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

25 juni 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Ingrijpend

Inschrijving (Geschat)

9

Fase

  • Vroege 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, 100071
        • Chinese PLA General Hospital
        • Contact:

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 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.

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: Niet-gerandomiseerd
  • Interventioneel model: Sequentiële toewijzing
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Biologisch: 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.
Andere namen:
  • CD19 CAR T-Cell Therapy
  • Autologous CD19 CAR T Cells
  • GoFast CD19CAR-T
  • CD19-Targeted CAR T Cells
Experimenteel: 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.
Biologisch: 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.
Andere namen:
  • CD19 CAR T-Cell Therapy
  • Autologous CD19 CAR T Cells
  • GoFast CD19CAR-T
  • CD19-Targeted CAR T Cells
Experimenteel: 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.
Biologisch: 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.
Andere namen:
  • CD19 CAR T-Cell Therapy
  • Autologous CD19 CAR T Cells
  • GoFast CD19CAR-T
  • CD19-Targeted CAR T Cells

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Objective Response Rate
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Complete Remission Rate
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

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 (Geschat)

30 juni 2026

Primaire voltooiing (Geschat)

30 september 2027

Studie voltooiing (Geschat)

30 juni 2028

Studieregistratiedata

Eerst ingediend

22 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

25 juni 2026

Eerst geplaatst (Werkelijk)

26 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

26 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

25 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • GoFast CD19CAR-T

Plan Individuele Deelnemersgegevens (IPD)

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

NEE

Beschrijving IPD-plan

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.

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 .

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