Table 1 Applications of novel agents and regimens
Agent | Regimen | Mechanism | Study | Patients | Donors | GvHD |
|---|---|---|---|---|---|---|
Abatacept | ABA/Tacrolimus +- PTCy | CD28:CD80/86 co-stimulation blockade | Single-center phase 1b-2 study (NCT04503616) | AML (n = 12) B-NHL (n = 9) ALL/CLL (n = 10) MDS (n = 5) Other (n = 15) | Matched and mismatched Related and unrelated | 13.7% Grade II-IV aGvHD 9.8% Grade II-IV cGvHD |
RGI-2001 | 100 ug/kg intravenous infusion weekly x 6 doses, starting on the day of transplant (Days 0, 7, 14, 21, 28, 35) + CNI + MTX/MMF | Cytokine-dependent Treg proliferation | Multi-center phase 2b study (NCT04014790) | AML (n = 27) ALL (n = 11) MDS (n = 7) | Matched related (n = 15) Matched unrelated (n = 28) Mismatched unrelated (n = 6) | 20.4% Grade II-IV aGvHD 14.3% moderate cGvHD |
Orca-T | Orca-T + tacrolimus (n = 124) /sirolimus (n = 3) | Polyclonal donor Tregs to control alloreactive immune responses | Single-center phase 2 study (NCT01660607) Multi-center Phase 1b study (NCT04013685) | AML (n = 62) ALL (n = 42) MPAL (n = 4) CML with prior blast crisis (n = 4) High risk MDS (n = 15) | Matched related (n = 66) Matched unrelated (n = 61) | 5% Grade III-IV aGvHD 6% moderate/severe cGvHD |
Orca-Q | Orca-Q + tacrolimus (PTCy was not permitted) | Deplete certain T-cell subsets (unreported) from the graft | Multi-center phase 1 study (NCT03802695) | AML (n = 11) ALL (n = 8) CML with blast crisis (n = 2) | Haplo (defined as ≥ 4/8 but < 7/8 matched) | 14% Grade II-IV aGvHD 6.3% mild cGvHD |