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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)

20 de julho de 2026 atualizado por: 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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

310

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Marlyane Motta
  • Número de telefone: (857) 399-9887
  • E-mail: mmotta@tscan.com

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Não randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Medicamento: TSC-101
SOC + TSC-101
Comparador Ativo: 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.
Outro: Ao controle
SOC sozinho

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Relapse-free survival (RFS)
Prazo: 3 years
To determine the efficacy of TSC-101 by assessing relapse-free survival (RFS)
3 years

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Event-free survival (EFS)
Prazo: 3 years
To determine the efficacy of TSC-101 by event-free survival (EFS)
3 years
Overall survival (OS)
Prazo: 3 years
To determine the efficacy of TSC-101 by overall survival (OS)
3 years
Time to relapse (TTR)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 3 years
To determine the efficacy of TSC-101 by tracking changes over time in quality of life scores of FACT-BMT
3 years

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Incidence and severity of treatment-emergent adverse events
Prazo: 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
Prazo: 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
Prazo: 3 years
Assess non-relapse mortality (NRM) of TSC-101
3 years
Overall Response Rates
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 3 years
To determine the efficacy of TSC-101 retreatment infusion by Duration of response (DoR)
3 years
EFS post-retreatment
Prazo: 3 years
To determine the efficacy of TSC-101 retreatment infusion by EFS post-retreatment
3 years
OS post-retreatment
Prazo: 3 years
To determine the efficacy of TSC-101 retreatment infusion by OS post-retreatment
3 years
MRD positivity
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 1 year
To determine the healthcare utilization post-HCT by hospitalization days through one-year post-HCT.
1 year

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

TScan Therapeutics, Inc.

Investigadores

  • Diretor de estudo: Shrikanta Chattopadhyay, MD, TScan Therapeutics

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

18 de junho de 2026

Conclusão Primária (Estimado)

1 de junho de 2029

Conclusão do estudo (Estimado)

1 de junho de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

1 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

8 de julho de 2026

Primeira postagem (Real)

14 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

22 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

20 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Outros números de identificação do estudo

  • TSCAN-001 (Phase 3)

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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