Clinical trials in the United States infusing CAR+ T cells under IND
| . | Antigen . | Tumor target . | Viral-specific T cell . | Lympho-depletion . | CAR generation . | ClinicalTrial.gov identifier . | Enrolling . | SAE . | Gene transfer . |
|---|---|---|---|---|---|---|---|---|---|
| 1 | Kappa light chain | B-NHL and B-CLL | No | Yes | First and second | NCT00881920 | Yes | TBM | Virus |
| 2 | CD19 | Lymphoma/leukemia (B-NHL) and CLL | No | No | First and second | NCT00586391 | Yes | TBM | Virus |
| 3 | CD19 | Advanced B-NHL/CLL | Yes | No | First and second | NCT00709033 | Yes | TBM | Virus |
| 4 | CD19 | Lymphoma and leukemia | No | Yes | Second | NCT00924326* | Yes | TBM | Virus |
| 5 | CD19 | ALL (post-HSCT) | Yes | No | Second | NCT00840853 | Yes | TBM | Virus |
| 6 | CD19 | Follicular NHL | No | Yes | First | NCT00182650 | No | No | Electroporation |
| 7 | CD19 | CLL | No | Yes/no | Second | NCT00466531* | Yes | Yes (1 Death) | Virus |
| 8 | CD19 | B-NHL/leukemia | No | Yes | First and second | NCT00891215 | Yes | TBM | Virus |
| 9 | CD19 | B-cell leukemia, CLL and B-NHL | No | No | Second | NCT01087294 | Yes | TBM | Virus |
| 10 | CD19 | B-ALL | No | Yes | Second | NCT01044069 | Yes | TBM | Virus |
| 11 | CD19 | B-lymphoid malignancies | No | Yes | Second | NCT00968760 | No | TBM | Electroporation (SB system) |
| 12 | CD20 | Relapsed/refractory B-NHL | No | Yes | First | NCT00012207* | No | No | Electroporation |
| 13 | CD20 | Mantle cell lymphoma or indolent B-NHL | No | Yes | Third | NCT00621452 | Yes | TBM | Electroporation |
| 14 | GD2 | Neuroblastoma | Yes | Yes | First | NCT00085930* | Yes | No | Virus |
| 15 | CEA | Adenocarcinoma | No | No | First | NCT00004178 | No | No | Virus |
| 16 | PSMA | Prostate cancer | No | Yes | First | NCT00664196 | Yes | TBM | Virus |
| 17 | CD171/L1-CAM | Neuroblastoma | No | No | First | NCT00006480 | No | No | Electroporation |
| 18 | FR | Ovarian epithelial cancer | No | No | First | NCT00019136 | No | No | Virus |
| 19 | CEA | Stomach carcinoma | No | No | Second | NCT00429078 | Yes | TBM | Virus |
| 20 | CEA | Breast cancer | No | No | Second | NCT00673829 | Yes | TBM | Virus |
| 21 | CEA | Colorectal carcinoma | No | No | Second | NCT00673322 | Yes | TBM | Virus |
| 22 | IL-13Rα2 | Glioblastoma | No | NA | Second | NCT00730613 | No | No | Electroporation |
| 23 | ERBB2 (HER2/neu) | Metastatic cancer | No | Yes | Third | NCT00924287 | No | Yes (1 Death) | Virus |
| 24 | HER2/neu | Lung malignancy | Yes | No | Second | NCT00889954 | Yes | TBM | Virus |
| 25 | HER2/neu | Advanced osteosarcoma | No | No | Second | NCT00902044 | Yes | TBM | Virus |
| . | Antigen . | Tumor target . | Viral-specific T cell . | Lympho-depletion . | CAR generation . | ClinicalTrial.gov identifier . | Enrolling . | SAE . | Gene transfer . |
|---|---|---|---|---|---|---|---|---|---|
| 1 | Kappa light chain | B-NHL and B-CLL | No | Yes | First and second | NCT00881920 | Yes | TBM | Virus |
| 2 | CD19 | Lymphoma/leukemia (B-NHL) and CLL | No | No | First and second | NCT00586391 | Yes | TBM | Virus |
| 3 | CD19 | Advanced B-NHL/CLL | Yes | No | First and second | NCT00709033 | Yes | TBM | Virus |
| 4 | CD19 | Lymphoma and leukemia | No | Yes | Second | NCT00924326* | Yes | TBM | Virus |
| 5 | CD19 | ALL (post-HSCT) | Yes | No | Second | NCT00840853 | Yes | TBM | Virus |
| 6 | CD19 | Follicular NHL | No | Yes | First | NCT00182650 | No | No | Electroporation |
| 7 | CD19 | CLL | No | Yes/no | Second | NCT00466531* | Yes | Yes (1 Death) | Virus |
| 8 | CD19 | B-NHL/leukemia | No | Yes | First and second | NCT00891215 | Yes | TBM | Virus |
| 9 | CD19 | B-cell leukemia, CLL and B-NHL | No | No | Second | NCT01087294 | Yes | TBM | Virus |
| 10 | CD19 | B-ALL | No | Yes | Second | NCT01044069 | Yes | TBM | Virus |
| 11 | CD19 | B-lymphoid malignancies | No | Yes | Second | NCT00968760 | No | TBM | Electroporation (SB system) |
| 12 | CD20 | Relapsed/refractory B-NHL | No | Yes | First | NCT00012207* | No | No | Electroporation |
| 13 | CD20 | Mantle cell lymphoma or indolent B-NHL | No | Yes | Third | NCT00621452 | Yes | TBM | Electroporation |
| 14 | GD2 | Neuroblastoma | Yes | Yes | First | NCT00085930* | Yes | No | Virus |
| 15 | CEA | Adenocarcinoma | No | No | First | NCT00004178 | No | No | Virus |
| 16 | PSMA | Prostate cancer | No | Yes | First | NCT00664196 | Yes | TBM | Virus |
| 17 | CD171/L1-CAM | Neuroblastoma | No | No | First | NCT00006480 | No | No | Electroporation |
| 18 | FR | Ovarian epithelial cancer | No | No | First | NCT00019136 | No | No | Virus |
| 19 | CEA | Stomach carcinoma | No | No | Second | NCT00429078 | Yes | TBM | Virus |
| 20 | CEA | Breast cancer | No | No | Second | NCT00673829 | Yes | TBM | Virus |
| 21 | CEA | Colorectal carcinoma | No | No | Second | NCT00673322 | Yes | TBM | Virus |
| 22 | IL-13Rα2 | Glioblastoma | No | NA | Second | NCT00730613 | No | No | Electroporation |
| 23 | ERBB2 (HER2/neu) | Metastatic cancer | No | Yes | Third | NCT00924287 | No | Yes (1 Death) | Virus |
| 24 | HER2/neu | Lung malignancy | Yes | No | Second | NCT00889954 | Yes | TBM | Virus |
| 25 | HER2/neu | Advanced osteosarcoma | No | No | Second | NCT00902044 | Yes | TBM | Virus |
ALL indicates acute lymphoblastic leukemia; NHL, non-Hodgkin lymphoma; CLL, chronic lymphocytic leukemia; GD2, disialoganglioside; FR, alpha folate receptor; CEA, carcinoembryonic antigen; L1-CAM, L1 cell adhesion molecule; PSMA, prostate-specific membrane antigen; ERBB2, receptor tyrosine-protein kinase erbB-2; Her2, human epidermal growth factor receptor; HSCT, hematopoietic stem cell transplantation; NA, not available; SB, Sleeping Beauty; TBM, to be monitored; SAE, serious adverse event; and IND, investigational new drug.
Studies have been described to demonstrate a CAR-mediated antitumor effect based on reduction in tumor size. Other trials demonstrated a biologic effect of CAR+ T cells based on reduction in biologic markers of tumor activity.