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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)

2026年7月20日 更新者：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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

310

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前：Marlyane Motta
  • 電話番号：(857) 399-9887
  • メール：mmotta@tscan.com

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：非ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
薬：TSC-101
SOC + TSC-101
アクティブコンパレータ：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.
他の：コントロール
SOC単独

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Relapse-free survival (RFS)
時間枠：3 years
To determine the efficacy of TSC-101 by assessing relapse-free survival (RFS)
3 years

二次結果の測定

結果測定
メジャーの説明
時間枠
Event-free survival (EFS)
時間枠：3 years
To determine the efficacy of TSC-101 by event-free survival (EFS)
3 years
Overall survival (OS)
時間枠：3 years
To determine the efficacy of TSC-101 by overall survival (OS)
3 years
Time to relapse (TTR)
時間枠：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
時間枠：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
時間枠：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
時間枠：3 years
To determine the efficacy of TSC-101 by tracking changes over time in quality of life scores of FACT-BMT
3 years

その他の成果指標

結果測定
メジャーの説明
時間枠
Incidence and severity of treatment-emergent adverse events
時間枠：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
時間枠：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
時間枠：3 years
Assess non-relapse mortality (NRM) of TSC-101
3 years
Overall Response Rates
時間枠：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
時間枠：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
時間枠：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)
時間枠：3 years
To determine the efficacy of TSC-101 retreatment infusion by Duration of response (DoR)
3 years
EFS post-retreatment
時間枠：3 years
To determine the efficacy of TSC-101 retreatment infusion by EFS post-retreatment
3 years
OS post-retreatment
時間枠：3 years
To determine the efficacy of TSC-101 retreatment infusion by OS post-retreatment
3 years
MRD positivity
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：1 year
To determine the healthcare utilization post-HCT by hospitalization days through one-year post-HCT.
1 year

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

TScan Therapeutics, Inc.

捜査官

  • スタディディレクター：Shrikanta Chattopadhyay, MD、TScan Therapeutics

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年6月18日

一次修了 (推定)

2029年6月1日

研究の完了 (推定)

2029年6月1日

試験登録日

最初に提出

2026年7月1日

QC基準を満たした最初の提出物

2026年7月8日

最初の投稿 (実際)

2026年7月14日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月22日

QC基準を満たした最後の更新が送信されました

2026年7月20日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

キーワード

その他の研究ID番号

  • TSCAN-001 (Phase 3)

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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