About this trial
This is a multi-center, non-randomized, concurrent controlled, multi-arm, Phase 1 interventional, open-label, biologic assignment-based umbrella study evaluating the feasibility, safety and preliminary efficacy of an escalating dose regimen of up to 2 doses of TSC-100 and TSC-101 in patients with AML, MDS, or ALL following HCT from a haploidentical donor, MMUD, or MUD
Eligibility criteria
Qualifiers
Male or female aged ≥ 18 years at the time of signing the informed consent.
Eastern Cooperative Oncology Group (ECOG)-PS ≤ 2 at the time of the screening visit.
Contraceptive use by male and female participants must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
A male participant must agree to use a highly effective contraceptive as detailed in Appendix 4 of this protocol during the intervention period and for at least 12 months after the last dose of study intervention and refrain from donating sperm during this period.
Disqualifiers
None
Trial design
Treatments tested in this trial
- SOC + TSC-101
- Control
- SOC + TSC-100