Axatilimab + CAR-T for High-Risk Lymphoma

An Open-label, Phase I Trial, With an Expansion Cohort: Macrophage Conditioning to Synergize With CAR-T in High-risk Lymphoma (MAC-SHIFT)

Axatilimab + CAR-T in High-Risk Lymphoma

Inclusion Criteria:

• 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
• Measurable disease by CT or PET
• Adequate organ function unless related to lymphoma involvement:
• Pulse oximetry ≥ 92% on room air
• Ejection Fraction ≥ 40%
• ALT/AST < 5x ULN
• Bilirubin < 3 x ULN
• Calculated or measured creatinine Clearance ≥ 30 mL/min

Exclusion Criteria:

• 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.
• Active uncontrolled infections
• Known HIV positive status
• Allogeneic transplant within 100 days of enrollment
• Active acute or chronic graft versus host disease
• History of acute or chronic pancreatitis
• History of myositis