Table 1.
The clinical trials of next generation of CAR-T cells in cancer immunotherapy
| Safety strategy | Target | Identifier | Disease | Treatment arms | Phase | Stage | Sponsor | Comments |
|---|---|---|---|---|---|---|---|---|
| EGFRt + cetuximab | CD19 | NCT02028455 | CD19+ acute leukemia | Anti-CD19 CAR-T/EGFRt | I/II | Recruiting | Seattle Children’s Hospital | To study the MTD and efficacy of CAR-T cells |
| NCT02146924 | High-risk ALL | Anti-CD19 CAR-T/EGFRt | I | Recruiting | City of Hope Medical Center | To study the side effects and best dose of CAR-T cells | ||
| NCT01815749 | Recurrent or high-risk NHL | Anti-CD19 CAR-T/EGFRt +auto-HSCT | I | Active, not recruiting | City of Hope Medical Center | To study the side effects and best dose of CAR-T cells | ||
| NCT03579888 | CD19+ lymphoid malignancies | Anti-CD19 CAR-T/EGFRt +Cyclophosphamide +Fludarabine | I | Not yet recruiting | M.D. Anderson Cancer Center | To study the side effects and best dose of CAR-T cells | ||
| NCT02051257 | Recurrent B-cell NHL | Anti-CD19 CAR-T/EGFRt | I | Active, not recruiting | City of Hope Medical Center | To study the highest dose of memory enriched T cells | ||
| NCT01865617 | R/R CLL, NHL or ALL | Anti-CD19 CAR-T/EGFRt | I/II | Recruiting | Fred Hutchinson Cancer Research Center | To study the side effects and best dose of CAR-T cells | ||
| NCT03103971 | R/R B-Cell NHL or ALL |
Anti-CD19 CAR-T/EGFRt +Cyclophosphamide +Fludarabine |
I | Recruiting | Fred Hutchinson Cancer Research Center | To study the side effects of CAR-T cells | ||
| NCT03085173 | R/R CLL | Anti-CD19 CAR-T/EGFRt | I | Recruiting | Memorial Sloan Kettering Cancer Center | To study the MTD of CAR-T cells | ||
| CD123 | NCT02159495 | CD123+ R/R AML and persistent/recurrent BPDCN |
Anti-CD123 CAR-T/EGFRt +Fludarabine |
I | Recruiting | City of Hope Medical Center | To study the side effects and the best dose of CAR-T cells | |
| NCT03114670 | Recurrent AML after allo-HSCT | Anti-CD123 CAR-T/EGFRt | I | Recruiting | Affiliated Hospital to Academy of Military Medical Sciences | To study the safety and effectiveness of CAR-T cells | ||
| CD22 | NCT03244306 | CD22+ leukemia | Anti-CD22 CAR-T/EGFRt | I | Active, not recruiting | Seattle Children’s Hospital | To study the safety and feasibility of CAR-T cells | |
| CD171 | NCT02311621 | Neuroblastoma | Anti-CD171 CAR-T/EGFRt | I | Recruiting | Seattle Children’s Hospital | To study the MTD of CAR-T cells | |
| EGFR | NCT03618381 | R/R solid tumors | Anti-EGFR CAR-T/EGFRt | I | Recruiting | Seattle Children’s Hospital | To study the safety, feasibility, and efficacy of CAR-T cells | |
| HER2 | NCT03500991 | HER2+ R/R pediatric CNS tumors | Anti-HER2 CAR-T/EGFRt | I | Recruiting | Seattle Children’s Hospital | To study the safety and feasibility of CAR-T cells via an indwelling CNS catheter | |
| BCMA | NCT03070327 | Multiple myeloma |
Anti-BCMA CAR-T/EGFRt +Cyclophosphamide +Lenalidomide |
I | Recruiting | Memorial Sloan Kettering Cancer Center | To study the safety of CAR-T cells | |
|
iCasp9+ AP1903 |
GD2 | NCT01822652 | Neuroblastoma | Anti-GD2 CAR-T/iCasp9 | I | Active, not recruiting | Baylor College of Medicine | To study the highest dose of CAR-T cells |
| NCT01953900 |
GD2+ osteosarcoma neuroblastoma |
Anti-GD2 CAR-T/iCasp9 | I | Recruiting | Baylor College of Medicine | To study the largest safe dose of CAR-T cells | ||
| NCT02107963 | GD2+ solid tumors |
Anti-GD2 CAR-T/iCasp9 +Cyclophosphamide |
I | Completed | National Cancer Institute | No results posted | ||
| NCT03721068 | Neuroblastoma |
Anti-GD2 CAR-T/IL-15/iCasp9 + Fludarabine +Cyclophosphamide |
I | Recruiting | UNC Lineberger Comprehensive Cancer Center | To study the safety and feasibility of CAR-T cells | ||
| CD19 | NCT03016377 | R/R ALL |
Anti-CD19 CAR-T/iCasp9 +Cyclophosphamide +Fludarabine |
I | Recruiting | UNC Lineberger Comprehensive Cancer Center | To study the safety and feasibility of CAR-T cells, and the optimal dose of AP1903 | |
| NCT03696784 | R/R B-cell lymphoma |
Anti-CD19 CAR-T/iCasp9 + Bendamustine +Fludarabine |
I | Not yet recruiting | UNC Lineberger Comprehensive Cancer Center | To study the safety and feasibility of CAR-T cells | ||
|
CD19 CD22 |
NCT03098355 |
B-cell leukemia and lymphoma |
Anti-CD19/22 CAR-T/iCasp9 + IL-2 | I/II | Recruiting | Zhujiang Hospital | To study the safety, efficacy and persistence of CAR-T cells | |
| CD30 | NCT02274584 | CD30+ lymphomas | Anti-CD30 CAR-T/iCasp9 | I/II | Recruiting | Peking University | To study the safety of CAR-T cells | |
| Mesothelin | NCT02414269 | Mesothelioma, lung cancer or breast cancer | Anti-mesothelin CAR-T/iCasp9 + Cyclophosphamide | I | Recruiting | Memorial Sloan Kettering Cancer Center | To study the safety of CAR-T cells | |
| TanCAR |
CD19 CD20 |
NCT03019055 | R/R CD19+ or CD20+ B-cell malignancies | Anti-CD19/20 CAR-T cells | I/II | Recruiting | Medical College of Wisconsin | To study the safety and feasibility of CAR-T cells |
| NCT03097770 | R/R B-cell leukemias and lymphomas | Anti-CD19/20-CAR-T cells | NA | Recruiting | Chinese PLA General Hospital | To study the safety and feasibility, and the duration of in vivo survival of tanCART-19/20 cells |
EGFRt: truncated epidermal growth factor receptor; MTD: maximum tolerated dose; CNS: central nervous system; AML: acute myeloid leukemia; BPDCN: blastic plasmacytoid dendritic cell neoplasm; Allo-HSCT: allogeneic hematopoietic stem cell transplantation; Auto-HSCT: autologous hematopoietic stem cell transplantation; ALL: acute lymphoblastic leukemia; NHL: non-Hodgkin’s lymphoma; CLL: chronic lymphoblastic leukemia; R/R: relapsed/refractory; NA: not applicable