CELL INTELLIGENCE · 肿瘤细胞治疗研究

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.

主要终点：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. · Up to 12 weeks after CAR T-cell infusion
次要终点：Complete Remission Rate；Overall Survival；Time to Progression；Disease-Free Survival；Duration of Response；Event-Free Survival；MRD Negativity Rate；Incidence and Severity of Adverse Events Assessed by CTCAE v4.03

• Dose Cohort 1: 0.3 × 10^6 Cells/kg · EXPERIMENTAL · 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.
• Dose Cohort 2: 0.6 × 10^6 Cells/kg · EXPERIMENTAL · 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.
• Dose Cohort 3: 1.2 × 10^6 Cells/kg · EXPERIMENTAL · 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.

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.