Relmacabtagene Autoleucel as First-Line Therapy for High-Risk Large B-Cell Lymphoma

Launched by PEKING UNIVERSITY CANCER HOSPITAL & INSTITUTE · Oct 19, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Relmacabtagene Autoleucel for patients with high-risk large B-cell lymphoma, a type of blood cancer. The goal is to see how effective this treatment is in helping patients who have not yet received other therapies. To join the study, participants need to be at least 18 years old and have a confirmed diagnosis of large B-cell lymphoma that is considered high-risk. They should also have good overall health, expected to live for more than 12 weeks, and pass certain health tests related to their blood and organ function.

If someone is eligible and decides to participate, they can expect to receive the new treatment after undergoing a procedure to collect their immune cells. The trial is currently recruiting, and it’s important for potential participants to understand that certain health conditions, like infections or previous treatments for other cancers, may exclude them from joining. Overall, this trial aims to provide valuable information that could lead to better outcomes for patients with this challenging condition.

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Eligibility criteria

• Inclusion Criteria:
• • 1. ≥ 18 years old;
• • 2. Sign on the informed consent;
• • 3. Histologically confirmed large B-cell lymphoma that also meets the definition of high-risk large B-cell lymphoma as a lymphoma International Prognostic Index (IPI) score of 3-5 and/or high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangement (double/triple-hit lymphoma) (DHL/THL) and must be treated with 2 cycles of CD20 monoclonal antibodies combined with anthracyclines. Presence of positive PET assessable lesions (DS score of 4 or 5) as determined by the Lugano criteria (Cheson et al., 2014)；
• • 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• • 5. Expected survival greater than 12 weeks；
• • 6. Adequate organ function：
• • 1. Absolute neutrophil count ≥ 1000/μL；Absolute lymphocyte count ≥ 100/μL； Platelet count ≥ 75,000/μL；Hb ≥ 80g/L；
• • 2. Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance (Cockcroft-Gault formula) \> 50 mL/min (serum creatinine clearance due to lymphoma mass compression should be \> 30 mL/min)；
• • 3. Serum alanine aminotransferase (ALT) ≤ 5 upper limit of normal (ULN) and total bilirubin ≤2ULN（or for subjects with Gilbert's syndrome or lymphoma invading the liver \< 3 ULN）；
• • 4. Baseline oxygen saturation \> 92% on room air；
• • 5. Left ventricular ejection fraction (LVEF) ≥50% assessed by echocardiography or radionuclide activity angiography (MUGA) within 1 month of enrollment；
• • 7. Adequate vascular access for leukapheresis procedure;
• • 8. Women of childbearing potential must agree to use highly effective methods of contraception for at least 28 days prior to lymphocyte clearance chemotherapy through 1 year after Relmacabtagene Autoleucel infusion; Males who have partners of childbearing potential must agree to use an effective barrier contraceptive method for 1 year after Relmacabtagene Autoleucel infusion.
• Exclusion Criteria:
• • 1. Lymphoma involving the central nervous system (CNS)；
• • 2. History of another primary malignancy that has not been in remission for at least 2 years;
• • 3. History of Richter's transformation of chronic lymphocytic leukemia or primary mediastinal B-cell lymphoma；
• • 4. Subjects has HBV, HCV, HIV or syphilis infection at the time of screening;
• • 5. Deep venous thrombosis (DVT)/Pulmonary embolism (PE), or DVT/PE requires anti-coagulation within 3 months prior to signing the ICF;
• • 6. Subjects with uncontrolled systemic fungal, bacterial, viral or other infection;
• • 7. Presence of acute or chronic graft-versus-host disease (GVHD);
• • 8. History of any serious cardiovascular disease or presence of clinically relevant CNS pathology;
• • 9. Pregnant or nursing women;
• • 10. Subjects Received an autologous or allogeneic hematopoietic stem cell transplant；
• • 11. Uncontrolled conditions or unwillingness or inability to follow the procedures required in the protocol;
• • 12. Received CAR T-cell or other genetically-modified T-cell therapy previously；
• • 13. Received live vaccination within 6 weeks prior to lymphocyte clearance chemotherapy；
• • 14. History of severe hypersensitivity reactions to any of the drug ingredients used in this study product.