drugset / Trial / NCT02650414
CD22 Redirected Autologous T Cells for ALL
Phase 1
Active not recruiting
41 enrolled
University of Pennsylvania
Children's Hospital of Philadelphia · collab
NaSingle-groupOpen-labelTreatment
Summary
This is a pilot study to determine the feasibility and safety of a single dose of autologous T cells expressing CD22 chimeric antigen receptors expressing tandem TCR-ζ and 4-1BB signaling domains (CART22/CART22-65s cells) in pediatric and young adult subjects with relapsed or refractory B cell acute lymphoblastic leukemia.
Timeline
- Start
- 2016-01-13
- Primary completion
- 2037-12
- Completion
- 2037-12
Outcome
Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)
paper The primary end point of these studies was to assess safety, and the secondary end point was antileukemic efficacy. PMID 33888899 ↗
Publications
- Myers RM, DiNofia AM, Li Y, Diorio C, Liu H, Wertheim G, Fraietta JA, Gonzalez V, Plesa G, Siegel DL, Iannone E, Shinehouse L, Brogdon JL, Taylor C, Jadlowsky JK, Hexner EO, Engels B, Baniewicz D, Callahan C, Ruella M, Aplenc R, Barz Leahy A, McClory SE, Rheingold SR, Wray L, June CH, Maude SL, Frey NV, Grupp SA. CD22-targeted chimeric antigen receptor-modified T cells for children and adults with relapse of B-cell acute lymphoblastic leukemia after CD19-directed immunotherapy. J Immunother Cancer. 2025 Apr 17;13(4):e011549. doi: 10.1136/jitc-2025-011549.
- Singh N, Frey NV, Engels B, Barrett DM, Shestova O, Ravikumar P, Cummins KD, Lee YG, Pajarillo R, Chun I, Shyu A, Highfill SL, Price A, Zhao L, Peng L, Granda B, Ramones M, Lu XM, Christian DA, Perazzelli J, Lacey SF, Roy NH, Burkhardt JK, Colomb F, Damra M, Abdel-Mohsen M, Liu T, Liu D, Standley DM, Young RM, Brogdon JL, Grupp SA, June CH, Maude SL, Gill S, Ruella M. Antigen-independent activation enhances the efficacy of 4-1BB-costimulated CD22 CAR T cells. Nat Med. 2021 May;27(5):842-850. doi: 10.1038/s41591-021-01326-5. Epub 2021 Apr 22.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CART22 | Cell therapy | 2e+06 cells/kg | — |
| Subject | CART22 | Cell therapy | 1e+07 cells/kg | — |
| Subject | CART22 | Cell therapy | 1e+08 cells | — |
| Subject | CART22 | Cell therapy | 5e+08 cells | — |
| Subject | CART22-65s | Cell therapy | 200000 cells/kg | — |
| Subject | CART22-65s | Cell therapy | 2e+06 cells/kg | — |
| Subject | CART22-65s | Cell therapy | 1e+07 cells/kg | — |
| Subject | CART22-65s | Cell therapy | 1e+07 cells | — |
| Subject | CART22-65s | Cell therapy | 1e+08 cells | — |
| Subject | CART22-65s | Cell therapy | 5e+08 cells | — |