drugset / Trial / NCT06499025
Treatment of Relapsed or Refractory t(8; 21) AML With Targeted AML1-ETO Neoantigen Cytotoxic T Cells (CTL)
Phase 0
Enrolling by invitation
16 enrolled
BGI, China
Shenzhen University General Hospital · collab
NaSingle-groupOpen-labelTreatment
Summary
1. To evaluate the safety and tolerability of targeted AML1-ETO neoantigen cytotoxic T cells (CTL) in the treatment of relapsed or refractory acute myeloid leukemia . 2. To evaluate the effectiveness of targeted AML1-ETO neoantigen cytotoxic T cells (CTL),by the complete response rate(CRR) and overall survival (OS) followed.
Timeline
- Start
- 2024-02-01
- Primary completion
- 2026-12-30
- Completion
- 2027-12-30
Publications
- Background Godugu K, Rajabi M, Mousa SA. RETRACTED: Godugu et al. Anti-Cancer Activities of Thyrointegrin alphavbeta3 Antagonist Mono- and Bis-Triazole Tetraiodothyroacetic Acid Conjugated via Polyethylene Glycols in Glioblastoma. Cancers 2021, 13, 2780. Cancers (Basel). 2024 May 15;16(10):1880. doi: 10.3390/cancers16101880.
- Background Falini B, Mecucci C, Tiacci E, Alcalay M, Rosati R, Pasqualucci L, La Starza R, Diverio D, Colombo E, Santucci A, Bigerna B, Pacini R, Pucciarini A, Liso A, Vignetti M, Fazi P, Meani N, Pettirossi V, Saglio G, Mandelli F, Lo-Coco F, Pelicci PG, Martelli MF; GIMEMA Acute Leukemia Working Party. Cytoplasmic nucleophosmin in acute myelogenous leukemia with a normal karyotype. N Engl J Med. 2005 Jan 20;352(3):254-66. doi: 10.1056/NEJMoa041974.
- Background Biernacki MA, Foster KA, Woodward KB, Coon ME, Cummings C, Cunningham TM, Dossa RG, Brault M, Stokke J, Olsen TM, Gardner K, Estey E, Meshinchi S, Rongvaux A, Bleakley M. CBFB-MYH11 fusion neoantigen enables T cell recognition and killing of acute myeloid leukemia. J Clin Invest. 2020 Oct 1;130(10):5127-5141. doi: 10.1172/JCI137723.
- Background Blankenstein T, Leisegang M, Uckert W, Schreiber H. Targeting cancer-specific mutations by T cell receptor gene therapy. Curr Opin Immunol. 2015 Apr;33:112-9. doi: 10.1016/j.coi.2015.02.005. Epub 2015 Feb 27.
- Background Sahin U, Tureci O. Personalized vaccines for cancer immunotherapy. Science. 2018 Mar 23;359(6382):1355-1360. doi: 10.1126/science.aar7112.
- Background van der Lee DI, Reijmers RM, Honders MW, Hagedoorn RS, de Jong RC, Kester MG, van der Steen DM, de Ru AH, Kweekel C, Bijen HM, Jedema I, Veelken H, van Veelen PA, Heemskerk MH, Falkenburg JHF, Griffioen M. Mutated nucleophosmin 1 as immunotherapy target in acute myeloid leukemia. J Clin Invest. 2019 Feb 1;129(2):774-785. doi: 10.1172/JCI97482. Epub 2019 Jan 14.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | targeted AML1-ETO neoantigen cytotoxic T cells (CTL) | Cell therapy | 5e+07 cells | Other |
| Subject | targeted AML1-ETO neoantigen cytotoxic T cells (CTL) | Cell therapy | 1e+08 cells | Other |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Decitabine | Small molecule | — | — |
| Background | Mitoxantrone | Small molecule | — | — |