Axatilimab + CAR-T for High-Risk Lymphoma

NCT07638982 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: NSH 1445
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

Axatilimab + CAR-T in High-Risk Lymphoma

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

  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

  1 year

Secondary Outcomes (5)

• Estimate overall response rate

  1 year

• Estimate the overall survival of patients

  1 year

• Evaluate duration of response

  1 year

• Characterize the safety of axatilimab in combination with CAR T therapy

  1 year

• Characterize the safety of axatilimab in combination with CAR T therapy

  1 year

Study Arms (1)

Axatilimab + Commercial CAR T cell therapy

EXPERIMENTAL

Drug: Axatilimab

Interventions

Axatilimab DRUG

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

Axatilimab + Commercial CAR T cell therapy

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northside Hospital, Inc.: lead

Study Sites (1)

Northside Hospital

Atlanta, Georgia, 30342, United States

Location

Related Publications (22)

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• Iacoboni G, Navarro V, Martin-Lopez AA, Rejeski K, Kwon M, Jalowiec KA, Amat P, Reguera-Ortega JL, Gallur L, Blumenberg V, Gutierrez-Herrero S, Roddie C, Benzaquen A, Delgado-Serrano J, Sanchez-Salinas MA, Bailen R, Carpio C, Lopez-Corral L, Hernani R, Bastos M, O'Reilly M, Martin-Martin L, Subklewe M, Barba P. Recent Bendamustine Treatment Before Apheresis Has a Negative Impact on Outcomes in Patients With Large B-Cell Lymphoma Receiving Chimeric Antigen Receptor T-Cell Therapy. J Clin Oncol. 2024 Jan 10;42(2):205-217. doi: 10.1200/JCO.23.01097. Epub 2023 Oct 24.

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• Vercellino L, Di Blasi R, Kanoun S, Tessoulin B, Rossi C, D'Aveni-Piney M, Oberic L, Bodet-Milin C, Bories P, Olivier P, Lafon I, Berriolo-Riedinger A, Galli E, Bernard S, Rubio MT, Bossard C, Meignin V, Merlet P, Feugier P, Le Gouill S, Ysebaert L, Casasnovas O, Meignan M, Chevret S, Thieblemont C. Predictive factors of early progression after CAR T-cell therapy in relapsed/refractory diffuse large B-cell lymphoma. Blood Adv. 2020 Nov 24;4(22):5607-5615. doi: 10.1182/bloodadvances.2020003001.

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MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Pyloric Stenosis, Hypertrophic; Lymphoma, Follicular

Interventions

axatilimab

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Pyloric Stenosis; Gastric Outlet Obstruction; Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Joseph Maakaron, MD

CONTACT

404-255-1930; jmaakaron@bmtga.com

Caitlin Guzowski, MBA, MHA, CCRC

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 10, 2026
• Study Start (Estimated): October 31, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)