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 (May 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
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
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