An Open-label, Phase I Trial, With an Expansion Cohort: Macrophage Conditioning to Synergize With CAR-T in High-risk Lymphoma (MAC-SHIFT)
Northside Hospital, Inc.
Summary
Axatilimab + CAR-T in High-Risk Lymphoma
Eligibility
- Age range
- 8+ years
- Sex
- All
- Healthy volunteers
- No
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 a…
Interventions
- DrugAxatilimab
Dose Level -1: 0.1mg/kg Dose Level +1: 0.3mg/kg Dose Level +2: 1mg/kg Dose Level +3: 3mg/kg
Location
- Northside HospitalAtlanta, Georgia