Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Clinical Study of the Safety and Efficacy of Allogeneic TCR-enhanced Vδ2 T Cell in Patients With Malignant Tumors.

5 juni 2026 bijgewerkt door: Han weidong, Chinese PLA General Hospital

A Clinical Study on the Safety and Efficacy of Allogeneic TCR-enhanced Vδ2 T Cell Injection in the Treatment of Patients With Malignant Tumors

The allogeneic TCR-enhanced Vδ2 T cell product is a novel genetically engineered cellular therapeutic. By engineering a specific BTN protein-binding moiety on its cell surface, this product harnesses the intrinsic tumoricidal potential of endogenous Vδ2 T cells and augments BTN protein recognition capability, thereby significantly boosting tumor cell killing potency. Notably, this engineered cell product exhibits no expression of co-stimulatory signaling domains and CD3ζ domains. This design circumvents T cell exhaustion triggered by overactivation and markedly enhances the in vivo persistence of therapeutic cells.

This is an open, prospective, open-label Phase I/II clinical trial designed to assess the safety and therapeutic efficacy of allogeneic TCR-enhanced Vδ2 T cell injection in patients with relapsed or refractory hematologic malignancies and advanced solid tumors.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

24

Fase

  • Fase 2
  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100853
        • Werving
        • Biotherapeutic Department of Chinsese PLA Gereral Hospital
        • Contact:
        • Contact:
          • Weidong Han, PH.D
          • Telefoonnummer: +86 +86-010-66937463
          • E-mail: hanwdrsw@163.com

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  • Age 18-75 (inclusive).
  • Expected survival time ≥ 3 months.
  • Meets current clinical diagnostic criteria with a confirmed diagnosis of a malignant hematologic tumor or solid tumor, and has failed standard therapy (for solid tumors, at least one evaluable lesion according to RECIST v1.1 is required).
  • Adequate bone marrow reserve and essentially normal liver and kidney function (laboratory tests must meet the following criteria prior to the first allogeneic TCR-enhanced Vδ2 T cell treatment):
  • Hematology: White Blood Cell Count (WBC) ≥ 2.5×10⁹/L, Lymphocyte Count (LY) ≥ 0.8×10⁹/L, Hemoglobin (Hb) ≥ 80 g/L, Platelets (PLT) ≥ 75×10⁹/L.
  • Liver: ALT ≤ 3 × ULN; AST ≤ 3 × ULN; Total Bilirubin ≤ 3.0 × ULN.
  • Kidney: Serum Creatinine ≤ 1.5 × ULN.
  • Cardiac: Left Ventricular Ejection Fraction (LVEF) ≥ 50% as measured by echocardiogram.
  • Pulmonary: Normal oxygen saturation without supplemental oxygen.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1.
  • A negative pregnancy test is required for women of childbearing potential. Both male and female subjects must agree to use effective contraception during the treatment period and for 1 year thereafter.
  • Able to understand the trial requirements and is willing to participate in the clinical study as required.
  • Voluntarily signs the informed consent form for the clinical trial.

Exclusion Criteria:

  • Known history of allergy, hypersensitivity, intolerance, or contraindication to allogeneic TCR-enhanced Vδ2 T cell or any components of the study drugs (including fludarabine, cyclophosphamide and albumin paclitaxel).
  • Continuous use of immunosuppressants within 1 month prior to allogeneic TCR-enhanced Vδ2 T cell infusion.
  • History of cerebrovascular accident or seizure within 6 months prior to signing the informed consent.
  • Symptomatic brain metastases.
  • Known psychiatric or substance abuse disorders that would compromise compliance with study requirements.
  • Positive for Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb) with detectable Hepatitis B virus (HBV) DNA levels outside the normal reference range; positive for Hepatitis C virus (HCV) antibody with detectable HCV RNA; positive for Human Immunodeficiency Virus (HIV) antibody; positive for syphilis.
  • Severe cardiac disease, including but not limited to unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure (NYHA Class ≥ III), and severe arrhythmia.
  • Active or uncontrolled infection requiring systemic therapy (except for mild urogenital and upper respiratory tract infections).
  • Has not recovered from acute toxic effects of prior therapy (i.e., persisting hematological or organ toxicity ≥ Grade 2 related to prior therapy, excluding abnormalities associated with the study disease and its history).
  • Diagnosed with immunodeficiency.
  • Active infection requiring systemic treatment.
  • Female subjects of childbearing potential planning pregnancy within 2 years after cell infusion; or male subjects whose partners are planning pregnancy within 2 years after cell infusion.
  • Participation in another investigational drug clinical study within 1 month prior to screening.
  • Last anti-tumor therapy administered less than 5 half-lives of the drug prior to planned allogeneic TCR-enhanced Vδ2 T cell infusion.
  • Any other condition deemed by the investigator to make the subject unsuitable for participation in this study.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Patients with Relapsed/refractory hematologic malignancies and advanced solid tumor
A conditional chemotherapy regimen of fludarabine and cyclophosphamide(for patients with solid tumors, albumin paclitaxel will be used additionally) will be administered, followed by investigational therapy, allogeneic TCR-enhanced Vδ2 T cell.
Biologisch: Allogeneic TCR-enhanced Vδ2 T cell Injection

Allogeneic TCR-enhanced Vδ2 T cells in a standard 3+3 dose-escalation design. Three predefined dose levels are investigated:

Dose 1: 1×10^7 enTCR Vδ2T cells/kg, Dose 2: 3×10^7 enTCR Vδ2T cells/kg, and Dose 3: 6×10^7 enTCR Vδ2T cells/kg.

Geneesmiddel: Cyclophosphamide injection

For patients with hematological tumors, cyclophosphamide should be administered from day 5 to day 3 before cell infusion, with a recommended dose of 500 - 1000 mg/m² per day.

For patients with solid tumors, cyclophosphamide should be administered from day 4 to day 3 before cell infusion, with a recommended dose of 500 - 700 mg/m² per day.

Geneesmiddel: Fludarabine Injection

For patients with hematological tumors, fludarabine should be administered from day 5 to day 3 before cell infusion, and the recommended dose is 30 - 50 mg/m² per day.

For patients with solid tumors, fludarabine should be administered from day 4 to day 3 before cell infusion, with a recommended dose of 30 - 40 mg/m² per day.

Andere namen:
  • Fludarabine
Geneesmiddel: Albumin paclitaxel injection
This is only applicable to patients with solid tumors. It should be administered on the fifth day before cell infusion. The recommended dosage is 150-200 mg/m² per day.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Adverse Event
Tijdsspanne: 12 months
AE is defined as any adverse medical event from the date of leukapheresis to 12 months after allogeneic TCR-enhanced Vδ2 T cells infusion. Among them, cytokine release syndrome (CRS), immune cell-associated neurotoxicity syndrome (ICANS) , graft-versushost disease (GVHD) are excluded . Other AEs were graded according to the regulatory agency's Medical Dictionary for Regulatory Activities (MedDRA) and common terminology criteria for adverse events (CTCAE) v5.0
12 months
DLTs
Tijdsspanne: 28 days after cell infusion
DLT was defined as allogeneic TCR-enhanced Vδ2 T cells-related events with onset within first 28 days following infusion
28 days after cell infusion

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
PD(Pharmacodynamics):changes over time
Tijdsspanne: 12 months
To monitor changes over time in the cytokines mainly include interleukin-2 (IL-2 ), IL-4,IL-6, interferon-γ（IFN-γ), Tumor Necrosis Factor-alpha (TNF-α).
12 months
Objective Response Rate
Tijdsspanne: 12 months after cell infusion
The incidence of complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD) are the response to treatment assessed by investigators.
12 months after cell infusion
PK(Pharmacokinetics):Number and Copy Number of allogeneic TCR-enhanced Vδ2 T cell
Tijdsspanne: 12 months
Number and copy number of allogeneic TCR-enhanced Vδ2 T cells were assessed by number in peripheral blood.
12 months
Overall Survival(OS)
Tijdsspanne: 12 months
OS is defined as the time from allogeneic TCR-enhanced Vδ2 T cell infusion to the date of death.
12 months
Progression Free Survival (PFS)
Tijdsspanne: 12 months
PFS is defined as the time from the allogeneic TCR-enhanced Vδ2 T cell infusion date to the date of disease progression assessed by investigators.
12 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Chinese PLA General Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

5 juni 2026

Primaire voltooiing (Geschat)

30 juni 2029

Studie voltooiing (Geschat)

31 december 2031

Studieregistratiedata

Eerst ingediend

30 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

30 april 2026

Eerst geplaatst (Werkelijk)

6 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

8 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

5 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CHN-PLAGH-BT-100

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

Access to the data underlying this study can be obtained from the corresponding author upon reasonable request and subject to any required ethical approvals.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren