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A Study of T-Cell Receptor Engineered Donor T Cells in Subjects Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation (ALLOHA-2)

2026년 7월 20일 업데이트: TScan Therapeutics, Inc.

A Phase 1/3 Study Evaluating the Efficacy and Safety of T-Cell Receptor Engineered Donor T Cells in Subjects Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation

This is a multicenter, genetically-randomized, controlled, Phase 3 study evaluating the efficacy and safety of T-cell receptor-engineered donor T cells targeting HA-2 (TSC-101) administered following reduced-intensity conditioning (RIC) hematopoietic cell transplantation (HCT) in participants with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS). The study will compare TSC-101 plus standard of care (SOC) versus SOC alone in participants undergoing allogeneic peripheral blood stem cell transplantation from haploidentical or mismatched unrelated donors.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

This is a multicenter, genetically-randomized, controlled, Phase 3 study designed to evaluate the efficacy and safety of TSC-101 in adult participants with AML or MDS undergoing allogeneic peripheral blood stem cell transplantation following reduced-intensity conditioning (RIC). TSC-101 is a donor-derived, genetically engineered T-cell therapy designed to express a therapeutic T-cell receptor recognizing the HA-2 minor histocompatibility antigen presented by HLA-A*02:01. The study is intended to evaluate whether administration of TSC-101 following transplantation can improve clinical outcomes compared with standard transplantation alone.

Eligible participants are adults with AML or MDS who are candidates for first allogeneic HCT using a haploidentical or mismatched unrelated donor and post-transplant. Participants assigned to the treatment arm must be HLA-A*02:01 positive, express HA-2, and have a study-eligible HLA-A*02-negative donor. Participants who are HLA-A*02:01 positive but do not have a study-eligible donor, as well as participants who are HLA-A*02:01 negative, may be assigned to the control arm.

Approximately 310 participants will be enrolled, with approximately 155 participants in each study arm. Participants assigned to the treatment arm will receive two infusions of TSC-101 following recovery after transplantation. The first infusion is planned approximately 21 days after HCT (Day +14 to Day +35), and the second infusion is planned approximately 40 days after the first infusion (40 to 68 days after Infusion 1).

All participants will receive SOC transplantation procedures, including one of several protocol-specified RIC regimens followed by peripheral blood stem cell transplantation and post-transplant cyclophosphamide (PTCy)-based graft-versus-host disease (GvHD) prophylaxis.

Safety will be monitored through ongoing review of adverse events, laboratory assessments, and clinical evaluations. An independent Data Safety Monitoring Board (DSMB) will periodically review safety data and study conduct and make recommendations regarding continuation, modification, or termination of the study.

This is an event-driven study. Participants will be followed for up to 3 years after HCT. Participants who receive at least one TSC-101 infusion will subsequently participate in a separate long-term follow-up study for up to 15 years following their final TSC-101 infusion to monitor long-term safety and survival outcomes.

연구 유형

중재적

등록 (추정된)

310

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Marlyane Motta
  • 전화번호: (857) 399-9887
  • 이메일: mmotta@tscan.com

연구 장소

  • 미국
    • Arizona
      • Gilbert, Arizona, 미국, 85234
        • 아직 모집하지 않음
        • Banner Health - MD Anderson Cancer Center
        • 수석 연구원:
          • Yazan Samhouri, MD
      • Scottsdale, Arizona, 미국, 85258
        • 아직 모집하지 않음
        • Honor Health Cancer Transplant Institute
        • 수석 연구원:
          • Abdullah Ladha, MD
    • California
      • Duarte, California, 미국, 91010
        • 모병
        • City of Hope
        • 수석 연구원:
          • Monzr M Al Malki, MD
      • Stanford, California, 미국, 94305
        • 아직 모집하지 않음
        • Stanford - School of Medicine
        • 수석 연구원:
          • Hany Elmariah, MD
    • Colorado
      • Aurora, Colorado, 미국, 80045
        • 모병
        • University of Colorado - Anschutz Cancer Center
        • 수석 연구원:
          • Mathew Angelos, MD
      • Denver, Colorado, 미국, 80218
        • 모병
        • SCRI - Colorado Blood Cancer Institute
        • 수석 연구원:
          • Marcello Rotta, MD
    • Connecticut
      • New Haven, Connecticut, 미국, 06510
        • 모병
        • Yale
        • 수석 연구원:
          • Lohith Gowda, MD
    • Florida
      • Hollywood, Florida, 미국, 33021
        • 모병
        • Memorial Cancer Institute
        • 수석 연구원:
          • Hugo Fernandez, MD
      • Tampa, Florida, 미국, 33612
        • 모병
        • Moffitt Cancer Institute
        • 수석 연구원:
          • Nelli Bejanyan, MD
    • Georgia
      • Atlanta, Georgia, 미국, 30342
        • 모병
        • Northside Hospital
        • 수석 연구원:
          • Melholm Sohl, MD
    • Illinois
      • Chicago, Illinois, 미국, 60607
        • 아직 모집하지 않음
        • University of Chicago
        • 수석 연구원:
          • Gregory Roloff, MD
    • Kansas
      • Kansas City, Kansas, 미국, 66160
        • 아직 모집하지 않음
        • The University of Kansas Cancer Center
        • 수석 연구원:
          • Rajat Bansal, MD
    • Maryland
      • Baltimore, Maryland, 미국, 21287
        • 모병
        • Johns Hopkins University
        • 수석 연구원:
          • Tania Jain, MD
    • Massachusetts
      • Boston, Massachusetts, 미국, 02114
        • 모병
        • Massachusetts General Hospital
        • 수석 연구원:
          • Yi-Bin Chen, MD
      • Boston, Massachusetts, 미국, 02215
        • 모병
        • Dana-Farber Cancer Institute - Hematology/Oncology
        • 수석 연구원:
          • Mahasweta Gooptu, MD
    • Michigan
      • Detroit, Michigan, 미국, 48201
        • 모병
        • Karmanos Cancer Institute
        • 수석 연구원:
          • Joseph Uberti, MD
    • New Jersey
      • Hackensack, New Jersey, 미국, 07601
        • 모병
        • Hackensack University Medical Center
        • 수석 연구원:
          • Michele Donato, MD
    • New York
      • New York, New York, 미국, 10029
        • 모병
        • Mount Sinai Hospital
        • 수석 연구원:
          • Alla Keyzner, MD
      • New York, New York, 미국, 10032
        • 모병
        • Columbia University - Irving Medical Center
        • 수석 연구원:
          • Ran Reshef, MD
    • North Carolina
      • Chapel Hill, North Carolina, 미국, 27599
        • 모병
        • The University of North Carolina at Chapel Hill
        • 수석 연구원:
          • Anson Snow, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, 미국, 19104
        • 모병
        • Hospital of the University of Pennsylvania
        • 수석 연구원:
          • Saar Gill, MD, PhD
    • Tennessee
      • Nashville, Tennessee, 미국, 37203
        • 모병
        • Sarah Cannon Research Institute - TriStar Bone Marrow Transplant (BMT)
        • 수석 연구원:
          • Jeremy Pantin, MD
    • Texas
      • Austin, Texas, 미국, 76704
        • 모병
        • St. David's South Austin Medical Center
        • 수석 연구원:
          • Uttam Rao, MD
      • Dallas, Texas, 미국, 75246
        • 모병
        • Baylor University Medical Center
        • 수석 연구원:
          • Luis Pineiro, MD
      • Houston, Texas, 미국, 76704
        • 모병
        • The University of Texas - MD Anderson Cancer Center
        • 수석 연구원:
          • Uday Popat, MD
    • Wisconsin
      • Milwaukee, Wisconsin, 미국, 53226
        • 모병
        • Froedtert & Medical College of Wisconsin
        • 수석 연구원:
          • Sameem Abedin, MD

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Subject Inclusion Criteria:

  1. Patient aged ≥ 18 years at the time of signing informed consent.
  2. Karnofsky Performance Status (KPS) ≥50 at the time of the screening visit.

  3. Undergoing first allo-HCT with a diagnosis of:

    • AML with bone marrow blasts < 5%, absence of circulating blasts, and absence of extramedullary disease.
    • MDS
  4. Must express HLA-A*02:01 as determined by pre-transplant institutional SOC work-up to be eligible for the treatment arm.
  5. Must have the HA-2 positive genotype to be eligible for the treatment arm.

  6. Undergoing RIC HCT using a haplo donor or MMUD.

    • Donors for treatment-arm subjects must be HLA-A*02-negative.
    • Donors for control-arm subjects do not have to be HLA-A*02-negative.
  7. Undergoing use of PTCy for GvHD prophylaxis at standard doses.
  8. Use of peripheral blood stem cell source.
  9. Organ function parameters for transplant eligibility are met per institutional standards. Where organ function may fall outside of institutional standard for transplant, and patient is still proceeding to transplant, the case should be reviewed and approved by the MedicalMonitor.
  10. Patient or legally authorized representative (LAR) capable of giving signed informed consent and willingness to comply with the requirements and restrictions listed in the informed consent form (ICF) and clinical protocol.
  11. Agrees to participate in long-term follow-up (LTFU) for up to 15 years post the final infusion of TSC-101 if they receive a TSC-101 infusion.

  12. Contraceptive use by male and female subjects must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. At a minimum:

    • A male subject must agree to use a highly effective contraceptive during the intervention period and for at least 12 months after the last TSC-101 infusion and refrain from donating sperm during this period.

    • A female subject 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) as defined in Appendix 2 OR
      • A WOCBP who agrees to follow the contraceptive guidance in Appendix 2 during the intervention period and for at least 12 months after the last TSC-101 infusion.

Subject Exclusion Criteria:

Patients are excluded from the study if any of the following criteria apply:

  1. Potential treatment-arm patient is positive for HLA-A*02:07.

    • Patients considered for the control arm can be positive for HLA-A*02 (including HLA-A*02:07).

  2. For patients with AML: those in third complete remission (CR3) or greater, partial remission, or with active AML disease.
  3. If patient required hemodialysis or mechanical ventilation within 3 months prior to enrollment, circumstances must be discussed with the Sponsor Medical Monitor.
  4. Prior allo-HCT.
  5. Use of anti-thymocyte globulin (ATG), alemtuzumab, or other in vivo or ex vivo T-cell depleting agents from Day -14 (pre-HCT) through end of study (EOS). Corticosteroids and maintenance therapies may be allowed under certain circumstances.
  6. History of hypersensitivity to murine proteins.
  7. Enrollment in a concomitant study with an investigational agent. All other concomitant trials must be reviewed and approved by the Medical Monitor.

  8. 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 controlled ventricular response on treatment is not an exclusion.
    • Myocardial infarction < 6 months from study entry.
    • Uncontrolled or symptomatic congestive heart failure.
    • Cardiac ejection fraction at rest of less than 40% or shortening fraction of less than 22% by echocardiogram or radionuclide scan (multi-gated acquisition [MUGA] scan).

  9. Medical or psychological conditions that would make the patient an unsuitable candidate for participation on a cell therapy trial, including active central nervous system disease and/or prior malignancy(s) within the last 3 years, except:

    • Lobular breast carcinoma in situ, fully resected basal cell or squamous cell carcinoma of skin or treated cervical carcinoma in situ will be allowed. Cancer treated with curative intent ≥ 3 years previously will be allowed

Donor Inclusion Criteria:

  1. Male or female ≥ 50 kg and aged ≥ 16 years at the time of signing informed consent who meet the criteria to donate as per the institutional SOC.
  2. Capable of giving signed informed consent, or assent/parental consent per institutional SOC, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
  3. For treatment-arm donors: able to undergo peripheral blood stem cell (PBSC) collection and at least 2 rounds of leukapheresis (for both TSC-101 manufacturing and the stem cell collection for HCT).
  4. For treatment-arm donors: negative for all HLA-A*02 alleles • Donors for control-arm subjects do not have to be negative for HLA-A*02 alleles.

Donor Exclusion Criteria:

  1. Donors for control-arm subjects who do not meet institutional standards for donor selection.

  2. Donors for treatment-arm subjects:

    • Who test positive for any of the following: human immunodeficiency virus (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 central lab testing. Donors who screen positive for Creutzfeldt Jakob disease using donor history questionnaires will also be excluded. Donors with evidence of past cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infections will be allowed.
    • For whom the treating Investigator deems subject level donor-specific HLA antibodies are high enough to warrant treatment with desensitization protocols.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위화되지 않음
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Treatment Arm (TSC-101)
Participants who are HLA-A*02:01-positive and undergoing reduced intensity conditioning hematopoietic stem cell transplantation using allogeneic HLA-A*02 negative donors.
의약품: TSC-101
SOC + TSC-101
활성 비교기: Control Arm (Standard of Care)
  1. Participants who are not HLA-A*02:01-positive, HA-2-positive, or who are treatment-arm eligible but for whom an HLA-A*02-negative donor cannot be identified, will be assigned to the control arm and receive allo-HCT alone.
  2. Participants who are HLA-A*02:01 negative, will be assigned to the control arm and receive allo-HCT alone.
다른: 제어
SOC 단독

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Relapse-free survival (RFS)
기간: 3 years
To determine the efficacy of TSC-101 by assessing relapse-free survival (RFS)
3 years

2차 결과 측정

결과 측정
측정값 설명
기간
Event-free survival (EFS)
기간: 3 years
To determine the efficacy of TSC-101 by event-free survival (EFS)
3 years
Overall survival (OS)
기간: 3 years
To determine the efficacy of TSC-101 by overall survival (OS)
3 years
Time to relapse (TTR)
기간: 3 years
To determine the efficacy of TSC-101 by assessing time to relapse (TTR)
3 years
Changes over time in Quality of Life Score - EQ-5D-5L
기간: 3 years
To determine the efficacy of TSC-101 by tracking changes over time in quality of life scores of EQ-5D-5L
3 years
Changes over time in Quality of Life Score - FACT-Leu
기간: 3 years
To determine the efficacy of TSC-101 by tracking changes over time in quality of life scores of FACT-Leu
3 years
Changes over Quality of Life Scores in FACT-BMT
기간: 3 years
To determine the efficacy of TSC-101 by tracking changes over time in quality of life scores of FACT-BMT
3 years

기타 결과 측정

결과 측정
측정값 설명
기간
Incidence and severity of treatment-emergent adverse events
기간: 3 years
To determine the safety and tolerability of TSC-101 through incidence and severity of treatment-emergent adverse events
3 years
TSC-101 Expansion and Persistence
기간: 3 years
To characterize the in vivo cellular pharmacokinetic (PK) profile of TSC-101 by analysis of peak persistence and other relevant PK parameters of TSC-101cells
3 years
Non-Relapse Mortality
기간: 3 years
Assess non-relapse mortality (NRM) of TSC-101
3 years
Overall Response Rates
기간: 3 years
To determine the efficacy of TSC-101 retreatment infusion through: overall response rates assessed by the Investigator.
3 years
MRD-negative CR in bone marrow
기간: 3 years
To determine the efficacy of TSC-101 retreatment infusion though analysis of the proportion of subjects achieving MRD-negative CR in bone marrow
3 years
Full Donor Chimerism
기간: 3 years
To determine the efficacy of TSC-101 retreatment infusion by analyzing the proportion of subjects achieving full donor chimerism.
3 years
Duration of response (DoR)
기간: 3 years
To determine the efficacy of TSC-101 retreatment infusion by Duration of response (DoR)
3 years
EFS post-retreatment
기간: 3 years
To determine the efficacy of TSC-101 retreatment infusion by EFS post-retreatment
3 years
OS post-retreatment
기간: 3 years
To determine the efficacy of TSC-101 retreatment infusion by OS post-retreatment
3 years
MRD positivity
기간: 3 years
To determine presence of and changes in minimal residual disease (MRD) by rates of MRD positivity pre-and post-HCT
3 years
Post-HCT conversion of MRD
기간: 3 years
To determine presence of and changes in minimal residual disease (MRD) by proportion of subjects with post-HCT conversion of MRD.
3 years
Changes in Donor Chimerism
기간: 3 years
To determine presence and changes of mixed chimerism and association with relapses by analyzing changes in donor chimerism over time.
3 years
Predictive Value of Donor Chimerism
기간: 3 years
To determine presence and changes of mixed chimerism and association with relapses through predictive value of mixed or full donor chimerism for relapse.
3 years
Healthcare Utilization post-HCT
기간: 1 year
To determine the healthcare utilization post-HCT by hospitalization days through one-year post-HCT.
1 year

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

TScan Therapeutics, Inc.

수사관

  • 연구 책임자: Shrikanta Chattopadhyay, MD, TScan Therapeutics

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 6월 18일

기본 완료 (추정된)

2029년 6월 1일

연구 완료 (추정된)

2029년 6월 1일

연구 등록 날짜

최초 제출

2026년 7월 1일

QC 기준을 충족하는 최초 제출

2026년 7월 8일

처음 게시됨 (실제)

2026년 7월 14일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 22일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 20일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

기타 연구 ID 번호

  • TSCAN-001 (Phase 3)

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다