Table 3. Summary of Clinical Trials Using Non- Receptor Engineered T cells for Hematological Malignancies.
| Trial # | Intervention | Tumor Target | Primary Outcome | Secondary Outcome | Enrollment |
|---|---|---|---|---|---|
| NCT01627275 | Naive T Cell Depleted DLI | N/A | MTD | Immunological recovery; incidence of aGVHD, cGVHD & opportunistic infections | 28 |
| NCT00675831 | CD25+ Depleted DLI | N/A | Feasibility of CliniMACS to engineer CD25- product; Safety; | Clinical response; Immunological Impact | 24 |
| NCT02203903 (RESOLVE) | Tumor associated antigen lymphocytes (TAA-CTL) | PRAME, WT-1, survivin | Safety | TAA-CTL responses | 11 |
| NCT00052598 | Allogeneic CD8+CTL clones+aldesleukin (IL-2) | PR3 | Toxicity | Persistence; migration to BM; duration of response; proportion of responders | 7 |
| NCT00052520 | Allogeneic CD8+CTL clones+aldesleukin (IL-2) | WT-1 | Toxicity | Relapse | 37 |
| NCT00107354 | Allogeneic CD8+ C TL clones+aldesleukin (IL-2) | mHAg | Toxicity | Persistence; migration to BM; Antileukemic activity | NP |
| NCT02895412 (INTACT-WT1) | Allogeneic C TLs | WT-1 & multiple pathogens (CMV,Adv, EBV, VZV, IFV, BKV, fungal infections) | TRAE | N/A | 20 |
| NCT02074657 (LANK-2) | Activ ated and expanded natural killer cells (NKAEs) | N/A | Safety | Febrile neutropenia, or infection incidence; hematological recovery; ORR; immune reconstitution | 13 |
| NCT00620633 | Allogeneic C TLs | WT-1 | Toxicity | Disease progression; CTL survival & proliferation | 22 |
| NCT00460629 | Prophylactic donor CTLs | LAA | Feasibility; kinetics of BCR-ABL load; | Rates of aGVHD, cGVHD & infections | 20 |
| NCT00002663 | Allogeneic C TLs | EBV | Efficacy; expansion & duration; durability of response (time) | N/A | 84 |
| NCT01948180 (CITADEL) | Autologous T cells | EBV | ORR | CRR; Response Duration; time to response; PFS; DFS; OS; AEs | 35 |
| NCT00779337 | Autologous CTLs | EBV (AdE1- Latent Membrane Protein) | Feasibility; safety; reconstitution of EBV-specific CTL immunity with anti-viral efficacy | Optimal dose; clinical efficacy | 8 |
| NCT00005606 | Allogeneic CTLs | EBV | NP | NP | 10-20 |
| NCT01636388 | Allogeneic CTLs | EBV (LMP) | Safety, toxicity | Feasibility | 45 |
| NCT01956084 | Third party CTLs | EBV (LMP) | DLT | Survival & function of LMP-specific CTLs | 24 |
| NCT02057445 | Allogeneic CTLs | EBV | Safety; development of bank of third-party CTLs | Response rate | 18 |
| NCT01498484 | Allogeneic CTLs | EBV | Efficacy | In vivo expansion and duration of EBV-CTLs; durability of response | 112 |
| NCT01447056 | Allogeneic CTLs | EBV (LMP) | DLT; safety | Safety of dosing; immune function of CTLs; dz response | 18 |
| NCT01555892 (GRALE) | CTLs | EBV (LMP, BARF1 & EBNA1) | Toxicity | Survival and immune function of LMP/BARF1/EBNA1-specific CTLs; anti-viral and anti-tumor effects of CTLs | 136 |
| NCT00062868 | CTLs | EBV (LMP1/2) | DLT | Survival and immune function of LMP1/2-specific CTLs; anti-viral load and anti-tumor effects | 89 |
| NCT02287311 (MABEL) | Allogeneic CTLs | EBV (LMP, BARF1 And EBNA1) | DLT | Persistence; proliferation in vivo; CTL response to viral antigens; CR; PR | 42 |
| NCT00002663 | Allogeneic CTLs | EBV | Efficacy; In vivo ex pansion and duration; durability of clinical responses | N/A | 84 |
| NCT02973113 (PREVALE) | CTLs+Nivolumab | EBV | DLT | Duration of response; | 36 |
| NCT01333046 (TACTAL) | C TLs+/- 5-azacytidine | NY-ESO-1, MAGEA4, PRAME, Survivin and SSX | Safety (AEs/SAEs) | expansion, persistence and anti-tumor effects of CTLs; epitope spreading; | 74 |
TAAT: Tum or Associated Antigen –specific T cells; DLI: Donor Lymphocyte Infusion; MTD: maximum tolerated dose; BM: bone marrow; CTL: Cytotoxic T Lymphocytes; mHAg: minor histocompatibility antigen; NP: Not Provided; TRAE: Treatment-Related Adverse Events; cytomegalovirus (CMV), Adenovirus (Adv), Epstein Barr virus (EBV), Varicella-Zoster virus (VZV), Influenza, BK virus (BKV), and fungal infections; LAA: Leukemia-Associated Antigens; ORR: Overall Response Rate; CRR: Complete Response Rate; PFS: Progression Free Survival; DFS: Disease Free Survival; OS: Overall Survival; AEs: Adverse Events; DLT: Dose Limiting Toxicity;