Axatilimab + CAR-T for High-Risk Lymphoma

Phase 1Not Yet RecruitingNCT07638982

Northside Hospital, Inc.29 enrolled

Overview

Axatilimab + CAR-T in High-Risk Lymphoma

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diffuse Large B Cell Lymphoma (DLBCL)Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma High-grade B-cell Lymphoma (HGBCL)High-Grade B-Cell Lymphoma, Nos PMBCL Follicular Grade 3 Lymphoma

Interventions

AxatilimabDRUG

Dose Level -1: 0.1mg/kg Dose Level +1: 0.3mg/kg Dose Level +2: 1mg/kg Dose Level +3: 3mg/kg

Eligibility

Sex: ALLMin age: 8 Years

Medical Language ↔ Plain English

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

Locations (1)

Northside Hospital

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

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

Time frame: 1 year

Estimate 1 year progression-free survival

Estimate 1 year progression-free survival by assessing disease status at 1 year following CAR T infusion

Time frame: 1 year

Secondary Outcomes

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

Time frame: 1 year

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

Time frame: 1 year

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

Time frame: 1 year

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

Time frame: 1 year

Characterize the safety of axatilimab in combination with CAR T therapy

Central Contacts

Joseph Maakaron, MD

CONTACT

404-255-1930 jmaakaron@bmtga.com

Caitlin Guzowski, MBA, MHA, CCRC

CONTACT

404-851-8523 caitlin.guzowski@northside.com

Data from ClinicalTrials.gov

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