.

Phase 2 NCT07538635 Kind: PHASE2 Apr 20, 2026

Abstract

This is a prospective, single-arm, single-center, open-label clinical study, aiming to evaluate the efficacy and safety of CAR-T combined with ASCT in the treatment of relapsed/refractory large B-cell lymphoma with high-risk factors.

Conditions: High-risk R/R LBCL

Interventions: Axicabtagene Ciloleucel

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Last updated

Classification

Agency
NIH
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Healthcare providers Clinical investigators Pharmaceutical companies
Industry sector
6211 Healthcare Providers
Activity scope
Clinical trial registration CAR-T therapy Stem cell transplantation
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Topics
Pharmaceuticals Public Health

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