drugset / Trial / NCT06720324
CD7-specific CAR-T Cell in the Treatment of CD7-positive Relapsed/Refractory Hematologic Tumors
Phase 1/2
Recruiting
80 enrolled
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Hebei Taihe Chunyu Biotechnology Co., Ltd · collab
NaSingle-groupOpen-labelTreatment
Summary
This study is a single-center, open, prospective single-arm clinical study of patients with CD7 postive relapsed / refractoryhematological tumors to evaluate the safety and efficacy of CD7-specific CAR-T cells in relapsed / refractory hematological tumors while collecting pharmacokinetics and pharmacodynamics indicators of CAR-T cells.
Timeline
- Start
- 2024-12-31
- Primary completion
- 2027-12-31
- Completion
- 2027-12-31
Publications
- Background Sadelain M, Riviere I, Riddell S. Therapeutic T cell engineering. Nature. 2017 May 24;545(7655):423-431. doi: 10.1038/nature22395.
- Background Lee DW, Kochenderfer JN, Stetler-Stevenson M, Cui YK, Delbrook C, Feldman SA, Fry TJ, Orentas R, Sabatino M, Shah NN, Steinberg SM, Stroncek D, Tschernia N, Yuan C, Zhang H, Zhang L, Rosenberg SA, Wayne AS, Mackall CL. T cells expressing CD19 chimeric antigen receptors for acute lymphoblastic leukaemia in children and young adults: a phase 1 dose-escalation trial. Lancet. 2015 Feb 7;385(9967):517-528. doi: 10.1016/S0140-6736(14)61403-3. Epub 2014 Oct 13.
- Background Turtle CJ, Hanafi LA, Berger C, Gooley TA, Cherian S, Hudecek M, Sommermeyer D, Melville K, Pender B, Budiarto TM, Robinson E, Steevens NN, Chaney C, Soma L, Chen X, Yeung C, Wood B, Li D, Cao J, Heimfeld S, Jensen MC, Riddell SR, Maloney DG. CD19 CAR-T cells of defined CD4+:CD8+ composition in adult B cell ALL patients. J Clin Invest. 2016 Jun 1;126(6):2123-38. doi: 10.1172/JCI85309. Epub 2016 Apr 25.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CD7-specific CAR-T Cells | Cell therapy | 1e+06 cells/kg | — |
| Subject | CD7-specific CAR-T Cells | Cell therapy | 3e+06 cells/kg | — |
| Background | Cyclophosphamide | Other / unclassified | 300 mg/kg | — |
| Background | Fludarabine | Small molecule | 30 mg/kg | — |