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

30 aprile 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

24

Fase

  • Fase 2
  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Weidong Han
  • Numero di telefono: +86-010-55499341
  • Email: hanwdrsw@163.com

Luoghi di studio

  • Cina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Cina, 100853
        • Reclutamento
        • Biotherapeutic Department of Chinsese PLA Gereral Hospital
        • Contatto:
        • Contatto:
          • Weidong Han, PH.D
          • Numero di telefono: +86 +86-010-66937463
          • Email: hanwdrsw@163.com

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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
Biologico: 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.
Droga: 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).
Droga: 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).
Altri nomi:
  • Fludarabina

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Adverse Event
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
PK(Pharmacokinetics):Number and Copy Number of QH101 cells
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 12 months
OS is defined as the time from QH101 infusion to the date of death.
12 months
Progression Free Survival (PFS)
Lasso di tempo: 12 months
PFS is defined as the time from the QH101 infusion date to the date of disease progression assessed by investigators.
12 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Chinese PLA General Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

15 maggio 2026

Completamento primario (Stimato)

30 giugno 2029

Completamento dello studio (Stimato)

31 dicembre 2031

Date di iscrizione allo studio

Primo inviato

30 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

30 aprile 2026

Primo Inserito (Effettivo)

6 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CHN-PLAGH-BT-100

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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