CK0802 for Treatment of Steroid Refractory Graft vs. Host Disease (GVHD)
7 maggio 2026 aggiornato da: Cellenkos, Inc.
The purpose of this study is to determine the efficacy and safety of CK0802 Tregs for treatment of refractory GVHD (graft-versus-host disease)
Panoramica dello studio
Stato
Non ancora reclutamento
Descrizione dettagliata
This clinical trial will be conducted in two parts where the first part of Phase 1b will determine the safety and tolerability of CK0802 in patients with steroid refractory GVHD and the second part of Phase 2a will examine the preliminary efficacy of CK0802 in patients with steroid refractory GVHD
Tipo di studio
Interventistico
Iscrizione (Stimato)
12
Fase
- Fase 2
- Fase 1
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Clinical Trial Specialist
- Numero di telefono: 8002178247
- Email: contact@cellenkosinc.com
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
Inclusion Criteria:
- 1. Age ≥12 years old (first 3 subjects will be ≥ 18 years)
- 2. Grade 2-4 acute GVHD (aGVHD) at baseline
- 3. No other prior aGVHD treatment
- 4. Steroid Refractory
- Progressed after 3 days of treatment with 2 mg/kg methylprednisolone (MPE)
- No improvement after 7 days of treatment with 2 mg/kg MPE
- Progressed to a new organ after treatment with 1 mg/kg MPE for skin or upper gastrointestinal (UGI) aGVHD
- Progressed from nadir during or after a steroid taper
- 5. Female subjects of childbearing potential (FPCP) must have a negative urine or serum pregnancy test.
- 6. Agreed to abide by all protocol required procedures including study-related assessments, visits and long term follow up.
- 7. Willing and able to provide written informed consent.
- 8. Signed informed consent
Exclusion Criteria:
- 1. 30 days prior treatment with any other investigational agent after allogeneic HSCT.
- 2. Known HIV seropositivity.
- 3. Uncontrolled infection, not responding to appropriate antimicrobial agents after seven days of therapy. The Protocol PI is the final arbiter of eligibility.
- 4. Subjects with uncontrolled inter-current illness that in the opinion of the investigator would place the subject at greater risk of severe toxicity and/or impair the activity of CK0802.
- 5. Subjects who are pregnant or breastfeeding.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Treatment Arm
CK0802 Tregs will be administered intravenously at a fixed dose of 100 million Treg cells.
|
Subjects will receive seven planned doses of CK0802 on study day +1, +3 (+/-1 day), +5 (+/-1 day), +7 (+/- 2 day), +14 (+/- 3 days), +21 (+/-3 days) and +28 (+/-3 days). A total of 7 doses will be administered. If Day 29 assessment shows PR or MR, then 4 additional weekly infusion of CK0802 Tregs can be administered (study days: 35 (+/- 2 day), 42 (+/- 2 day), 49 (+/- 2 day), and 55(+/- 2 day)), for a total of 11 infusions |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Phase 1b
Lasso di tempo: Day +29
|
Dose limiting toxicities of CK0802 in SR GVHD as assessed by the incidence and severity of AE and SAEs determined by the NCI-CTCAE Version 6.0. Non-Hematologic: Any ≥ Grade 3 non-hematologic AE as per CTCAE v6.0 Hematologic: Any new or worsened Grade 4 neutropenia, thrombocytopenia, or anemia compared with baseline that persists for >7 days despite supportive care and is not clearly and incontrovertibly attributable to the underlying disease or another extraneous cause. Death: Death within 28 days that is not clearly and incontrovertibly attributable to the underlying disease or another extraneous cause |
Day +29
|
|
Phase 2a
Lasso di tempo: D +29
|
Overall Response (OR) at day +29. Overall response (OR) will include complete response (CR) and partial response (PR). Response to be determined from the maximum acute GVHD stage and grade in each organ. Complete Response (CR): Stage 0 in all organs (skin, liver, and GI tract) and no intervening additional therapy Partial Response (PR): Improvement of at least 1 stage in 1 or more organs without progression in other organs, and no intervening additional therapy Overall Response (OR): Includes both CR and PR Very Good PR (VGPR): Improvement by at least one stage in one or more organs and
|
D +29
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 1989 Mar;10(1):1-10. doi: 10.1016/0197-2456(89)90015-9.
- Brunstein CG, Miller JS, Cao Q, McKenna DH, Hippen KL, Curtsinger J, Defor T, Levine BL, June CH, Rubinstein P, McGlave PB, Blazar BR, Wagner JE. Infusion of ex vivo expanded T regulatory cells in adults transplanted with umbilical cord blood: safety profile and detection kinetics. Blood. 2011 Jan 20;117(3):1061-70. doi: 10.1182/blood-2010-07-293795. Epub 2010 Oct 15.
- Brunstein CG, Miller JS, McKenna DH, Hippen KL, DeFor TE, Sumstad D, Curtsinger J, Verneris MR, MacMillan ML, Levine BL, Riley JL, June CH, Le C, Weisdorf DJ, McGlave PB, Blazar BR, Wagner JE. Umbilical cord blood-derived T regulatory cells to prevent GVHD: kinetics, toxicity profile, and clinical effect. Blood. 2016 Feb 25;127(8):1044-51. doi: 10.1182/blood-2015-06-653667. Epub 2015 Nov 12.
- Gladstone DE, Kim BS, Mooney K, Karaba AH, D'Alessio FR. Regulatory T Cells for Treating Patients With COVID-19 and Acute Respiratory Distress Syndrome: Two Case Reports. Ann Intern Med. 2020 Nov 17;173(10):852-853. doi: 10.7326/L20-0681. Epub 2020 Jul 6. No abstract available.
- Kellner JN, Delemarre EM, Yvon E, Nierkens S, Boelens JJ, McNiece I, Olson A, Nieto Y, Ciurea S, Popat U, Ahmed S, Champlin R, Ramos J, Nishimoto M, Ma H, Ke Z, Thall P, Khoury JD, Negrin R, Andersson B, Parmar S. Third party, umbilical cord blood derived regulatory T-cells for prevention of graft versus host disease in allogeneic hematopoietic stem cell transplantation: feasibility, safety and immune reconstitution. Oncotarget. 2018 Nov 2;9(86):35611-35622. doi: 10.18632/oncotarget.26242. eCollection 2018 Nov 2.
- Sakaguchi S. Regulatory T cells: history and perspective. Methods Mol Biol. 2011;707:3-17. doi: 10.1007/978-1-61737-979-6_1.
- Taylor PA, Lees CJ, Blazar BR. The infusion of ex vivo activated and expanded CD4(+)CD25(+) immune regulatory cells inhibits graft-versus-host disease lethality. Blood. 2002 May 15;99(10):3493-9. doi: 10.1182/blood.v99.10.3493.
- Edinger M, Hoffmann P, Ermann J, Drago K, Fathman CG, Strober S, Negrin RS. CD4+CD25+ regulatory T cells preserve graft-versus-tumor activity while inhibiting graft-versus-host disease after bone marrow transplantation. Nat Med. 2003 Sep;9(9):1144-50. doi: 10.1038/nm915. Epub 2003 Aug 17.
- Zorn E, Kim HT, Lee SJ, Floyd BH, Litsa D, Arumugarajah S, Bellucci R, Alyea EP, Antin JH, Soiffer RJ, Ritz J. Reduced frequency of FOXP3+ CD4+CD25+ regulatory T cells in patients with chronic graft-versus-host disease. Blood. 2005 Oct 15;106(8):2903-11. doi: 10.1182/blood-2005-03-1257. Epub 2005 Jun 21.
- Rieger K, Loddenkemper C, Maul J, Fietz T, Wolff D, Terpe H, Steiner B, Berg E, Miehlke S, Bornhauser M, Schneider T, Zeitz M, Stein H, Thiel E, Duchmann R, Uharek L. Mucosal FOXP3+ regulatory T cells are numerically deficient in acute and chronic GvHD. Blood. 2006 Feb 15;107(4):1717-23. doi: 10.1182/blood-2005-06-2529. Epub 2005 Nov 8.
- Rezvani K, Mielke S, Ahmadzadeh M, Kilical Y, Savani BN, Zeilah J, Keyvanfar K, Montero A, Hensel N, Kurlander R, Barrett AJ. High donor FOXP3-positive regulatory T-cell (Treg) content is associated with a low risk of GVHD following HLA-matched allogeneic SCT. Blood. 2006 Aug 15;108(4):1291-7. doi: 10.1182/blood-2006-02-003996. Epub 2006 Apr 20.
- Jagasia MH, Greinix HT, Arora M, Williams KM, Wolff D, Cowen EW, Palmer J, Weisdorf D, Treister NS, Cheng GS, Kerr H, Stratton P, Duarte RF, McDonald GB, Inamoto Y, Vigorito A, Arai S, Datiles MB, Jacobsohn D, Heller T, Kitko CL, Mitchell SA, Martin PJ, Shulman H, Wu RS, Cutler CS, Vogelsang GB, Lee SJ, Pavletic SZ, Flowers ME. National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: I. The 2014 Diagnosis and Staging Working Group report. Biol Blood Marrow Transplant. 2015 Mar;21(3):389-401.e1. doi: 10.1016/j.bbmt.2014.12.001. Epub 2014 Dec 18.
- Jagasia M, Arora M, Flowers ME, Chao NJ, McCarthy PL, Cutler CS, Urbano-Ispizua A, Pavletic SZ, Haagenson MD, Zhang MJ, Antin JH, Bolwell BJ, Bredeson C, Cahn JY, Cairo M, Gale RP, Gupta V, Lee SJ, Litzow M, Weisdorf DJ, Horowitz MM, Hahn T. Risk factors for acute GVHD and survival after hematopoietic cell transplantation. Blood. 2012 Jan 5;119(1):296-307. doi: 10.1182/blood-2011-06-364265. Epub 2011 Oct 18.
- Miklos D, Cutler CS, Arora M, Waller EK, Jagasia M, Pusic I, Flowers ME, Logan AC, Nakamura R, Blazar BR, Li Y, Chang S, Lal I, Dubovsky J, James DF, Styles L, Jaglowski S. Ibrutinib for chronic graft-versus-host disease after failure of prior therapy. Blood. 2017 Nov 23;130(21):2243-2250. doi: 10.1182/blood-2017-07-793786. Epub 2017 Sep 18.
- Dignan FL, Clark A, Amrolia P, Cornish J, Jackson G, Mahendra P, Scarisbrick JJ, Taylor PC, Hadzic N, Shaw BE, Potter MN; Haemato-oncology Task Force of British Committee for Standards in Haematology; British Society for Blood and Marrow Transplantation. Diagnosis and management of acute graft-versus-host disease. Br J Haematol. 2012 Jul;158(1):30-45. doi: 10.1111/j.1365-2141.2012.09129.x. Epub 2012 Apr 26.
- Dignan FL, Amrolia P, Clark A, Cornish J, Jackson G, Mahendra P, Scarisbrick JJ, Taylor PC, Shaw BE, Potter MN; Haemato-oncology Task Force of British Committee for Standards in Haematology; British Society for Blood and Marrow Transplantation. Diagnosis and management of chronic graft-versus-host disease. Br J Haematol. 2012 Jul;158(1):46-61. doi: 10.1111/j.1365-2141.2012.09128.x. Epub 2012 Apr 26.
- Di Ianni M, Falzetti F, Carotti A, Terenzi A, Castellino F, Bonifacio E, Del Papa B, Zei T, Ostini RI, Cecchini D, Aloisi T, Perruccio K, Ruggeri L, Balucani C, Pierini A, Sportoletti P, Aristei C, Falini B, Reisner Y, Velardi A, Aversa F, Martelli MF. Tregs prevent GVHD and promote immune reconstitution in HLA-haploidentical transplantation. Blood. 2011 Apr 7;117(14):3921-8. doi: 10.1182/blood-2010-10-311894. Epub 2011 Feb 3.
- Martelli MF, Di Ianni M, Ruggeri L, Falzetti F, Carotti A, Terenzi A, Pierini A, Massei MS, Amico L, Urbani E, Del Papa B, Zei T, Iacucci Ostini R, Cecchini D, Tognellini R, Reisner Y, Aversa F, Falini B, Velardi A. HLA-haploidentical transplantation with regulatory and conventional T-cell adoptive immunotherapy prevents acute leukemia relapse. Blood. 2014 Jul 24;124(4):638-44. doi: 10.1182/blood-2014-03-564401. Epub 2014 Jun 12.
- Gratwohl A, Brand R, Frassoni F, Rocha V, Niederwieser D, Reusser P, Einsele H, Cordonnier C; Acute and Chronic Leukemia Working Parties; Infectious Diseases Working Party of the European Group for Blood and Marrow Transplantation. Cause of death after allogeneic haematopoietic stem cell transplantation (HSCT) in early leukaemias: an EBMT analysis of lethal infectious complications and changes over calendar time. Bone Marrow Transplant. 2005 Nov;36(9):757-69. doi: 10.1038/sj.bmt.1705140.
- Ferrara JL, Levine JE, Reddy P, Holler E. Graft-versus-host disease. Lancet. 2009 May 2;373(9674):1550-61. doi: 10.1016/S0140-6736(09)60237-3. Epub 2009 Mar 11.
- Martin PJ, Rizzo JD, Wingard JR, Ballen K, Curtin PT, Cutler C, Litzow MR, Nieto Y, Savani BN, Schriber JR, Shaughnessy PJ, Wall DA, Carpenter PA. First- and second-line systemic treatment of acute graft-versus-host disease: recommendations of the American Society of Blood and Marrow Transplantation. Biol Blood Marrow Transplant. 2012 Aug;18(8):1150-63. doi: 10.1016/j.bbmt.2012.04.005. Epub 2012 Apr 14.
- Arai S, Margolis J, Zahurak M, Anders V, Vogelsang GB. Poor outcome in steroid-refractory graft-versus-host disease with antithymocyte globulin treatment. Biol Blood Marrow Transplant. 2002;8(3):155-60. doi: 10.1053/bbmt.2002.v8.pm11939605.
- Riley JL, June CH, Blazar BR. Human T regulatory cell therapy: take a billion or so and call me in the morning. Immunity. 2009 May;30(5):656-65. doi: 10.1016/j.immuni.2009.04.006.
- Sakaguchi S, Miyara M, Costantino CM, Hafler DA. FOXP3+ regulatory T cells in the human immune system. Nat Rev Immunol. 2010 Jul;10(7):490-500. doi: 10.1038/nri2785. Epub 2010 Jun 18.
- Wang Y, Perlman S. COVID-19: Inflammatory Profile. Annu Rev Med. 2022 Jan 27;73:65-80. doi: 10.1146/annurev-med-042220-012417. Epub 2021 Aug 26.
- Meyer EH, Laport G, Xie BJ, MacDonald K, Heydari K, Sahaf B, Tang SW, Baker J, Armstrong R, Tate K, Tadisco C, Arai S, Johnston L, Lowsky R, Muffly L, Rezvani AR, Shizuru J, Weng WK, Sheehan K, Miklos D, Negrin RS. Transplantation of donor grafts with defined ratio of conventional and regulatory T cells in HLA-matched recipients. JCI Insight. 2019 May 16;4(10):e127244. doi: 10.1172/jci.insight.127244. eCollection 2019 May 16.
- Kebriaei P, Hayes J, Daly A, Uberti J, Marks DI, Soiffer R, Waller EK, Burke E, Skerrett D, Shpall E, Martin PJ. A Phase 3 Randomized Study of Remestemcel-L versus Placebo Added to Second-Line Therapy in Patients with Steroid-Refractory Acute Graft-versus-Host Disease. Biol Blood Marrow Transplant. 2020 May;26(5):835-844. doi: 10.1016/j.bbmt.2019.08.029. Epub 2019 Sep 7.
- WALLACE AB. The exposure treatment of burns. Lancet. 1951 Mar 3;1(6653):501-4. doi: 10.1016/s0140-6736(51)91975-7. No abstract available.
- Levine JE. Prediction and Prognostication of Acute Graft-Versus-Host Disease by MAGIC Biomarkers. Am J Hematol. 2025 May;100 Suppl 3(Suppl 3):5-13. doi: 10.1002/ajh.27594.
- Malard F, Huang XJ, Sim JPY. Treatment and unmet needs in steroid-refractory acute graft-versus-host disease. Leukemia. 2020 May;34(5):1229-1240. doi: 10.1038/s41375-020-0804-2. Epub 2020 Apr 3.
- Mahat U, Przepiorka D, Fashoyin-Aje LA. Remestemcel-L-rknd for Steroid-Refractory Acute Graft-vs-Host Disease in Pediatric Patients. JAMA. 2025 Jul 1;334(1):81-82. doi: 10.1001/jama.2025.6179.
- Shneider NA, Nesta AV, Rifai OM, Yasek J, Elyaman W, Aziz-Zaman S, Lyu MA, Levy SHS, Hoover BN, Vlad G, Huang M, Zeng K, Sadeghi T, Reddy A, Flowers CR, Parmar S. Clinical Safety and Preliminary Efficacy of Regulatory T Cells for ALS. NEJM Evid. 2025 May;4(5):EVIDoa2400249. doi: 10.1056/EVIDoa2400249. Epub 2025 Apr 22.
- Kadia TM, Huang M, Pemmaraju N, Abbas HA, Ly C, Masarova L, Yilmaz M, Lyu MA, Zeng K, Sadeghi T, Cook R, DiNardo CD, Daver N, Issa GC, Jabbour E, Borthakur G, Jain N, Garcia-Manero G, Parmar S, Flowers C, Kantarjian H, Verstovsek S. Phase 1 Study of CK0801 in Treatment of Bone Marrow Failure Syndromes. NEJM Evid. 2024 Jun;3(6):EVIDoa2300362. doi: 10.1056/EVIDoa2300362. Epub 2024 May 28.
- Gladstone DE, D'Alessio F, Howard C, Lyu MA, Mock JR, Gibbs KW, Abrams D, Huang M, Zeng K, Herlihy JP, Castillo ST, Bassett R, Sadeghi T, Parmar S, Flowers CR, Mukherjee S, Schoenfeld D, Thall PF, Slutsky AS. Randomized, double-blinded, placebo-controlled trial of allogeneic cord blood T-regulatory cells for treatment of COVID-19 ARDS. Blood Adv. 2023 Jul 11;7(13):3075-3079. doi: 10.1182/bloodadvances.2022009619. No abstract available.
- Fajgenbaum DC, June CH. Cytokine Storm. N Engl J Med. 2020 Dec 3;383(23):2255-2273. doi: 10.1056/NEJMra2026131. No abstract available.
- Chen R, Lan Z, Ye J, Pang L, Liu Y, Wu W, Qin X, Guo Y, Zhang P. Cytokine Storm: The Primary Determinant for the Pathophysiological Evolution of COVID-19 Deterioration. Front Immunol. 2021 Apr 28;12:589095. doi: 10.3389/fimmu.2021.589095. eCollection 2021.
- Matsuoka K, Kim HT, McDonough S, Bascug G, Warshauer B, Koreth J, Cutler C, Ho VT, Alyea EP, Antin JH, Soiffer RJ, Ritz J. Altered regulatory T cell homeostasis in patients with CD4+ lymphopenia following allogeneic hematopoietic stem cell transplantation. J Clin Invest. 2010 May;120(5):1479-93. doi: 10.1172/JCI41072. Epub 2010 Apr 12.
- Koenecke C, Czeloth N, Bubke A, Schmitz S, Kissenpfennig A, Malissen B, Huehn J, Ganser A, Forster R, Prinz I. Alloantigen-specific de novo-induced Foxp3+ Treg revert in vivo and do not protect from experimental GVHD. Eur J Immunol. 2009 Nov;39(11):3091-6. doi: 10.1002/eji.200939432.
- Mutis T, van Rijn RS, Simonetti ER, Aarts-Riemens T, Emmelot ME, van Bloois L, Martens A, Verdonck LF, Ebeling SB. Human regulatory T cells control xenogeneic graft-versus-host disease induced by autologous T cells in RAG2-/-gammac-/- immunodeficient mice. Clin Cancer Res. 2006 Sep 15;12(18):5520-5. doi: 10.1158/1078-0432.CCR-06-0035.
- Cao T, Soto A, Zhou W, Wang W, Eck S, Walker M, Harriman G, Li L. Ex vivo expanded human CD4+CD25+Foxp3+ regulatory T cells prevent lethal xenogenic graft versus host disease (GVHD). Cell Immunol. 2009;258(1):65-71. doi: 10.1016/j.cellimm.2009.03.013. Epub 2009 May 1.
- Hoffmann P, Ermann J, Edinger M, Fathman CG, Strober S. Donor-type CD4(+)CD25(+) regulatory T cells suppress lethal acute graft-versus-host disease after allogeneic bone marrow transplantation. J Exp Med. 2002 Aug 5;196(3):389-99. doi: 10.1084/jem.20020399.
- Di Ianni M, Olioso P, Giancola R, Santarone S, Natale A, Papalinetti G, Villanova I, Baldoni S, Di Tommaso A, Bonfini T, Accorsi P, Di Bartolomeo P. Treg-protected donor lymphocyte infusions: a new tool to address the graft-versus-leukemia effect in the absence of graft-versus-host disease in patients relapsed after HSCT. Int J Hematol. 2017 Dec;106(6):860-864. doi: 10.1007/s12185-017-2292-3. Epub 2017 Jul 18.
- Ohkura N, Kitagawa Y, Sakaguchi S. Development and maintenance of regulatory T cells. Immunity. 2013 Mar 21;38(3):414-23. doi: 10.1016/j.immuni.2013.03.002.
- Tang Q, Bluestone JA. Regulatory T-cell therapy in transplantation: moving to the clinic. Cold Spring Harb Perspect Med. 2013 Nov 1;3(11):a015552. doi: 10.1101/cshperspect.a015552.
- Schneidawind D, Pierini A, Negrin RS. Regulatory T cells and natural killer T cells for modulation of GVHD following allogeneic hematopoietic cell transplantation. Blood. 2013 Oct 31;122(18):3116-21. doi: 10.1182/blood-2013-08-453126. Epub 2013 Sep 25.
- Burrell BE, Nakayama Y, Xu J, Brinkman CC, Bromberg JS. Regulatory T cell induction, migration, and function in transplantation. J Immunol. 2012 Nov 15;189(10):4705-11. doi: 10.4049/jimmunol.1202027.
- Martin PJ. How I treat steroid-refractory acute graft-versus-host disease. Blood. 2020 May 7;135(19):1630-1638. doi: 10.1182/blood.2019000960.
- Xu Z, Wang H. Targeting the chemokines in acute graft-versus-host disease. Front Immunol. 2025 Jan 7;15:1525244. doi: 10.3389/fimmu.2024.1525244. eCollection 2024.
- Mehta RS, Saliba RM, Jan A, Shigle TL, Wang E, Nieto Y, Ciurea SO, Oran B, Im J, Olson A, Marin D, Qazilbash M, Khouri I, Rondon G, Anderlini P, Rezvani K, Popat U, Kebriaei P, Shpall E, Champlin R, Alousi A. Vedolizumab for Steroid Refractory Lower Gastrointestinal Tract Graft-Versus-Host Disease. Transplant Cell Ther. 2021 Mar;27(3):272.e1-272.e5. doi: 10.1016/j.jtct.2020.12.011. Epub 2020 Dec 16.
- Bukauskas A, Griskevicius L, Peceliunas V. Lessons Learned from Early Experiences with Vedolizumab for Steroid-Refractory Acute Graft- versus-Host Disease with Gastrointestinal Involvement. Biol Blood Marrow Transplant. 2017 Sep;23(9):1597. doi: 10.1016/j.bbmt.2017.05.028. Epub 2017 May 31. No abstract available.
- Floisand Y, Lundin KEA, Lazarevic V, Kristiansen JD, Osnes LTN, Tjonnfjord GE, Reims HM, Gedde-Dahl T. Targeting Integrin alpha4beta7 in Steroid-Refractory Intestinal Graft-versus-Host Disease. Biol Blood Marrow Transplant. 2017 Jan;23(1):172-175. doi: 10.1016/j.bbmt.2016.10.009. Epub 2016 Oct 21.
- Wyant T, Fedyk E, Abhyankar B. An Overview of the Mechanism of Action of the Monoclonal Antibody Vedolizumab. J Crohns Colitis. 2016 Dec;10(12):1437-1444. doi: 10.1093/ecco-jcc/jjw092. Epub 2016 Jun 1.
- Kurtzberg J, Abdel-Azim H, Carpenter P, Chaudhury S, Horn B, Mahadeo K, Nemecek E, Neudorf S, Prasad V, Prockop S, Quigg T, Satwani P, Cheng A, Burke E, Hayes J, Skerrett D; MSB-GVHD001/002 Study Group. A Phase 3, Single-Arm, Prospective Study of Remestemcel-L, Ex Vivo Culture-Expanded Adult Human Mesenchymal Stromal Cells for the Treatment of Pediatric Patients Who Failed to Respond to Steroid Treatment for Acute Graft-versus-Host Disease. Biol Blood Marrow Transplant. 2020 May;26(5):845-854. doi: 10.1016/j.bbmt.2020.01.018. Epub 2020 Feb 1.
- Garnett C, Apperley JF, Pavlu J. Treatment and management of graft-versus-host disease: improving response and survival. Ther Adv Hematol. 2013 Dec;4(6):366-78. doi: 10.1177/2040620713489842.
- Magenau J, Runaas L, Reddy P. Advances in understanding the pathogenesis of graft-versus-host disease. Br J Haematol. 2016 Apr;173(2):190-205. doi: 10.1111/bjh.13959. Epub 2016 Mar 27.
- Ruutu T, Gratwohl A, de Witte T, Afanasyev B, Apperley J, Bacigalupo A, Dazzi F, Dreger P, Duarte R, Finke J, Garderet L, Greinix H, Holler E, Kroger N, Lawitschka A, Mohty M, Nagler A, Passweg J, Ringden O, Socie G, Sierra J, Sureda A, Wiktor-Jedrzejczak W, Madrigal A, Niederwieser D. Prophylaxis and treatment of GVHD: EBMT-ELN working group recommendations for a standardized practice. Bone Marrow Transplant. 2014 Feb;49(2):168-73. doi: 10.1038/bmt.2013.107. Epub 2013 Jul 29.
- Loiseau P, Busson M, Balere ML, Dormoy A, Bignon JD, Gagne K, Gebuhrer L, Dubois V, Jollet I, Bois M, Perrier P, Masson D, Moine A, Absi L, Reviron D, Lepage V, Tamouza R, Toubert A, Marry E, Chir Z, Jouet JP, Blaise D, Charron D, Raffoux C. HLA Association with hematopoietic stem cell transplantation outcome: the number of mismatches at HLA-A, -B, -C, -DRB1, or -DQB1 is strongly associated with overall survival. Biol Blood Marrow Transplant. 2007 Aug;13(8):965-74. doi: 10.1016/j.bbmt.2007.04.010.
- Reddy P. Pathophysiology of acute graft-versus-host disease. Hematol Oncol. 2003 Dec;21(4):149-61. doi: 10.1002/hon.716.
- Flowers ME, Inamoto Y, Carpenter PA, Lee SJ, Kiem HP, Petersdorf EW, Pereira SE, Nash RA, Mielcarek M, Fero ML, Warren EH, Sanders JE, Storb RF, Appelbaum FR, Storer BE, Martin PJ. Comparative analysis of risk factors for acute graft-versus-host disease and for chronic graft-versus-host disease according to National Institutes of Health consensus criteria. Blood. 2011 Mar 17;117(11):3214-9. doi: 10.1182/blood-2010-08-302109. Epub 2011 Jan 24.
- Lazaryan A, Weisdorf DJ, DeFor T, Brunstein CG, MacMillan ML, Bejanyan N, Holtan S, Blazar BR, Wagner JE, Arora M. Risk Factors for Acute and Chronic Graft-versus-Host Disease after Allogeneic Hematopoietic Cell Transplantation with Umbilical Cord Blood and Matched Sibling Donors. Biol Blood Marrow Transplant. 2016 Jan;22(1):134-40. doi: 10.1016/j.bbmt.2015.09.008. Epub 2015 Sep 11.
- Sarantopoulos S, Stevenson KE, Kim HT, Bhuiya NS, Cutler CS, Soiffer RJ, Antin JH, Ritz J. High levels of B-cell activating factor in patients with active chronic graft-versus-host disease. Clin Cancer Res. 2007 Oct 15;13(20):6107-14. doi: 10.1158/1078-0432.CCR-07-1290.
- Alexander KA, Flynn R, Lineburg KE, Kuns RD, Teal BE, Olver SD, Lor M, Raffelt NC, Koyama M, Leveque L, Le Texier L, Melino M, Markey KA, Varelias A, Engwerda C, Serody JS, Janela B, Ginhoux F, Clouston AD, Blazar BR, Hill GR, MacDonald KP. CSF-1-dependant donor-derived macrophages mediate chronic graft-versus-host disease. J Clin Invest. 2014 Oct;124(10):4266-80. doi: 10.1172/JCI75935. Epub 2014 Aug 26.
- Malard F, Holler E, Sandmaier BM, Huang H, Mohty M. Acute graft-versus-host disease. Nat Rev Dis Primers. 2023 Jun 8;9(1):27. doi: 10.1038/s41572-023-00438-1.
- Ma HH, Ziegler J, Li C, Sepulveda A, Bedeir A, Grandis J, Lentzsch S, Mapara MY. Sequential activation of inflammatory signaling pathways during graft-versus-host disease (GVHD): early role for STAT1 and STAT3. Cell Immunol. 2011;268(1):37-46. doi: 10.1016/j.cellimm.2011.01.008. Epub 2011 Feb 4.
- Choi J, Ziga ED, Ritchey J, Collins L, Prior JL, Cooper ML, Piwnica-Worms D, DiPersio JF. IFNgammaR signaling mediates alloreactive T-cell trafficking and GVHD. Blood. 2012 Nov 8;120(19):4093-103. doi: 10.1182/blood-2012-01-403196. Epub 2012 Sep 12.
- Kolb HJ. Hematopoietic stem cell transplantation and cellular therapy. HLA. 2017 May;89(5):267-277. doi: 10.1111/tan.13005.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 luglio 2026
Completamento primario (Stimato)
30 giugno 2028
Completamento dello studio (Stimato)
30 giugno 2029
Date di iscrizione allo studio
Primo inviato
1 maggio 2026
Primo inviato che soddisfa i criteri di controllo qualità
1 maggio 2026
Primo Inserito (Effettivo)
8 maggio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
11 maggio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
7 maggio 2026
Ultimo verificato
1 maggio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie del sistema immunitario
- Malattia del trapianto contro l'ospite
- Tecniche investigative
- Terapie
- Tecniche di laboratorio clinico
- Tecniche e procedure diagnostiche
- Diagnosi
- Tecniche citologiche
- Tecniche istologiche
- Conservazione dei tessuti
- Conservazione, biologica
- Tecniche di preparazione istocitologica
- Crioconservazione
Altri numeri di identificazione dello studio
- CK0802-101-1
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
IPD can be shared based on request and after proper de-identifiers to protect individual patient information is in place.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Sì
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .