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GoFast CAR T-Cell Therapy for Recurrent Refractory B-Cell Lymphoma

25. juni 2026 oppdatert av: Chunji Gao, Chinese PLA General Hospital

Exploratory Clinical Study of GoFast CAR T-Cell Platform Targeting CD19 CAR T-Cell Therapy for Recurrent Refractory B-Cell Lymphoma

This is an investigator-initiated, prospective, open-label exploratory clinical study designed to evaluate the safety and preliminary efficacy of GoFast CD19 CAR T-cell therapy in adult patients with recurrent or refractory B-cell lymphoma. Eligible patients will undergo screening, baseline assessment, peripheral blood or leukapheresis collection, lymphodepleting chemotherapy, and intravenous infusion of GoFast CD19 CAR T cells. The study plans to enroll 9 participants using a sequential dose-escalation design. The primary outcome is objective response rate, and secondary outcomes include complete remission rate, overall survival, progression-related survival outcomes, duration of response, MRD negativity, and adverse events.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This study will enroll adult patients with recurrent or refractory B-cell lymphoma who are CD19-positive and meet the protocol-defined eligibility criteria. After signing informed consent, participants will undergo screening assessments, including medical history, physical examination, performance status assessment, laboratory tests, infection screening, imaging evaluation, and assessment of feasibility for CAR T-cell preparation.

Eligible participants will undergo peripheral blood or leukapheresis collection for preparation of autologous GoFast CD19 CAR T cells. Before CAR T-cell infusion, participants will receive lymphodepleting chemotherapy with fludarabine 30 mg/m2 and cyclophosphamide 300 mg/m2 from Day -5 to Day -3. After completion of lymphodepletion, GoFast CD19 CAR T cells will be administered by intravenous infusion according to the assigned dose cohort.

The study uses a dose-escalation design with three planned dose cohorts: 0.3 × 10^6 cells/kg, 0.6 × 10^6 cells/kg, and 1.2 × 10^6 cells/kg. Each participant will receive a fixed dose according to the assigned cohort. Dose escalation will proceed only after review of safety data from the previous cohort and confirmation that no dose-limiting toxicity or other unacceptable safety signal has occurred.

Participants will be closely monitored after CAR T-cell infusion for adverse events, including cytokine release syndrome, neurotoxicity, tumor lysis syndrome, cytopenia, infection, organ dysfunction, and laboratory abnormalities. CAR T-cell expansion, lymphocyte subsets, cytokines, blood routine tests, biochemical tests, coagulation function, and organ function will be evaluated at protocol-defined time points.

Tumor response will be assessed using imaging and clinical evaluation at predefined follow-up visits, including Day 28 and Week 12 after CAR T-cell infusion. Participants with complete or partial response will continue follow-up for up to 1 year after enrollment. The primary endpoint is objective response rate. Secondary endpoints include complete remission rate, overall survival, time to progression, disease-free survival, duration of response, event-free survival, MRD negativity rate, and the incidence and severity of adverse events.

Studietype

Intervensjonell

Registrering (Antatt)

9

Fase

  • Tidlig fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100071
        • Chinese PLA General Hospital
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Age 18 years or older.
  • Histologically or cytologically confirmed primary refractory or relapsed/progressive large B-cell lymphoma.
  • Expected survival of more than 3 months.
  • CD19-positive B-cell lymphoma confirmed by flow cytometry or immunohistochemistry.
  • ECOG performance status of 0 to 2 or KPS score greater than 80.
  • Adequate venous access for leukapheresis or peripheral blood collection, with no contraindication to blood cell separation.
  • White blood cell count ≥ 1 × 10^9/L and lymphocyte count ≥ 0.3 × 10^9/L.
  • INR < 1.7 or prothrombin time prolonged by less than 4 seconds above the normal value.
  • ALT and AST ≤ 2.5 × upper limit of normal.
  • Total bilirubin ≤ 2.0 mg/dL, equivalent to 34.2 μmol/L.
  • Able to understand and voluntarily sign the written informed consent form.

Exclusion Criteria:

  • Pregnant or breastfeeding women.
  • Active hepatitis B virus or hepatitis C virus infection.
  • HIV/AIDS infection.
  • Any uncontrolled active infection.
  • Systemic corticosteroid use within 2 weeks before signing informed consent, except inhaled corticosteroids.
  • Active cardiac disease requiring treatment or poorly controlled hypertension.
  • Unstable or active ulcer disease or gastrointestinal bleeding.
  • History of organ transplantation or currently awaiting organ transplantation.
  • Central nervous system involvement by lymphoma.
  • Current participation in another clinical trial.
  • Any other condition that, in the investigator's judgment, makes the participant unsuitable for this clinical study.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Sekvensiell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Dose Cohort 1: 0.3 × 10^6 Cells/kg
Participants in this dose cohort will receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide, followed by intravenous infusion of GoFast CD19 CAR T cells at a dose of 0.3 × 10^6 cells/kg.
Biologisk: GoFast CD19 CAR T Cells
GoFast CD19 CAR T cells are autologous CD19-targeted chimeric antigen receptor T cells prepared using the GoFast CAR T-cell platform. Participants will receive lymphodepleting chemotherapy with fludarabine 30 mg/m2 and cyclophosphamide 300 mg/m2 from Day -5 to Day -3, followed by intravenous infusion of GoFast CD19 CAR T cells according to the assigned dose cohort: 0.3 × 10^6 cells/kg, 0.6 × 10^6 cells/kg, or 1.2 × 10^6 cells/kg.
Andre navn:
  • CD19 CAR T-Cell Therapy
  • Autologous CD19 CAR T Cells
  • GoFast CD19CAR-T
  • CD19-Targeted CAR T Cells
Eksperimentell: Dose Cohort 2: 0.6 × 10^6 Cells/kg
Participants in this dose cohort will receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide, followed by intravenous infusion of GoFast CD19 CAR T cells at a dose of 0.6 × 10^6 cells/kg.
Biologisk: GoFast CD19 CAR T Cells
GoFast CD19 CAR T cells are autologous CD19-targeted chimeric antigen receptor T cells prepared using the GoFast CAR T-cell platform. Participants will receive lymphodepleting chemotherapy with fludarabine 30 mg/m2 and cyclophosphamide 300 mg/m2 from Day -5 to Day -3, followed by intravenous infusion of GoFast CD19 CAR T cells according to the assigned dose cohort: 0.3 × 10^6 cells/kg, 0.6 × 10^6 cells/kg, or 1.2 × 10^6 cells/kg.
Andre navn:
  • CD19 CAR T-Cell Therapy
  • Autologous CD19 CAR T Cells
  • GoFast CD19CAR-T
  • CD19-Targeted CAR T Cells
Eksperimentell: Dose Cohort 3: 1.2 × 10^6 Cells/kg
Participants in this dose cohort will receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide, followed by intravenous infusion of GoFast CD19 CAR T cells at a dose of 1.2 × 10^6 cells/kg.
Biologisk: GoFast CD19 CAR T Cells
GoFast CD19 CAR T cells are autologous CD19-targeted chimeric antigen receptor T cells prepared using the GoFast CAR T-cell platform. Participants will receive lymphodepleting chemotherapy with fludarabine 30 mg/m2 and cyclophosphamide 300 mg/m2 from Day -5 to Day -3, followed by intravenous infusion of GoFast CD19 CAR T cells according to the assigned dose cohort: 0.3 × 10^6 cells/kg, 0.6 × 10^6 cells/kg, or 1.2 × 10^6 cells/kg.
Andre navn:
  • CD19 CAR T-Cell Therapy
  • Autologous CD19 CAR T Cells
  • GoFast CD19CAR-T
  • CD19-Targeted CAR T Cells

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Objective Response Rate
Tidsramme: Up to 12 weeks after CAR T-cell infusion
Objective response rate is defined as the proportion of participants who achieve complete response or partial response according to the 2014 Lugano lymphoma response criteria after GoFast CD19 CAR T-cell infusion.
Up to 12 weeks after CAR T-cell infusion

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Complete Remission Rate
Tidsramme: Up to 12 weeks after CAR T-cell infusion
Complete remission rate is defined as the proportion of participants who achieve complete response according to the 2014 Lugano lymphoma response criteria after GoFast CD19 CAR T-cell infusion.
Up to 12 weeks after CAR T-cell infusion
Overall Survival
Tidsramme: Up to 52 weeks after enrollment
Overall survival is defined as the time from GoFast CD19 CAR T-cell infusion to death from any cause.
Up to 52 weeks after enrollment
Time to Progression
Tidsramme: Up to 52 weeks after enrollment
Time to progression is defined as the time from GoFast CD19 CAR T-cell infusion to documented disease progression.
Up to 52 weeks after enrollment
Disease-Free Survival
Tidsramme: Up to 52 weeks after enrollment
Disease-free survival is defined as the time from achievement of response after GoFast CD19 CAR T-cell infusion to disease recurrence, disease progression, or death.
Up to 52 weeks after enrollment
Duration of Response
Tidsramme: Up to 52 weeks after enrollment
Duration of response is defined as the time from first documented complete response or partial response to disease progression, relapse, or death.
Up to 52 weeks after enrollment
Event-Free Survival
Tidsramme: Up to 52 weeks after enrollment
Event-free survival is defined as the time from GoFast CD19 CAR T-cell infusion to disease progression, relapse, initiation of new anti-lymphoma therapy, or death from any cause.
Up to 52 weeks after enrollment
MRD Negativity Rate
Tidsramme: Up to 12 weeks after CAR T-cell infusion
MRD negativity rate is defined as the proportion of participants who achieve minimal residual disease negativity after GoFast CD19 CAR T-cell therapy, as assessed by protocol-defined laboratory methods.
Up to 12 weeks after CAR T-cell infusion
Incidence and Severity of Adverse Events Assessed by CTCAE v4.03
Tidsramme: From informed consent to 52 weeks after enrollment
Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
From informed consent to 52 weeks after enrollment
Incidence and Severity of Cytokine Release Syndrome Assessed by ASTCT Consensus Criteria
Tidsramme: Up to 28 days after CAR T-cell infusion
Cytokine release syndrome will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading criteria.
Up to 28 days after CAR T-cell infusion
Incidence and Severity of Immune Effector Cell-Associated Neurotoxicity Syndrome Assessed by ASTCT Criteria
Tidsramme: Up to 28 days after CAR T-cell infusion
Immune effector cell-associated neurotoxicity syndrome (ICANS) will be graded according to ASTCT consensus criteria.
Up to 28 days after CAR T-cell infusion

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Chinese PLA General Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

30. juni 2026

Primær fullføring (Antatt)

30. september 2027

Studiet fullført (Antatt)

30. juni 2028

Datoer for studieregistrering

Først innsendt

22. juni 2026

Først innsendt som oppfylte QC-kriteriene

25. juni 2026

Først lagt ut (Faktiske)

26. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

26. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • GoFast CD19CAR-T

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Individual participant data will not be shared to protect participant privacy and confidentiality, particularly because this is a small exploratory CAR T-cell therapy study.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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