OncoMatch/Clinical Trials/NCT06553872
Phase 2 Open Label Randomized Study of Pirtobrutinib and Brexucabtagene Autoleucel in R/R MCL
Is NCT06553872 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Pirtobrutinib and Brexucabtagene Autoleucel for mantle cell lymphoma.
Treatment: Pirtobrutinib · Brexucabtagene Autoleucel — 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).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Other
Cancer type
Non-Hodgkin Lymphoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: pirtobrutinib (pirtobrutinib)
Exception: 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 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.
Cannot have received: pirtobrutinib (pirtobrutinib)
Patients who have previously discontinued pirtobrutinib due to disease progression, intolerance, or toxicity.
Cannot have received: investigational agent
Patients who are currently receiving or who have received any investigational study agent ≤4 weeks prior to screening visit are ineligible.
Cannot have received: CAR-T cell therapy
Prior treatment with chimeric antigen receptor (CAR) T-cell therapy.
Lab requirements
Blood counts
Platelets >= 50 x 10^9/L; Hemoglobin >= 8g/dL; Absolute Neutrophil Count >=1.0 x 10^9/L
Kidney function
Creatinine clearance >= 30 mL/minute based on Cockcroft-Gault formula
Liver function
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
Cardiac function
Cardiac LVEF >=40% confirmed by ECHO/multigated analysis; Adequate coagulation, defined as aPTT or PTT and PT or INR not greater than 1.5 x ULN
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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Stanford Cancer Center · Stanford, California
- Univ of Miami - Sylvester Comprehensive Cancer Center · Miami, Florida
- Moffitt Cancer Center · Tampa, Florida
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06553872 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior pirtobrutinib, pirtobrutinib, investigational agent disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages