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NOT YET RECRUITING
NCT07622784
PHASE2

Pirtobrutinib Maintenance After CAR-T Therapy in Relapsed or Refractory B-Cell Lymphoma

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

Summary

This is a single-arm, open-label, multicenter clinical study to evaluate the efficacy and safety of pirtobrutinib as maintenance therapy in patients with relapsed or refractory B-cell lymphoma after commercial anti-CD19 CAR-T cell therapy.

Official title: A Single-Arm, Open-Label, Multicenter Clinical Study to Evaluate the Efficacy and Safety of Pirtobrutinib as Maintenance Therapy for Relapsed or Refractory B-Cell Lymphoma After CAR-T Cell Therapy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-06

Completion Date

2028-12

Last Updated

2026-06-03

Healthy Volunteers

No

Interventions

DRUG

Pirtobrutinib

Pirtobrutinib will be administered orally at a dose of 200 mg once daily for 6 months, beginning on Day 30 after commercial anti-CD19 CAR-T cell infusion. Dose interruption, dose reduction, or treatment discontinuation will be performed according to protocol-specified toxicity management rules.

BIOLOGICAL

Second Infusion of Commercial Anti-CD19 CAR-T Cells

A second infusion of commercial anti-CD19 CAR-T cells may be administered after completion of 6 months of pirtobrutinib maintenance therapy in selected patients who do not achieve complete response, or who achieve complete response but remain ctDNA-positive, based on investigator assessment and protocol-defined criteria.

Locations (1)

Sun yat-sen university cancer center

Guangzhou, Guangdong, China