OncoMatch/Clinical Trials/NCT05473910
A Study of TSC-100 and TSC-101 in AML, ALL and MDS in Patients Undergoing Allogeneic Peripheral Blood Stem Transplantation
Is NCT05473910 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments including SOC + TSC-100 and SOC + TSC-101 for aml.
Treatment: SOC + TSC-100 · SOC + TSC-101 — 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
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: HLA-A A*0201 expression
Participants in the treatment arms must express HLA-A*0201. Participants in the control arm may express any HLA type.
Required: HMHA1 HA-1 positive genotype (HA1+/- or HA-1+/+)
Having the HA1+/- or HA-1+/+ (HA-1 positive) genotype to be eligible for TSC-100 treatment.
Required: HMHA2 HA-2 positive genotype (HA2+/- or HA-2+/+)
Having the HA2+/- HA-2+/+ (HA-2 positive) genotype to be eligible for TSC-101 treatment.
Excluded: HLA-A A*02:07 positive
Participants who meet inclusion criteria for TSC-101 but who are also positive for HLAA*02:07.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: allogeneic hematopoietic cell transplantation
Prior allogeneic HCT.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope · Duarte, California
- Yale · New Haven, Connecticut
- Memorial Healthcare System · Hollywood, Florida
- Northside Hospital · Atlanta, Georgia
- John Hopkins University · Baltimore, Maryland
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05473910 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior allogeneic hematopoietic cell transplantation disqualifies patients from enrollment.
Does this trial require HLA-A?
Yes, HLA-A A*0201 expression is a required biomarker for enrollment.
Does this trial require HMHA1?
Yes, HMHA1 HA-1 positive genotype (HA1+/- or HA-1+/+) is a required biomarker for enrollment.
Does this trial require HMHA2?
Yes, HMHA2 HA-2 positive genotype (HA2+/- or HA-2+/+) is a required biomarker for enrollment.
Are patients with HLA-A alterations eligible?
No. HLA-A A*02:07 positive is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify