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NCT Number: NCT07638982

Axatilimab + CAR-T for High-Risk Lymphoma

Axatilimab + CAR-T in High-Risk Lymphoma

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Key information

Conditions

Diffuse Large B Cell Lymphoma (DLBCL) Digestive System Diseases Follicular Grade 3 Lymphoma Gastric Outlet Obstruction Gastrointestinal Diseases Hemic and Lymphatic Diseases High-Grade B-Cell Lymphoma, Nos High-grade B-cell Lymphoma (HGBCL) Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type PMBCL Pyloric Stenosis Pyloric Stenosis, Hypertrophic Stomach Diseases Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma

Age range

8 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Axatilimab

Drug

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

Primary outcomes

  1. Determine the recommended Phase 2 dose (RP2D) of axatilimab

    Time frame: 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

  2. Estimate 1 year progression-free survival

    Time frame: 1 year

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

Secondary outcomes

  1. Estimate overall response rate

    Time frame: 1 year

    Estimate overall response rate (a combination of complete and partial responders) by assessing disease status at 1 year following CAR T infusion

  2. Estimate the overall survival of patients

    Time frame: 1 year

    Estimate the overall survival of patients by following survival status and cause of death for 1 year after CAR T infusion

  3. Evaluate duration of response

    Time frame: 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

  4. Characterize the safety of axatilimab in combination with CAR T therapy

    Time frame: 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

  5. Characterize the safety of axatilimab in combination with CAR T therapy

    Time frame: 1 year

    Characterize the safety of axatilimab in combination with CAR T therapy by assessing the incidence of grade 3 and 4 adverse events using the CTCAE version 6 criteria

Study contacts

Contact information is provided by the study sponsor or research team.

Caitlin Guzowski, MBA, MHA, CCRC

CONTACT

[email protected]

404-851-8523

Joseph Maakaron, MD

CONTACT

[email protected]

404-255-1930

Sponsors and collaborators

Lead sponsor

Northside Hospital, Inc.

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jun 10, 2026
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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