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

NCT07622784 | Not Yet Recruiting Phase 2

• 1 other identifier: T2026-006
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Relapsed or Refractory B-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Complete response rate (CRR)

  CRR is defined as the proportion of patients who achieve complete response according to the Lugano 2014 criteria at 6 months after initiation of pirtobrutinib maintenance therapy.

  At 6 months after initiation of pirtobrutinib maintenance therapy

Secondary Outcomes (8)

• Best complete response rate (bCRR)

  Up to 24 months

• Best objective response rate (bORR)

  Up to 24 months

• Objective response rate (ORR)

  At 6 months after initiation of pirtobrutinib maintenance therapy

• Duration of complete response (DoCR)

  Up to 24 months

• Duration of response (DOR)

  Up to 24 months

Study Arms (1)

Pirtobrutinib Maintenance After CAR-T Cell Therapy

EXPERIMENTAL

Patients will receive pirtobrutinib 200 mg orally once daily starting on Day 30 after commercial anti-CD19 CAR-T cell infusion. Pirtobrutinib maintenance therapy will be continued for 6 months unless disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-defined discontinuation criteria occur. Patients who do not achieve complete response after 6 months of maintenance therapy, or who achieve complete response with detectable ctDNA, may receive a second infusion of commercial CAR-T cells at the investigator's discretion.

Drug: Pirtobrutinib; Biological: Second Infusion of Commercial Anti-CD19 CAR-T Cells

Interventions

Pirtobrutinib DRUG

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.

Pirtobrutinib Maintenance After CAR-T Cell Therapy

Second Infusion of Commercial Anti-CD19 CAR-T Cells BIOLOGICAL

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.

Pirtobrutinib Maintenance After CAR-T Cell Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to understand and voluntarily sign the informed consent form.
• Age 18 years or older, male or female.
• Histologically confirmed large B-cell lymphoma, including diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, or transformed follicular lymphoma (tFL).
• Eastern Cooperative Oncology Group performance status of 0 to 2.
• Has received commercial anti-CD19 CAR-T cell therapy, with informed consent obtained before Day 28 after CAR-T cell infusion.
• Prior anti-lymphoma therapy-related adverse events, especially CAR-T-related adverse events, have stabilized and recovered to Grade 1 or lower, except for clinically insignificant toxicities.

You may not qualify if:

• History of other malignancies, except non-melanoma skin cancer without recurrence for more than 3 years, carcinoma in situ, such as cervical, bladder, or breast carcinoma, or follicular lymphoma.
• Prior autologous or allogeneic hematopoietic stem cell transplantation.
• Active or suspected uncontrolled fungal, bacterial, viral, or other infection requiring intravenous treatment. Patients with uncomplicated urinary tract infection or uncomplicated bacterial pharyngitis may be enrolled if responding to active treatment.
• History of immunodeficiency, including human immunodeficiency virus infection; positive treponema pallidum antibody; active hepatitis B virus infection; or active hepatitis C virus infection.
• Current or prior history of benign central nervous system disease, such as seizure, cerebrovascular ischemia or hemorrhage, dementia, cerebellar disease, or any central nervous system-related autoimmune disease.
• Lymphoma involvement of the atrium or ventricle.
• Autoimmune disease requiring systemic immunosuppressive or immunomodulatory therapy within 2 years.
• History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months before enrollment.
• Any comorbidity that may affect or interfere with safety or efficacy assessment.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun yat-sen university cancer center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Recurrence; Lymphoma, B-Cell

Interventions

pirtobrutinib

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chief Physician

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 3, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)