GoFast CAR T-Cell Therapy for Recurrent Refractory B-Cell Lymphoma
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorChinese PLA General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Pregnant or breastfeeding women.
Active hepatitis B virus or hepatitis C virus infection.
HIV/AIDS infection.
Any uncontrolled active infection.
Trial design
Design model
Sequential
Treatments tested in this trial
GoFast CD19 CAR T Cells
Biological/VaccineGoFast 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.
Treatment groups
9 Participants
are divided into 3 treatment groupsGroup A: Dose Cohort 1: 0.3 × 10^6 Cells/kgExperimental treatment 1 intervention
Group B: Dose Cohort 2: 0.6 × 10^6 Cells/kgExperimental treatment 1 intervention
Group C: Dose Cohort 3: 1.2 × 10^6 Cells/kgExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective Response Rate
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.
Time frame
Up to 12 weeks after CAR T-cell infusionSecondary outcomes
1
Complete Remission Rate
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.
Time frame
Up to 12 weeks after CAR T-cell infusion2
Overall Survival
Overall survival is defined as the time from GoFast CD19 CAR T-cell infusion to death from any cause.
Time frame
Up to 52 weeks after enrollment3
Time to Progression
Time to progression is defined as the time from GoFast CD19 CAR T-cell infusion to documented disease progression.
Time frame
Up to 52 weeks after enrollment4
Disease-Free Survival
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.
Time frame
Up to 52 weeks after enrollmentSponsors and contacts
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Source ClinicalTrials.gov
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