Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Clinical Study of the Safety and Efficacy of QH101 Cell in Patients With Malignant Tumors.

30. april 2026 opdateret af: Han weidong, Chinese PLA General Hospital

A Clinical Study on the Safety and Efficacy of QH101 Cell Injection in the Treatment of Patients With Malignant Tumors

QH101 is an allogeneic TCR-enhanced Vδ2 T cell therapeutic product. By introducing a specific BTN protein-binding moiety onto the cell surface, it leverages the inherent tumoricidal capacity of Vδ2 T cells and enhances their recognition of BTN proteins, thereby improving the killing efficiency against tumor cells. Meanwhile, QH101 does not express co-stimulatory signaling domains or the CD3ζ domain, which avoids cell exhaustion caused by excessive activation and effectively improves the persistence of cells in vivo.

This study is an open, prospective, open-label, phase I/II clinical trial designed to evaluate the safety and efficacy of QH101 Cell Injection in subjects with relapsed/refractory hematologic malignancies and advanced solid tumors.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

24

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100853
        • Rekruttering
        • Biotherapeutic Department of Chinsese PLA Gereral Hospital
        • Kontakt:
        • Kontakt:
          • Weidong Han, PH.D
          • Telefonnummer: +86 +86-010-66937463
          • E-mail: hanwdrsw@163.com

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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 QH101 treatment):
  • Hematology: White Blood Cell Count (WBC) ≥ 3×10⁹/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 QH101 or any components of the study drugs (including fludarabine and cyclophosphamide).
  • Continuous use of immunosuppressants within 1 month prior to QH101 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 QH101 infusion.
  • Any other condition deemed by the investigator to make the subject unsuitable for participation in this study.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Patients with Relapsed/refractory hematologic malignancies and relapsed/refractory solid tumor

A conditional chemotherapy regimen of fludarabine and cyclophosphamide will be administered, followed by investigational therapy, QH101 cell Interventions.

Biological: QH101 cell Injection Drug: Fludarabine and Cyclophosphamide
Biologisk: QH101 Cell Injection
Biological: QH101 cell Following lymphodepletion with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with dose escalation (3+3) : dose 1 (1×10^7 CAR+cells) ,dose 2 (3× 10^7 CAR+cells)，dose 3 (6× 10^7 CAR+cells). After the MTD and/or RP2D is determined in the dose escalation phase, a cohort expansion study may be initiated upon the investigator's decision. Enrolled subjects will receive QH101 infusion following lymphodepleting conditioning at the MTD and/or RP2D dose level established during the dose escalation phase.
Medicin: Cyclophosphamide injection
Eligible subjects will undergo lymphodepletion chemotherapy 5 to 3 days prior to cell infusion. The recommended lymphodepletion regimen comprises cyclophosphamide (500-1000 mg/m² administered 3 days).
Medicin: Fludarabine Injection
Eligible subjects will receive lymphodepletion chemotherapy 5 to 3 days prior to cell infusion. The recommended lymphodepletion regimen comprises fludarabine (30-50 mg/m² administered 3 days).
Andre navne:
  • Fludarabin

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Adverse Event
Tidsramme: 12 months
AE is defined as any adverse medical event from the date of leukapheresis to 12 months after QH101 cell 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
Tidsramme: 28 days after cell infusion
DLT was defined as QH101-related events with onset within first 28 days following infusion
28 days after cell infusion

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
PK(Pharmacokinetics):Number and Copy Number of QH101 cells
Tidsramme: 12 months
Number and copy number of QH101 cells were assessed by number in peripheral blood. Blood samples were collected before and one year after cell infusion (until QH101 cells were not detected for two consecutive times) to detect the number and copy number of QH101 cells, and to evaluate the pharmacokinetics of QH101.
12 months
PD(Pharmacodynamics):changes over time
Tidsramme: 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
Tidsramme: 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
Overall Survival(OS)
Tidsramme: 12 months
OS is defined as the time from QH101 infusion to the date of death.
12 months
Progression Free Survival (PFS)
Tidsramme: 12 months
PFS is defined as the time from the QH101 infusion date to the date of disease progression assessed by investigators.
12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Chinese PLA General Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

15. maj 2026

Primær færdiggørelse (Anslået)

30. juni 2029

Studieafslutning (Anslået)

31. december 2031

Datoer for studieregistrering

Først indsendt

30. april 2026

Først indsendt, der opfyldte QC-kriterier

30. april 2026

Først opslået (Faktiske)

6. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CHN-PLAGH-BT-100

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Solid tumor

Kliniske forsøg med QH101 Cell Injection

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Algeria

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner