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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
SOC + TSC-101
DrugHA-2 positive or HA-1 negative
Control
Other interventionSOC alone
SOC + TSC-100
DrugHA-1 positive
Treatment groups
Trial outcomes
Primary outcomes
Occurrence of dose limiting toxicities
Number of DLTs observed in patients compared to the control arm
Occurrence of adverse events
Number of adverse events in patients compared to control arm
Secondary outcomes
Comparison of disease free survival in patients versus the control arm
Disease-free survival in patients versus the control arm at 6 months, defined as the time from date of transplant to death or relapse/progression, whichever comes first. Participants alive and disease free will be censored at the last follow-up.
Comparison of disease free survival in patients versus the control arm
Disease-free survival in patients versus the control arm at 12 months, defined as the time from date of transplant to death or relapse/progression, whichever comes first. Participants alive and disease free will be censored at the last follow-up.
Disease-free survival in patients versus the control arm at 18 months, defined as the time from date of transplant to death or relapse/progression, whichever comes first. Participants alive and disease free will be censored at the last follow-up.
Disease-free survival at Month 18 defined as the time from date of transplant to death or relapse/progression, whichever comes first. Participants alive and disease free will be censored at the last follow-up.
Comparison of disease free survival in patients versus the control arm
Disease-free survival in patients versus the control arm at 24 months, defined as the time from date of transplant to death or relapse/progression, whichever comes first. Participants alive and disease free will be censored at the last follow-up.
Other outcomes
Analysis of donor chimerism
Analysis of donor hematopoietic chimerism evaluated in bone marrow, whole unfractionated blood, or blood cell fractions, including CD3 and CD33 subsets.
Analysis of donor chimerism
Analysis of donor hematopoietic chimerism evaluated in bone marrow, whole unfractionated blood, or blood cell fractions, including CD3 and CD33 subsets.
Analysis of MRD
MRD status in bone marrow biopsies at Day 60
Analysis of MRD
MRD status in bone marrow biopsies at Day 100
Sponsors and contacts
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