Axatilimab + CAR-T in High-Risk Lymphoma
Age ≥ 18 years
Histologically confirmed large B-cell lymphoma
Presence of one or more high-risk features
Eligible to receive CAR-T according to the FDA label
KPS <60
Second malignancy with a high metastatic potential within 3 years
Active CNS involvement. Treated CNS disease is allowed
Active HBV or HCV infection.
Single group
Axatilimab
DrugDose Level -1: 0.1mg/kg Dose Level +1: 0.3mg/kg Dose Level +2: 1mg/kg Dose Level +3: 3mg/kg
Determine the recommended Phase 2 dose (RP2D) of axatilimab
Determine the recommended Phase 2 dose (RP2D) of axatilimab in combination with CAR T cell therapy by following a fast-track dose escalation design and assessing adverse events, using the CTCAE Version 6, related to axatilimab
Estimate 1 year progression-free survival
Estimate 1 year progression-free survival by assessing disease status at 1 year following CAR T infusion
Estimate overall response rate
Estimate overall response rate (a combination of complete and partial responders) by assessing disease status at 1 year following CAR T infusion
Estimate the overall survival of patients
Estimate the overall survival of patients by following survival status and cause of death for 1 year after CAR T infusion
Evaluate duration of response
Evaluate duration of response by assessing disease status at multiple timepoints (Days +30, 100, 180, and 365) within 1 year after CAR T infusion
Characterize the safety of axatilimab in combination with CAR T therapy
Characterize the safety of axatilimab in combination with CAR T therapy by assessing the incidence of cytokine release syndrome and immune-effector cell associated neurotoxcity syndrome according to ASTCT consensus criteria
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