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New treatment option for AML
Official title A Phase 1/3 Study of T-Cell Receptor Engineered Donor T Cells in Subjects Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation
ClinicalTrials.gov ID: NCT05473910
What this study is testing
What is SOC + TSC-101?
SOC + TSC-101 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for aml.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Male Participants:
- A male participant must agree to use a highly effective contraceptive as detailed in Appendix 4 of this protocol during the intervention period and...
You likely can't join if
- Medical or psychological conditions that would make the participant an unsuitable candidate for cell therapy including another concurrent...
- The presence of organ toxicities will not necessarily exclude participants from enrolling on the protocol at the discretion of the PI; however, a...
- Participants who meet inclusion criteria for TSC-101 but who are also positive for HLAA\ 02:07.
- Participants with evidence of clinically significant infection or uncontrolled viral r reactivation of cytomegalovirus (CMV), Epstein-Barr virus...
- Participants with active cardiac disease, defined as:
- Uncontrolled or symptomatic angina within the past 3 months. History of clinically significant arrhythmias (such as ventricular tachycardia...
See the full eligibility criteria
- 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.
- Male Participants:
- 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...
- Female Participants:
- A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- Not a woman of childbearing potential (WOCBP) OR
- A WOCBP who agrees to follow the contraceptive guidance during the intervention period and for at least 12 months after the last dose of study intervention.
- Preparing to undergo allogeneic HCT for either of the following:
- AML, MDS, ALL
- Participants in the treatment arms must express HLA-A\ 0201. Participants in the control arm may express any HLA type.
- Having the HA1+/- or HA-1+/+ (HA-1 positive) genotype to be eligible for TSC-100 treatment.
- Having the HA2+/- HA-2+/+ (HA-2 positive) genotype to be eligible for TSC-101 treatment.
- Having a haploidentical donor, MMUD, or MUD for HCT who is adequately HLA-matched by institutional standards and meets the donor . Considered to be clinically indicated for haploidentical donor, MMUD, or MUD...
- 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...
- Participants who meet inclusion criteria for TSC-101 but who are also positive for HLAA\ 02:07.
- Participants with evidence of clinically significant infection or uncontrolled viral r reactivation of cytomegalovirus (CMV), Epstein-Barr virus (EBV), Adenovirus, BK virus (BKV), or human herpesvirus 6 (HHV-6).
- Participants with active cardiac disease, defined as:
- Uncontrolled or symptomatic angina within the past 3 months. History of clinically significant arrhythmias (such as ventricular tachycardia, ventricular fibrillation, torsades de pointes). Atrial fibrillation with...
- Myocardial infarction \< 3 months from study entry. Uncontrolled or symptomatic congestive heart failure. Prior allogeneic HCT. Participants who have a history of hypersensitivity to murine proteins. Enrollment on a...
- Donor Exclusion Criteria :
- Donors for TSC-100 positive for any HLA-A\ 02 allele would be excluded unless they are HA-1 negative. If donors with any HLA-A\ 02 allele are considered for patients eligible for TSC-100, the donor would undergo HA-1...
- Donors for TSC-101 positive for any HLA-A\ 02 allele are excluded regardless of HA- 2 status.
- Donors who test positive for any of the following: HIV-1, HIV-2, human T-lymphotropic virus (HTLV)-1, HTLV-2 seropositive or with active hepatitis B or hepatitis C virus infection, syphilis, West Nile virus through...
- Related donor residing outside of the United States of America (USA). If the donor screening, testing and leukapheresis can be performed at the same site where the participant is being treated, the donor is considered...
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Aurora, Colorado, United States
- Denver, Colorado, United States
- New Haven, Connecticut, United States
- Hollywood, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- Hackensack, New Jersey, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
- Austin, Texas, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Milwaukee, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Aurora, Colorado, United States; Denver, Colorado, United States; New Haven, Connecticut, United States; Hollywood, Florida, United States; Tampa, Florida, United States and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.