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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. Juli 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

310

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Arzneimittel: TSC-101
SOC + TSC-101
Aktiver Komparator: 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.
Sonstiges: Kontrolle
SOC allein

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Relapse-free survival (RFS)
Zeitfenster: 3 years
To determine the efficacy of TSC-101 by assessing relapse-free survival (RFS)
3 years

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Event-free survival (EFS)
Zeitfenster: 3 years
To determine the efficacy of TSC-101 by event-free survival (EFS)
3 years
Overall survival (OS)
Zeitfenster: 3 years
To determine the efficacy of TSC-101 by overall survival (OS)
3 years
Time to relapse (TTR)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 3 years
To determine the efficacy of TSC-101 by tracking changes over time in quality of life scores of FACT-BMT
3 years

Andere Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

TScan Therapeutics, Inc.

Ermittler

  • Studienleiter: Shrikanta Chattopadhyay, MD, TScan Therapeutics

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

18. Juni 2026

Primärer Abschluss (Geschätzt)

1. Juni 2029

Studienabschluss (Geschätzt)

1. Juni 2029

Studienanmeldedaten

Zuerst eingereicht

1. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

8. Juli 2026

Zuerst gepostet (Tatsächlich)

14. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

22. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

20. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • TSCAN-001 (Phase 3)

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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