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Diffuse Large B Cell Lymphoma (DLBCL)Phase 1NCT07638982

Axatilimab + CAR-T for High-Risk Lymphoma

A Phase 1 study testing Axatilimab in people with Diffuse Large B Cell Lymphoma (DLBCL) and Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma, run by Northside Hospital, Inc. at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Axatilimab + CAR-T in High-Risk Lymphoma Read more about this study

Who is it for?
Ages 8 years and older
What is being tested?
Axatilimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
1 siteUnited States
Study dates
31 Dec 2026to 31 Dec 2029
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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:
Show all 11Show fewer
  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • Allogeneic transplant within 100 days of enrollment
  • Active acute or chronic graft versus host disease
  • History of acute or chronic pancreatitis
  • History of myositis

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Joseph Maakaron, MD contact

404-255-1930

jmaakaron@bmtga.com

Caitlin Guzowski, MBA, MHA, CCRC contact

404-851-8523

caitlin.guzowski@northside.com

United States1 site

  • Northside Hospital

    Atlanta, Georgia, 30342

    Caitlin Guzowski, MBA, MHA, CCRC, 404-851-8523, caitlin.guzowski@northside.com

Other trials in United States

About this study

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

Axatilimab + CAR-T in High-Risk Lymphoma

Being tested
Axatilimab
Medical subject headings
Lymphoma, Large B-Cell, Diffuse, Pyloric Stenosis, Hypertrophic, Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AxatilimabDrug

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

Study groups in NCT07638982
Study groupRoleWhat they receive
Axatilimab + Commercial CAR T cell therapyExperimentalNot described
Receives: Drug: Axatilimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 1 year

  2. Estimate 1 year progression-free survival

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

    Measured: 1 year

Secondary outcomes (5)

  1. 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

    Measured: 1 year

  2. 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

    Measured: 1 year

  3. 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

    Measured: 1 year

  4. 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

    Measured: 1 year

  5. 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 grade 3 and 4 adverse events using the CTCAE version 6 criteria

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2026
  2. Study start31 Dec 2026 (estimated)
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07638982
Sponsor's protocol ID
NSH 1445
Status last verified
Oct 2026
First submitted
5 Jun 2026
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Haranaka M, Kinami K, Yang YO, Li H, Pratta M, Suzukawa K. Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Axatilimab in Healthy Japanese Male Participants: Results from a Phase 1, Randomized, Double-Blind, Dose-Escalation Study. Clin Drug Investig. 2025 Jun;45(6):327-334. doi: 10.1007/s40261-025-01438-7. Epub 2025 May 17.

    PubMed 40381116

  • Kitko CL, Arora M, DeFilipp Z, Zaid MA, Di Stasi A, Radojcic V, Betts CB, Coussens LM, Meyers ML, Qamoos H, Ordentlich P, Kumar V, Quaranto C, Schmitt A, Gu Y, Blazar BR, Wang TP, Salhotra A, Pusic I, Jagasia M, Lee SJ. Axatilimab for Chronic Graft-Versus-Host Disease After Failure of at Least Two Prior Systemic Therapies: Results of a Phase I/II Study. J Clin Oncol. 2023 Apr 1;41(10):1864-1875. doi: 10.1200/JCO.22.00958. Epub 2022 Dec 2.

    PubMed 36459673

  • Yan ZX, Li L, Wang W, OuYang BS, Cheng S, Wang L, Wu W, Xu PP, Muftuoglu M, Hao M, Yang S, Zhang MC, Zheng Z, Li J, Zhao WL. Clinical Efficacy and Tumor Microenvironment Influence in a Dose-Escalation Study of Anti-CD19 Chimeric Antigen Receptor T Cells in Refractory B-Cell Non-Hodgkin's Lymphoma. Clin Cancer Res. 2019 Dec 1;25(23):6995-7003. doi: 10.1158/1078-0432.CCR-19-0101. Epub 2019 Aug 23.

    PubMed 31444250

  • Carniti C, Caldarelli NM, Agnelli L, Torelli T, Ljevar S, Jonnalagadda S, Zanirato G, Fardella E, Stella F, Lorenzini D, Brich S, Arienti F, Dodero A, Chiappella A, Magni M, Corradini P. Monocytes in leukapheresis products affect the outcome of CD19-targeted CAR T-cell therapy in patients with lymphoma. Blood Adv. 2024 Apr 23;8(8):1968-1980. doi: 10.1182/bloodadvances.2024012563.

    PubMed 38359407

  • Jain MD, Zhao H, Wang X, Atkins R, Menges M, Reid K, Spitler K, Faramand R, Bachmeier C, Dean EA, Cao B, Chavez JC, Shah B, Lazaryan A, Nishihori T, Hussaini M, Gonzalez RJ, Mullinax JE, Rodriguez PC, Conejo-Garcia JR, Anasetti C, Davila ML, Locke FL. Tumor interferon signaling and suppressive myeloid cells are associated with CAR T-cell failure in large B-cell lymphoma. Blood. 2021 May 13;137(19):2621-2633. doi: 10.1182/blood.2020007445.

    PubMed 33512407

  • Wang J, Gao K, Lei W, Dong L, Xuan Q, Feng M, Wang J, Ye X, Jin T, Zhang Z, Zhang Q. Lymphocyte-to-monocyte ratio is associated with prognosis of diffuse large B-cell lymphoma: correlation with CD163 positive M2 type tumor-associated macrophages, not PD-1 positive tumor-infiltrating lymphocytes. Oncotarget. 2017 Jan 17;8(3):5414-5425. doi: 10.18632/oncotarget.14289.

    PubMed 28036275

  • Marchesi F, Cirillo M, Bianchi A, Gately M, Olimpieri OM, Cerchiara E, Renzi D, Micera A, Balzamino BO, Bonini S, Onetti Muda A, Avvisati G. High density of CD68+/CD163+ tumour-associated macrophages (M2-TAM) at diagnosis is significantly correlated to unfavorable prognostic factors and to poor clinical outcomes in patients with diffuse large B-cell lymphoma. Hematol Oncol. 2015 Jun;33(2):110-2. doi: 10.1002/hon.2142. Epub 2014 Apr 8. No abstract available.

    PubMed 24711044

  • Li YL, Shi ZH, Wang X, Gu KS, Zhai ZM. Tumor-associated macrophages predict prognosis in diffuse large B-cell lymphoma and correlation with peripheral absolute monocyte count. BMC Cancer. 2019 Nov 6;19(1):1049. doi: 10.1186/s12885-019-6208-x.

    PubMed 31694577

  • Cencini E, Fabbri A, Schiattone L, Sicuranza A, Mecacci B, Granai M, Mancini V, Lazzi S, Bocchia M, Leoncini L. Prognostic impact of tumor-associated macrophages, lymphocyte-to-monocyte and neutrophil-to-lymphocyte ratio in diffuse large B-cell lymphoma. Am J Blood Res. 2020 Aug 25;10(4):97-108. eCollection 2020.

    PubMed 32923089

  • Wang Z, Jiang R, Li Q, Wang H, Tao Q, Zhai Z. Elevated M-MDSCs in Circulation Are Indicative of Poor Prognosis in Diffuse Large B-Cell Lymphoma Patients. J Clin Med. 2021 Apr 19;10(8):1768. doi: 10.3390/jcm10081768.

    PubMed 33921711

  • Shen L, Li H, Shi Y, Wang D, Gong J, Xun J, Zhou S, Xiang R, Tan X. M2 tumour-associated macrophages contribute to tumour progression via legumain remodelling the extracellular matrix in diffuse large B cell lymphoma. Sci Rep. 2016 Jul 28;6:30347. doi: 10.1038/srep30347.

    PubMed 27464733

  • Benner B, Scarberry L, Suarez-Kelly LP, Duggan MC, Campbell AR, Smith E, Lapurga G, Jiang K, Butchar JP, Tridandapani S, Howard JH, Baiocchi RA, Mace TA, Carson WE 3rd. Generation of monocyte-derived tumor-associated macrophages using tumor-conditioned media provides a novel method to study tumor-associated macrophages in vitro. J Immunother Cancer. 2019 May 28;7(1):140. doi: 10.1186/s40425-019-0622-0.

    PubMed 31138333

  • Ugel S, De Sanctis F, Mandruzzato S, Bronte V. Tumor-induced myeloid deviation: when myeloid-derived suppressor cells meet tumor-associated macrophages. J Clin Invest. 2015 Sep;125(9):3365-76. doi: 10.1172/JCI80006. Epub 2015 Sep 1.

    PubMed 26325033

  • Noy R, Pollard JW. Tumor-associated macrophages: from mechanisms to therapy. Immunity. 2014 Jul 17;41(1):49-61. doi: 10.1016/j.immuni.2014.06.010.

    PubMed 25035953

  • Mantovani A, Allavena P, Sica A, Balkwill F. Cancer-related inflammation. Nature. 2008 Jul 24;454(7203):436-44. doi: 10.1038/nature07205.

    PubMed 18650914

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Axatilimab in people with Diffuse Large B Cell Lymphoma (DLBCL) and Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma, run by Northside Hospital, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Joseph Maakaron, MD (404-255-1930, jmaakaron@bmtga.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine the recommended Phase 2 dose (RP2D) of axatilimab (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07638982, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.

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