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NCT Number: NCT07622784

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

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.

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Key information

Conditions

Relapsed or Refractory B-cell Lymphoma Disease Attributes Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Complete response rate (CRR)

    Time frame: At 6 months after initiation of pirtobrutinib maintenance therapy

    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.

Secondary outcomes

  1. Best complete response rate (bCRR)

    Time frame: Up to 24 months

    bCRR is defined as the proportion of patients whose best response is complete response according to the Lugano 2014 criteria.

  2. Best objective response rate (bORR)

    Time frame: Up to 24 months

    bORR is defined as the proportion of patients whose best response is complete response or partial response according to the Lugano 2014 criteria.

  3. Objective response rate (ORR)

    Time frame: At 6 months after initiation of pirtobrutinib maintenance therapy

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

  4. Duration of complete response (DoCR)

    Time frame: Up to 24 months

    DoCR is defined as the time from the first documented complete response to disease progression or death from any cause, whichever occurs first.

  5. Duration of response (DOR)

    Time frame: Up to 24 months

    DOR is defined as the time from the first documented response to disease progression or death from any cause, whichever occurs first.

  6. Progression-free survival (PFS)

    Time frame: Up to 24 months

    PFS is defined as the time from enrollment to disease progression or death from any cause, whichever occurs first.

  7. Overall survival (OS)

    Time frame: Up to 24 months

    OS is defined as the time from enrollment to death from any cause.

  8. Incidence of adverse events (AEs) and serious adverse events (SAEs)

    Time frame: Up to 30 days after the last dose of pirtobrutinib

    The incidence and severity of adverse events will be assessed and graded according to the National Cancer In Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 3, 2026
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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