NCT07638982
Axatilimab + CAR-T for High-Risk Lymphoma
Not Yet Recruiting
PHASE1Ages 8+InterventionalTreatmentNorthside Hospital, Inc.Investigator-initiated
~29 participants
Updated 2026-06-10 on ClinicalTrials.gov
What's tested:Axatilimab
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Determine the recommended Phase 2 dose (RP2D) of axatilimab
Measured over 1 year
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesGeorgia1
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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
What this trial measures
- Determine the recommended Phase 2 dose (RP2D) of axatilimab1 year
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 survival1 year
Estimate 1 year progression-free survival by assessing disease status at 1 year following CAR T infusion