Relapsed or Refractory B-cell LymphomaPhase 2NCT07622784
Pirtobrutinib Maintenance After CAR-T Therapy in Relapsed or Refractory B-Cell Lymphoma
A Phase 2 study testing Pirtobrutinib and Second Infusion of Commercial Anti-CD19 CAR-T Cells in people with Relapsed or Refractory B-cell Lymphoma, run by Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed or Refractory B-cell Lymphoma
- What is being tested?
- Pirtobrutinib and Second Infusion of Commercial Anti-CD19 CAR-T Cells
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Jun 2026to Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Sun yat-sen university cancer center
Guangzhou, Guangdong, 510060
Principal investigator, 0086-20-87342823, caiqq@sysucc.org.cn
About this study
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
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
- Being tested
- Pirtobrutinib, Second Infusion of Commercial Anti-CD19 CAR-T Cells
- Medical subject headings
- Recurrence, Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PirtobrutinibDrug
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 CellsBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Pirtobrutinib; Biological: Second Infusion of Commercial Anti-CD19 CAR-T Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 6 months after initiation of pirtobrutinib maintenance therapy
Secondary outcomes (8)
Best complete response rate (bCRR)
bCRR is defined as the proportion of patients whose best response is complete response according to the Lugano 2014 criteria.
Measured: Up to 24 months
Best objective response rate (bORR)
bORR is defined as the proportion of patients whose best response is complete response or partial response according to the Lugano 2014 criteria.
Measured: Up to 24 months
Objective response rate (ORR)
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.
Measured: At 6 months after initiation of pirtobrutinib maintenance therapy
Duration of complete response (DoCR)
DoCR is defined as the time from the first documented complete response to disease progression or death from any cause, whichever occurs first.
Measured: Up to 24 months
Duration of response (DOR)
DOR is defined as the time from the first documented response to disease progression or death from any cause, whichever occurs first.
Measured: Up to 24 months
Progression-free survival (PFS)
PFS is defined as the time from enrollment to disease progression or death from any cause, whichever occurs first.
Measured: Up to 24 months
Overall survival (OS)
OS is defined as the time from enrollment to death from any cause.
Measured: Up to 24 months
Incidence of adverse events (AEs) and serious adverse events (SAEs)
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.
Measured: Up to 30 days after the last dose of pirtobrutinib
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory B-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qingqing Cai, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07622784
- Sponsor's protocol ID
- T2026-006
- Status last verified
- May 2026
- First submitted
- 28 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07622784
- Acronym / sponsor ID
- T2026-006
- Conditions
- Relapsed or Refractory B-cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 3 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pirtobrutinib Maintenance After CAR-T Cell Therapy | Experimental | Drug: Pirtobrutinib, Biological: Second Infusion of Commercial Anti-CD19 CAR-T CellsPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PirtobrutinibPirtobrutinib 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. | Drug | Pirtobrutinib Maintenance After CAR-T Cell Therapy |
| Second Infusion of Commercial Anti-CD19 CAR-T CellsA 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. | Biological | Pirtobrutinib Maintenance After CAR-T Cell Therapy |
Primary outcome
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.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pirtobrutinib and Second Infusion of Commercial Anti-CD19 CAR-T Cells in people with Relapsed or Refractory B-cell Lymphoma, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response rate (CRR) (time frame: At 6 months after initiation of pirtobrutinib maintenance therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.