A Study of TSC-100 and TSC-101 in AML, ALL and MDS in Patients Undergoing Allogeneic Peripheral Blood Stem Transplantation
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorTScan Therapeutics, Inc.
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
Medical or psychological conditions that would make the participant an unsuitable candidate for cell therapy including another concurrent uncontrolled malignancy or active CNS disease.
The presence of organ toxicities will not necessarily exclude participants from enrolling on the protocol at the discretion of the PI; however, a delay in the infusion of HA1/HA2 TCRT cells may be required at the discretion of the treating investigator
Participants with levels of donor-specific HLA antibodies that are considered by the treating investigator to be high enough to warrant desensitization protocols and who have no alternate donors.
Participants who meet inclusion criteria for TSC-101 but who are also positive for HLAA*02:07.
Trial design
Design model
Parallel
Treatments tested in this trial
SOC + TSC-100
DrugHA-1 positive
SOC + TSC-101
DrugHA-2 positive or HA-1 negative
Control
Other interventionSOC alone
Treatment groups
75 Participants
are divided into 3 treatment groupsGroup A: TSC-100 Treatment ArmExperimental treatment 1 intervention
Group B: TSC 101 Treatment ArmExperimental treatment 1 intervention
Group C: Standard of Care or Control armActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Occurrence of dose limiting toxicities
Number of DLTs observed in patients compared to the control arm
Time frame
two years2
Occurrence of adverse events
Number of adverse events in patients compared to control arm
Time frame
two yearsSecondary outcomes
1
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.
Time frame
6 months2
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.
Time frame
12 months3
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.
Time frame
18 months4
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.
Time frame
24 monthsOther outcomes
1
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.
Time frame
60 days2
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.
Time frame
100 days3
Analysis of MRD
MRD status in bone marrow biopsies at Day 60
Time frame
60 days4
Analysis of MRD
MRD status in bone marrow biopsies at Day 100
Time frame
100 daysSponsors and contacts
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Source ClinicalTrials.gov