Diffuse Large B Cell Lymphoma (DLBCL), Follicular Grade 3 Lymphoma, High-grade B-cell Lymphoma (HGBCL), High-Grade B-Cell Lymphoma, Nos, PMBCL, Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma
Conditions
Brief summary
Axatilimab + CAR-T in High-Risk Lymphoma
Interventions
DRUGAxatilimab
Dose Level -1: 0.1mg/kg Dose Level +1: 0.3mg/kg Dose Level +2: 1mg/kg Dose Level +3: 3mg/kg
Sponsors
Northside Hospital, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to No maximum
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine the recommended Phase 2 dose (RP2D) of axatilimab | 1 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 survival | 1 year | Estimate 1 year progression-free survival by assessing disease status at 1 year following CAR T infusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Estimate overall response rate | 1 year | 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 | 1 year | 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 | 1 year | 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 | 1 year | 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 |
Countries
United States
Contacts
CONTACTJoseph Maakaron, MD
CONTACTCaitlin Guzowski, MBA, MHA, CCRC
Outcome results
None listed