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Wednesday, May 17, 2023 7:30:46 PM
Phase 1 umbrella clinical trial evaluating TSC-100 and TSC-101 targeting MiHAs HA-1 and HA-2, respectively, to treat residual disease and prevent relapse following HCT using RIC in patients with AML, MDS or ALL
Two control arm patients have been enrolled and received standard of care (SOC) (HCT alone):
Both control arm patients have medium-risk MDS and experienced incomplete donor chimerism (presence of patient-derived cells) following transplant
One patient is now in early stages of relapse: after 100 days, patient-derived cells are still observed and increasing
TSC-101 treatment arm (n=1 high-risk MDS with p53 mutation):
DL1 administered 21 days after transplant Engineered T cells showed expansion between 14-21 days after infusionDetectable markers of activation and proliferation observed
Twenty-one days after treatment and 42 days after transplant, donor chimerism was at 100% (no detectable patient-derived hematopoietic cells with sensitivity limit of 0.13%)
Minimal residual disease (MRD) assessment: p53 mutation was not detected post-transplant in bone marrow and peripheral blood samples, with sensitivity limit of 0.01%
No DLTs observed
Study advancing to DL2
TSC-100 treatment arm (n=1 T-cell ALL):
DL1 administered 28 days after transplant
T cell expansion occurred on Day 7 with detectable markers of T cell activation and proliferation
Two assays are used to detect the action of T cells:
MRD: SOC assays measuring remaining malignant cells use flow cytometry, which has a sensitivity of ~0.1% High sensitivity assay based on next-generation sequencing (NGS) and droplet digital PCR is also used in this study, with a sensitivity of 0.01%
Chimerism: SOC STR assays have ~1% sensitivity Study is using the high-sensitivity NGS-based Alloheme assay, with a sensitivity of ~0.13%
A copy of the poster can be accessed on the “Publications” section of the Company’s website at www.tscan.com.
https://www.otcmarkets.com/stock/TCRX/news/story?e&id=2531529
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