Table 2.
Anti–TIM-3 agents and associated clinical trials in leukemia.
| Clinical trial identifier | Phase | Start date | Status | Cancer type (population, N) | Interventions and Combination | Primary Outcome Measures | Secondary Outcome Measures | ||
|---|---|---|---|---|---|---|---|---|---|
| NCT03066648 (88) | Ib | July 6, 2017 | Active, not recruiting | ND or R/R AML, HR-MDS (N≈243) | MBG453(alone) | Safety, DLTs | PK, ORR, etc. | ||
| +HMA | |||||||||
| +Anti-PD-1 | |||||||||
| +HMA+ Anti-PD-1 | |||||||||
| NCT03940352 | Ib | June 24, 2019 | Recruiting | AML, HR-MDS (N≈80) | MBG453 +HDM201 | Safety, DLTs | ORR, BOR, etc. | ||
| Venetoclax+HDM201 | |||||||||
| NCT04443751 (86) | I | September 10, 2020 | Recruiting | R/R-AML, HR-MDS(N≈42) | SHR-1702 | MTD,RP2D | Safety, PK, etc. | ||
| NCT03946670 (89) | II | June 4, 2019 | Active, not recruiting | HR-MDS (N≈127) | MBG453+HMA | CR rate, PFS | OS, EFS, etc. | ||
| Placebo+HMA | |||||||||
| NCT04150029 (89) | II | September 1, 2020 | recruiting | ND AML (N≈86) | MBG453+HMA+Venetoclax | Safety, DLTs CR rate | CR/CRi rate, OS, etc. | ||
| NCT04823624 | II | September 2021 | Not yet recruiting | LD-MDS (N≈20) | MBG453(alone) | ORR | OS, PFS, etc. | ||
| NCT04623216 | Ib/II | July 22, 2021 | recruiting | AML (MRD+/post-aHSCT) (N≈59) | Part 1 | MBG453 400mg Q4W | DLTs, R/R rate | III or IV aGVHD rate, etc. | |
| MBG453 800mg Q4W | |||||||||
| Part 2 | MBG453(age>18) | ||||||||
| MBG453(12>age>18) | |||||||||
| NCT04878432 | II | June 30, 2021 | Not yet recruiting | HR-MDS (N≈90) | MBG453 + HMA or INQOVI (oral decitabine)) | Safety | CR, mCR, etc. | ||
| NCT04812548 | II | May 24, 2021 | Not yet recruiting | HR-MDS (N≈76) | MBG453+HMA+Venetoclax | Safety, DLTs, CR rate | ORR, PFS, etc. | ||
| NCT04266301 | III | June 8, 2020 | recruiting | HR-MDS, CMML-2 (N≈500) |
MBG453+ Azacitidine | OS | Safety, CR, etc. | ||
| Placebo+ Azacitidine | |||||||||
| CTR20201781 | III | August 6, 2020 | recruiting | HR-MDS, CMML-2(N≈100) | MBG453+Azacitidine | OS | Safety, CR, etc. | ||
| Placebo+Azacitidine | |||||||||
AML, acute myeloid leukemia; aGVHD, acute graft versus host disease; BOR, best overall response; CMML-2, chronic myelomonocytic leukemia-2; CR, complete response; CRi, complete remission with incomplete hematologic recovery; DLTs, dose-limiting toxicities; EFS, event-free survival; HR-MDS, higher-risk myelodysplastic syndrome; HMA, hypomethylating agent, LD-MDS, lower risk MDS; mCR, marrow remission; MTD, maximum tolerated dose; ND, newly diagnosed; ORR, overall response rate; OS, overall survival; PD-1, programmed cell death 1; PFS, progression-free survival; PK, pharmacokinetic; R/R, relapsed/refractory; RP2D, recommended phase 2 dose; TIM-3, T-cell immunoglobulin domain and mucin domain 3.