Not yet recruiting NCT07622784
Pirtobrutinib Maintenance After CAR-T Therapy in Relapsed or Refractory B-Cell Lymphoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pirtobrutinib, Second Infusion of Commercial Anti-CD19 CAR-T Cells.
- Who it may be relevant to
- Registry conditions: Relapsed or Refractory B-cell Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
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.
Primary outcome measures
- Complete response rate (CRR) [Time frame: At 6 months after initiation of pirtobrutinib maintenance therapy]
Secondary outcome measures (8)
- Best complete response rate (bCRR) [Time frame: Up to 24 months]
- Best objective response rate (bORR) [Time frame: Up to 24 months]
- Objective response rate (ORR) [Time frame: At 6 months after initiation of pirtobrutinib maintenance therapy]
- Duration of complete response (DoCR) [Time frame: Up to 24 months]
- Duration of response (DOR) [Time frame: Up to 24 months]
- Progression-free survival (PFS) [Time frame: Up to 24 months]
- Overall survival (OS) [Time frame: Up to 24 months]
- Incidence of adverse events (AEs) and serious adverse events (SAEs) [Time frame: Up to 30 days after the last dose of pirtobrutinib]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Sun yat-sen university cancer center — Guangzhou
Identifiers
NCT: NCT07622784 · T2026-006