Mantle Cell LymphomaPhase 2NCT06553872
Phase 2 Open Label Randomized Study of Pirtobrutinib and Brexucabtagene Autoleucel in R/R MCL
A Phase 2 study testing Pirtobrutinib and Brexucabtagene Autoleucel in people with Mantle Cell Lymphoma, run by H. Lee Moffitt Cancer Center and Research Institute at 3 sites in United States.
Trial summary
This is a phase 2, open-label, randomized, multicenter clinical trial in patients with relapsed/refractory mantle cell lymphoma (R/R MCL) who meet the criteria for standard-of-care FDA label for CD19 CAR T-cell therapy with brexucabtagene autoleucel (brexu-cel). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mantle Cell Lymphoma
- What is being tested?
- Pirtobrutinib and Brexucabtagene Autoleucel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- 23 Aug 2024to Aug 2029
- 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
- Patients with a histologically confirmed diagnosis of mantle cell lymphoma (MCL) will be eligible.
- Adult males or females who are 18 years of age or older at time of signing informed consent.
- Must have ability to comprehend and the willingness to sign written informed consent for study participation.
- Eligible to receive CAR T-cell therapy (Brexucabtagene autoleucel) for MCL by the standard of care label, which states: "TECARTUS or Brexucabtagene autoleucel is a CD19-directed genetically modified autologous T-cell immunotherapy indicated for the treatment of: Adult patients with relapsed or refractory mantle cell lymphoma (MCL)"
- ECOG performance status 0 to 2.
- Patients are required to have the following washout periods prior to leukapheresis. In addition, prior treatment-related AEs must have recovered to Grade ≤ 1 with the exception of alopecia and Grade 2 peripheral neuropathy.
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- Targeted agents (i.e. BTK inhibitors), investigational agents, therapeutic monoclonal antibodies or cytotoxic chemotherapy: 5 half-lives or 2 weeks, whichever is shorter
- Antibody-drug conjugates (ADC): 10 weeks
- Radiation therapy: Broad field radiation (≥ 30% of the bone marrow or whole brain radiotherapy): 14 days. Palliative limited field radiation: 7 days. Note: In the case of known central nervous system (CNS) involvement by systemic lymphoma: Patients with previous treatment for CNS involvement who are neurologically stable and without evidence of disease may be eligible if a compelling clinical rationale is provided by the Investigator and with documented Sponsor approval.
- Bendamustine or other purine analogues: 3 months.
- Corticosteroids: 5 days
- The effects of Pirtobrutinib on the developing human fetus are unknown. For this reason and because other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation as outlined in criteria below:
- Men must agree to take appropriate precautions to avoid fathering children (with at least 99% certainty) from screening through safety follow up and must refrain from donating sperm during this period. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the participants in their understanding confirmed.
- Willingness of women of reproductive potential and their partners to observe highly effective birth control methods for the duration of treatment and for 1 month following the last dose of study treatment (see Section 4.3 and Section 4.4 for further details)
- Women of childbearing potential must have a negative serum pregnancy test at screening and before the first dose of pirtobrutinib and must agree to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from screening through safety follow up. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the participants and their understanding confirmed.
- Women of non-childbearing potential (i.e. surgically sterile with a hysterectomy and/or bilateral oophorectomy OR >= 12 months of amenorrhea) are eligible.
- Patients must meet the following laboratory parameters at screening:
- Hematology (criteria the same regardless of bone marrow involvement; must be independent of transfusions and G-CSF support within 7 days of assessment)
- Platelets >= 50 x 10^9/L
- Hemoglobin >= 8g/dL
- Absolute Neutrophil Count >=1.0 x 10^9/L
- Hepatic
- ALT < 2.5 x ULN for age, <5 x ULN in the presence of liver metastases
- AST < 2.5 x ULN for age, <5 x ULN in the presence of liver metastases
- Total bilirubin < 1.5 x ULN or <3 x ULN in the presence of documented Gilbert's syndrome unconjugated hyperbilirubinemia)
- Renal Creatinine clearance >= 30 mL/minute based on Cockcroft-Gault formula.
- Cardiopulmonary Cardiac LVEF >=40% confirmed by ECHO/multigated analysis
- Adequate pulmonary function <= Grade 2 dyspnea and <= Grade 2 hypoxia per CTCAE v5.0.
- Adequate coagulation, defined as activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) and prothrombin (PT) or (international normalized ratio (INR) not greater than 1.5 x ULN.
Who cannot join
- Patients who have previously received treatment with pirtobrutinib for >2 months prior to study enrollment are ineligible. Patients who are relapsed or refractory and then received less than 2 months of pirtobrutinib as "holding therapy" while awaiting CAR T-cell therapy evaluation, and who did not demonstrate disease progression while on pirtobrutinib holding therapy, are eligible.
- Patients who have previously discontinued pirtobrutinib due to disease progression, intolerance, or toxicity.
- Patients who are currently receiving or who have received any investigational study agent ≤4 weeks prior to screening visit are ineligible.
- Prior treatment with chimeric antigen receptor (CAR) T-cell therapy.
- Participants with clinically significant or uncontrolled cardiac disease, including unstable angina or acute coronary syndrome within the past 2 months prior to randomization, history of myocardial infarction within 3 months prior to randomization, documented LVEF by any method of ≤ 40% in the 12 months prior to randomization, or ≥ Grade 3 NYHA functional classification system of heart failure.
- Uncontrolled or symptomatic arrhythmias, including prolongation of the QT interval corrected for heart rate (QTcF) > 470 msec. QTcF is calculated using Fridericia's Formula (QTcF): QTcF = QT/(RR0.33). Correction of suspected drug induced QTcF prolongation can be attempted at the investigator's discretion and only if clinically safe to do so with either discontinuation of the offending drug or switch to another drug not known to be associated with QTcF prolongation. Correction for underlying bundle branch block (BBB) allowed. Note: Patients with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker
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- Evidence of active uncontrolled/untreated infection (viral, bacterial, fungal, opportunistic) of any origin.
- Participants with active immunologic or inflammatory/autoimmune disease affecting the CNS, and unrelated to their disease under study or previous treatment.
- Patients with active CNS involvement of Mantle Cell Lymphoma. A history of CNS Mantle Cell Lymphoma is allowed, as long as it has cleared, and the patient is able to comply with study procedures. Patients with previous treatment for CNS involvement who are neurologically stable and without evidence of disease may be eligible with documented Sponsor approval.
- Known positive Human immunodeficiency virus (HIV) status. For patients with unknown HIV status, HIV testing will be performed at Screening and result must be negative for enrollment.
- Hepatitis B virus (HBV): Patients with positive hepatitis B surface antigen (HBsAg) are excluded. Patients with positive hepatitis B core antibody (anti-HBc) and negative HBsAg require a negative hepatitis B polymerase chain reaction (PCR) evaluation before randomization. Patients who are HBV DNA PCR positive will be excluded. Patients who are HBV DNA PCR negative with positive anti-HBc require prophylaxis against Hepatitis B reactivation (see Section 6.4 "General Guidance for Hepatic Monitoring").
- Hepatitis C virus (HCV): positive hepatitis C antibody. If positive hepatitis C antibody result, patient will need to have a negative result for hepatitis C ribonucleic acid (RNA) before randomization. Patients who are hepatitis C RNA positive will be excluded.
- Known active cytomegalovirus (CMV) infection. Unknown or negative status are eligible.
- Participants who require the concurrent use of chronic systemic steroids or immunosuppressant medications. Steroids should not be given within 5 days prior to leukapheresis. Concomitant bridging steroids (section 6.6) are allowed after leukapheresis.
- Known hypersensitivity or severe reaction to pirtobrutinib, similar compounds, or excipients.
- Participants who have not recovered from adverse events (AEs) due to prior anticancer therapy (i.e., have residual toxicities > Grade 1), with the exception of stable Grade 2 peripheral neuropathy and/or any grade alopecia.
- Pregnant or nursing (breast-feeding) women are excluded from this study because there is an unknown but potential risk to using pirtobrutinib in pregnant or nursing women. Patients are excluded if they are pregnant or plan to become pregnant during the study or within 1 year of the last dose of study treatment. Patients are also excluded if they are lactating or plan to breastfeed during the study or within 1 week of the last dose of study treatment. Please see Section 4.3 and Section 4.4 for General Guidance for Women of Child Bearing Potential and/or Use of Contraceptive Methods.
- Any condition that would, in the investigator's judgement, interfere with full participation in the study, including administration of pirtobrutinib and attending required study visits (if outpatient); pose a significant risk to the participant; or interfere with interpretation of study data.
- Inability of the participant to swallow and retain oral medication. Or, if there is clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal (GI) absorption of the study drug.
- Patients who experienced a major bleeding event or grade ≥ 3 arrhythmia on prior treatment with a BTK inhibitor. NOTE: Major bleeding is defined as bleeding having one or more of the following features: potentially life-threatening bleeding with signs or symptoms of hemodynamic compromise; bleeding associated with a decrease in the hemoglobin level of at least 2g per deciliter; or bleeding in a critical area or organ (e.g., retroperitoneal, intraarticular, pericardial, epidural, or intracranial bleeding or intramuscular bleeding with compartment syndrome)
- Major surgery within 4 weeks prior to enrollment.
- History of a previously diagnosed hereditary bleeding disorder.
- Patients requiring therapeutic anticoagulation with warfarin or another vitamin K antagonist.
- Active second malignancy unless in remission and with life expectancy > 2 years.
- Vaccination with live vaccine within 28 days prior to randomization.
- History of stroke or intracranial hemorrhage within 6 months of enrollment.
- History of allogeneic or autologous stem cell transplant within 60 days of enrollment, presence of either of the following regardless of prior stem cell transplant timing: active graft vs. host disease; cytopenias from incomplete blood cell count recovery post-transplant.
- Active uncontrolled autoimmune cytopenia, including autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura for which new therapy was introduced or existing therapy was escalated within the 4 weeks prior to study enrollment to maintain adequate blood counts.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Univ of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Jay Spiegel, MD, 305-243-5302
Jay Spiegel, MD
- Not yet recruiting
Stanford Cancer Center
Stanford, California, 94305
Saurabh Dahiya, MD, 650-724-4155
Saurabh Dahiya, MD
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Ruthie Chae, 813-745-3425, ruthie.chae@moffitt.org
Michael Jain, MD, PhD
About this study
Official title: A Phase 2, Open-Label, Randomized Study of Pirtobrutinib and Brexucabtagene Autoleucel in Patients With Relapsed or Refractory Mantle Cell Lymphoma
This is a phase 2, open-label, randomized, multicenter clinical trial in patients with relapsed/refractory mantle cell lymphoma (R/R MCL) who meet the criteria for standard-of-care FDA label for CD19 CAR T-cell therapy with brexucabtagene autoleucel (brexu-cel).
- Conditions
- Mantle Cell Lymphoma
- Being tested
- Pirtobrutinib, Brexucabtagene Autoleucel
- Medical subject headings
- Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PirtobrutinibDrug
Also called Jaypirca
Pirtobrutinib is a non-covalent BTKi that has preserved activity in the presence of mutations that drive BTKi resistance.
Brexucabtagene AutoleucelDrug
Also called Tecartus
Brexucabtagene autoleucel is an autologous CD19-directed chimeric antigen receptor (CAR) T-cell therapy (brexu-cel).
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Participants will recieve pirtobrutinib as bridging therapy from day -27 to day -7. Participants randomized to Arm A (n=30) will continue to receive concurrent pirtobrutinib ("con-pirto"), starting at day -6 and continued until 1-year post-CD19 CAR T-cell therapy with brexucel. Receives: Drug: Pirtobrutinib; Drug: Brexucabtagene Autoleucel |
| Arm B | Experimental | Participants will recieve pirtobrutinib as bridging therapy from day -27 to day -7. Participants on Arm B (n=30) will discontinue pirtobrutinib after day -7 and will not receive concurrent pirtobrutinib ("con-none") between day -6 and 1-year post-CD19 CAR T-cell therapy. Receives: Drug: Pirtobrutinib; Drug: Brexucabtagene Autoleucel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) - Historical comparison
The one-sample log-rank test will be used to determine if there's a statistically significant difference in PFS in patients treated on this trial of pirto plus brexucel compared to a historical control.
Measured: 12 months
Progression-free survival (PFS) - Comparison between arm A and arm B
The one-sample log-rank test will be used to determine if there's a statistically significant difference in PFS in patients treated with concurrent pirtobrutinib ("con-pirto") versus patients treated with no concurrent pirtobrutinib ("con-none").
Measured: 12 months
Secondary outcomes (4)
Severe ICANS
Number of participants experiencing severe ICANS (grade 3 or higher by ASTCT criteria) in the first 60 days after CAR T infusion.
Measured: Up to 60 days post CAR T
Severe CRS
Number of participants experiencing severe CRS (grade 3 or higher by ASTCT criteria) in the first 60 days after CAR T infusion.
Measured: Up to 60 days post CAR T
Overall Response Rate (ORR)
Best Overall Response Rate (ORR) by Lugano Criteria in the full cohort compared to the historical control, and comparing between Arm A and Arm B.
Measured: Up to 48 months
Overall survival (OS)
Overall survival (OS) of patients treated with pirtobrutinib with brexu-cel in the full cohort compared to the historical control, and comparing between Arm A and Arm B.
Measured: Up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start23 Aug 2024
- Primary completionAug 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mantle Cell LymphomaStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Bankhead-Coley Florida Biomedical Research Program, Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Michael Jain, MD, PhD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06553872
- Sponsor's protocol ID
- MCC-22557
- Other IDs
- J2N-US-I010
- Status last verified
- Sep 2026
- First submitted
- 12 Aug 2024
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-Label, Randomized Study of Pirtobrutinib and Brexucabtagene Autoleucel in Patients With Relapsed or Refractory Mantle Cell Lymphoma
- ClinicalTrials.gov ID
- NCT06553872
- Acronym / sponsor ID
- MCC-22557
- Conditions
- Mantle Cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Bankhead-Coley Florida Biomedical Research Program, Eli Lilly and Company
- Study start
- 23 Aug 2024 (actual)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 14 Aug 2024 (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 phase 2, open-label, randomized, multicenter clinical trial in patients with relapsed/refractory mantle cell lymphoma (R/R MCL) who meet the criteria for standard-of-care FDA label for CD19 CAR T-cell therapy with brexucabtagene autoleucel (brexu-cel).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Pirtobrutinib, Drug: Brexucabtagene AutoleucelParticipants will recieve pirtobrutinib as bridging therapy from day -27 to day -7. Participants randomized to Arm A (n=30) will continue to receive concurrent pirtobrutinib ("con-pirto"), starting at day -6 and continued until 1-year post-CD19 CAR T-cell therapy with brexucel. |
| Arm B | Experimental | Drug: Pirtobrutinib, Drug: Brexucabtagene AutoleucelParticipants will recieve pirtobrutinib as bridging therapy from day -27 to day -7. Participants on Arm B (n=30) will discontinue pirtobrutinib after day -7 and will not receive concurrent pirtobrutinib ("con-none") between day -6 and 1-year post-CD19 CAR T-cell therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Patients with a histologically confirmed diagnosis of mantle cell lymphoma (MCL) will be eligible.
- Adult males or females who are 18 years of age or older at time of signing informed consent.
- Must have ability to comprehend and the willingness to sign written informed consent for study participation.
- Eligible to receive CAR T-cell therapy (Brexucabtagene autoleucel) for MCL by the standard of care label, which states: "TECARTUS or Brexucabtagene autoleucel is a CD19-directed genetically modified autologous T-cell immunotherapy indicated for the treatment of: Adult patients with relapsed or refractory mantle cell lymphoma (MCL)"
- ECOG performance status 0 to 2.
Key exclusion criteria (28 listed)
- Patients who have previously received treatment with pirtobrutinib for >2 months prior to study enrollment are ineligible. Patients who are relapsed or refractory and then received less than 2 months of pirtobrutinib as "holding therapy" while awaiting CAR T-cell therapy evaluation, and who did not demonstrate disease progression while on pirtobrutinib holding therapy, are eligible.
- Patients who have previously discontinued pirtobrutinib due to disease progression, intolerance, or toxicity.
- Patients who are currently receiving or who have received any investigational study agent ≤4 weeks prior to screening visit are ineligible.
- Prior treatment with chimeric antigen receptor (CAR) T-cell therapy.
- Participants with clinically significant or uncontrolled cardiac disease, including unstable angina or acute coronary syndrome within the past 2 months prior to randomization, history of myocardial infarction within 3 months prior to randomization, documented LVEF by any method of ≤ 40% in the 12 months prior to randomization, or ≥ Grade 3 NYHA functional classification system of heart failure.
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 |
|---|---|---|
| PirtobrutinibAlso: JaypircaPirtobrutinib is a non-covalent BTKi that has preserved activity in the presence of mutations that drive BTKi resistance. | Drug | Arm A, Arm B |
| Brexucabtagene AutoleucelAlso: TecartusBrexucabtagene autoleucel is an autologous CD19-directed chimeric antigen receptor (CAR) T-cell therapy (brexu-cel). | Drug | Arm A, Arm B |
Primary outcome
Progression-free survival (PFS) - Historical comparison
Time frame: 12 months
The one-sample log-rank test will be used to determine if there's a statistically significant difference in PFS in patients treated on this trial of pirto plus brexucel compared to a historical control.
Progression-free survival (PFS) - Comparison between arm A and arm B
Time frame: 12 months
The one-sample log-rank test will be used to determine if there's a statistically significant difference in PFS in patients treated with concurrent pirtobrutinib ("con-pirto") versus patients treated with no concurrent pirtobrutinib ("con-none").
4 secondary outcomes
Severe ICANS
Time frame: Up to 60 days post CAR T
Severe CRS
Time frame: Up to 60 days post CAR T
Overall Response Rate (ORR)
Time frame: Up to 48 months
Overall survival (OS)
Time frame: Up to 48 months
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 23 Sep 2026.
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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.
Michael Jain, MD, PhD principal investigator
Moffitt Cancer Center
3 sites 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 Brexucabtagene Autoleucel in people with Mantle Cell Lymphoma, run by H. Lee Moffitt Cancer Center and Research Institute at 3 sites in United States.
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 29 inclusion and 28 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: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Contact Ruthie Chae (813-745-3425, ICETtrials@moffitt.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) - Historical comparison (time frame: 12 months). The study lists 2 primary outcomes in all. 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 23 Sep 2026.