drugset / Trial / NCT04088890
Autologous CD22 CAR T Cells in Adults w/ Recurrent or Refractory B Cell Malignancies
Phase 1
Completed
52 enrolled
Matthew Frank
American Society of Hematology · collabNational Cancer Institute (NCI) · collabThe Leukemia and Lymphoma Society · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The primary purpose of this study is to test whether CD22-CAR T cells can be successfully made from immune cells collected from adults with relapsed/refractory B-cell malignancies (leukemia and lymphoma).
Timeline
- Start
- 2019-09-12
- Primary completion
- 2024-11-07
- Completion
- 2025-03-07
Publications
- Frank MJ, Baird JH, Kramer AM, Srinagesh HK, Patel S, Brown AK, Oak JS, Younes SF, Natkunam Y, Hamilton MP, Su YJ, Agarwal N, Chinnasamy H, Egeler E, Mavroukakis S, Feldman SA, Sahaf B, Mackall CL, Muffly L, Miklos DB; CARdinal-22 Investigator group. CD22-directed CAR T-cell therapy for large B-cell lymphomas progressing after CD19-directed CAR T-cell therapy: a dose-finding phase 1 study. Lancet. 2024 Jul 27;404(10450):353-363. doi: 10.1016/S0140-6736(24)00746-3. Epub 2024 Jul 9.
- Baird JH, Frank MJ, Craig J, Patel S, Spiegel JY, Sahaf B, Oak JS, Younes SF, Ozawa MG, Yang E, Natkunam Y, Tamaresis J, Ehlinger Z, Reynolds WD, Arai S, Johnston L, Lowsky R, Meyer E, Negrin RS, Rezvani AR, Shiraz P, Sidana S, Weng WK, Davis KL, Ramakrishna S, Schultz L, Mullins C, Jacob A, Kirsch I, Feldman SA, Mackall CL, Miklos DB, Muffly L. CD22-directed CAR T-cell therapy induces complete remissions in CD19-directed CAR-refractory large B-cell lymphoma. Blood. 2021 Apr 29;137(17):2321-2325. doi: 10.1182/blood.2020009432.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CD22-CAR | Cell therapy | 300000 cells/kg | Intravenous |
| Subject | CD22-CAR | Cell therapy | 1e+06 cells/kg | Intravenous |
| Subject | CD22-CAR | Cell therapy | 3e+06 cells/kg | Intravenous |
| Subject | CD22-CAR | Cell therapy | 1e+07 cells/kg | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 500 mg/m2 | Intravenous |
| Background | Fludarabine | Small molecule | 30 mg/m2 | Intravenous |