Table 1.
Clinical trials evaluating alternative immune cells for CAR-based cancer therapy
| National Clinical Trial identifier | Clinical trial phase | Cancer type | Antigen target | NK cell source | Construct/method | Dosage | Status | Location |
|---|---|---|---|---|---|---|---|---|
| Active CAR NK cell trials | ||||||||
| NCT03056339 | 1/2 | B-lymphoid malignancies, ALL, CLL, NHL | CD19 | Cord blood | CAR.CD19-CD28-CD3ζ-iCasp9-IL15 | 3 dosage levels: | Phase 1 portion completed, phase 2 recruiting | MD Anderson Cancer Center, Houston, TX USA |
| 105/kg | ||||||||
| 106/kg | ||||||||
| 107/kg | ||||||||
| NCT00995137 | 1 | B-ALL | CD19 | Haploidentical donor | CAR.19-41BB-CD3ζ | Unknown | Completed | St Jude Children’s Research Hospital, Memphis, TN |
| NCT04245722 | 1 | B-cell lymphoma, CLL | CD19 ± CD20 antibody (rituximab or obinutuzumab) | Induced pluripotent stem cell–derived NK cells | CAR.19-NKG2D-2B4-CD3ζ-IL15RF-hnCD16 | Dose escalation, exact dosages unknown | Recruiting | University of Minnesota Masonic Cancer Center, Minneapolis, MN |
| NCT03940833 | 1/2 | Multiple myeloma | BCMA | NK-92 cell line | Unknown | Unknown | Recruiting | China |
| NCT03415100 | 1 | Solid tumors | NKG2D ligands | Autologous or allogeneic NK | mRNA electroporation | Unknown | Recruiting | China |
| NCT03940820 | 1/2 | Solid tumors | ROBO1 | Unknown | Unknown | Recruiting | China | |
| NCT03941457 | 1/2 | Pancreatic cancer | ROBO1 | Unknown | Unknown | Unknown | Recruiting | China |
| NCT03383978 | 1 | Glioblastoma | HER2 | NK-92 | CAR.HER2-CD28- CD3ζ | 1 × 107-1 × 108 intracranial infusion | Recruiting | Germany |
| CAR-NK T cell trials | ||||||||
| NCT03774654 | 1 | Relapsed or refractory B-cell malignancies | CD19 | Allogeneic iNKT cells | CAR.19-CD28- CD3ζ -IL15 | 4 dosage levels: | Not yet recruiting | Baylor Methodist–Texas Children’s, Houston, TX |
| 1 × 107/m2 | ||||||||
| 3 × 107/m2 | ||||||||
| 1 × 108/m2 | ||||||||
| 3 × 108/m2 | ||||||||
| NCT03294954 | 1 | Relapsed or refractory neuroblastoma | GD2 | Autologous iNKT cells | CAR.GD2-CD28-CD3ζ-IL15 | 4 dosage levels: | Recruiting | Baylor Methodist–Texas Children’s, Houston, TX |
| 3 × 106/m2 | ||||||||
| 1 × 107/m2 | ||||||||
| 3 × 107/m2 | ||||||||
| 1 × 108/m2 | ||||||||
| CAR γδ T cell trials | ||||||||
| NCT02656147 | 1 | B-cell leukemia and lymphoma | CD19 | Allogeneic | Unknown | Unknown | Not yet recruiting | China |
| γδ T cells | ||||||||
| NCT04107142 | 1 | Solid tumors | NKG2D ligands | Haploidentical or allogeneic γδ T cells | Unknown | 3 × 108- | Not yet recruiting | Malaysia |
| 3 × 109 cells | ||||||||
| CAR CIK trial | ||||||||
| NCT03389035 | 1/2 | Relapsed B-ALL | CD19 | Allogeneic (donor derived peripheral blood) CIK | CAR.19-CD28-OX40- CD3ζ | 4 dose levels: 1 × 106, 3 × 106 | Recruiting | Italy |
| Sleeping beauty transposon | 7.5 × 106 | |||||||
| 15 × 106 | ||||||||
| CAR+ cells/kg | ||||||||
ALL, acute lymphoblastic leukemia; BCMA, B-cell maturation antigen; CLL, chronic lymphocytic leukemia; iCasp9, inducible caspase 9; mRNA, messenger RNA; NHL, non-Hodgkin lymphoma.