Phase | Clinical design | Clinical response | Author |
---|---|---|---|
I | Treatment: CD70-targeting allogeneic CAR-T cell therapy (CTX-130™). Protocol: Standard lymphodepleting chemotherapy with fludarabine 30 mg/m² and cyclophosphamide 500 mg/m² for 3 days, followed by CTX-130™ infusion at dose levels ranging from 3 × 107 to 9 × 108. | 7.7% durable CR (18 + months) and 69.2% SD (4 months). | Pal et al. 2022 [40] |
I | Treatment: Autologous T cells genetically retargeted against CAIX CD4 gamma-based CAR-T cells. Protocol: T cells expressing scFvG250-CD4 gamma receptor. Cohort 1: Inpatient up titration; max 8 IV infusions with 2 × 107 a 2 × 109 T cells each in two cycles, combined with 5 × 105 IU/m2 human rIL-2 SC, twice a day at days 1–10 and 17–26. Cohort 2: 3 × 3 Phase I approach, start dose: 1 × 108 T cells/ infusion at a maximum of 10 infusions in two cycles; combined with 5 × 105 IU/m2 human rIL-2 SC, twice a day at days 1–10 and 29–38. Cohort 3: same as cohort 2 plus pre-treatment with 5 mg anti-CAIX mAb G250 IV infusion 3 days before start each series of T cell infusions. | 12 patients with no clinical responses recorded. | |
I/II | Treatment: DC vaccination. Protocol: Antigen-pulsed autologous dendritic cells. Intranodal or intradermal vaccinations at a 1 × 107 dose (at least 6 vaccinations): 4 vaccinations: 1/27; 6 vaccinations: 14/27; 7–27 vaccinations: 12/27. Second vaccination was combined with 2 × 106 IU IL-2 SC (days 2–6) and 18/27 patients received 5% imiquimod topical (2–6 hs before vaccination). | Response after 8 weeks: 13/27 SD and 14/27 PD. Median overall survival: 16.6 months. | Berntsen et al. 2008 [43] |
I | Treatment: LANAK cells associated with IL-2 infusions. Protocol: IL-2 Cycles at 1-week intervals (at a daily dose of 16-20 × 106 IU/m2 infused alone for 48 h), apheresis 2 days after the end of each course, followed by reinfusion of LANAK cells (prepared in vitro) 2 weeks after apheresis + a 3-day cycle of 16-20 × 106 IU/m2IL-2 daily. | 3/10 PR, 4/10 CR and 1/10 SD with immunotherapy alone, and 2/10 CR after immunotherapy plus surgery. | Escudier et al. 1994 [44] |
I | Treatment: Autologous cell-therapy product based on γ9δ2 T cells (Innacell γδ™). Protocol: 3 cycles of 1-h intravenous infusion of γ9δ2 T cells with 3-week intervals (doses from 1 up to 8 × 109 cells), combined with IL-2 SC (2 × 106 IU/m2 from DAY 1 to 7) in the second and third cycles. | 6/10 SD, 4/10 PD and 25.7 weeks median time to progression. | Bennouna et al. 2008 [45] |
II | Treatment: LAK cells with human rIL-2. Protocol: 48/94 continuous infusion arm group: rIL-2 1 mg/m²/d IV infusion. LAK cells administered IV on days 11,12 and 14. 46/94 bolus injection group: rIL-2 33 µg/kg IV bolus infusion. LAK cells administered IV on days 11, 12 and 14. Both groups: one course of treatment every 3 months (3 courses total). | Bolus injection: 3/46 CR and 6/46 PR. Continuous infusion: 2/48 CR and 5/48 PR. | Weiss et al. 1992 [46] |
I | Treatment: Autologous CIK cells in combination with DCs and tyrosine kinase TKIs Protocol: Group 1: sunitinib/sorafenib monotherapy; Group 2: DCs + auto-CIKs + sunitinib/sorafenib | Significantly higher median PFS (28.0 vs. 11.0 months); 3-year OS rate (57.1% vs. 28.6%); more SD (11/15 vs. 6/19); less PD (8/15 vs. 9/19), and death (3 vs. 5) in group 2 compared to group 1. | Mai et al. 2018 [47] |
I | Treatment: Autologous CIK cells in combination with DCs and pembrolizumab (anti PD-1) Protocol: 31 patients assessed for response to treatment with DCs + auto-CIKs + pembrolizumab. All patients enrolled in trial were given the therapeutic. | 2/31 CR, 5/31 PR, 13/31 SD and 11/31 PD (1/8 CR, 1/8 PR, 4/8 SD, 2/8 PD in RCC); Overall disease control rate is 64.5% | Chen et al. 2018 [48] |