Clinical trial · Interventional
Axatilimab + CAR-T for High-Risk Lymphoma
An Open-label, Phase I Trial, With an Expansion Cohort: Macrophage Conditioning to Synergize With CAR-T in High-risk Lymphoma (MAC-SHIFT)
NCT07638982CI-TRIAL-00114171not yet recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Axatilimab + CAR-T in High-Risk Lymphoma
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B Cell Lymphoma (DLBCL) | Diffuse Large B-Cell Lymphoma | ALIAS | 0.90 |
| Follicular Grade 3 Lymphoma | — | UNRESOLVED | — |
| High-grade B-cell Lymphoma (HGBCL) | High Grade B-Cell Lymphoma | CURATED_BROADER | 0.80 |
| High-Grade B-Cell Lymphoma, Nos | High Grade B-Cell Lymphoma | CURATED_BROADER | 0.80 |
| PMBCL | — | UNRESOLVED | — |
| Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma | Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Axatilimab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Axatilimab + Commercial CAR T cell therapy
- interventionNames
- Drug: Axatilimab
Primary outcomes (2)
- measure
- Determine the recommended Phase 2 dose (RP2D) of axatilimab
- timeFrame
- 1 year
- description
- 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
- measure
- Estimate 1 year progression-free survival
- timeFrame
- 1 year
- description
- Estimate 1 year progression-free survival by assessing disease status at 1 year following CAR T infusion
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 8 Years
Show eligibility criteria text
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
References
Publications (22)
- BACKGROUNDHaranaka 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. PMID 40381116
- BACKGROUNDKitko 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. PMID 36459673
- BACKGROUNDYan 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. PMID 31444250
- BACKGROUNDCarniti 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. PMID 38359407
- BACKGROUNDJain 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.