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.
Study summary
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Objective Response Rate — 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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