Clinical trial · Interventional
GoFast CAR T-Cell Therapy for Recurrent Refractory B-Cell Lymphoma
Exploratory Clinical Study of GoFast CAR T-Cell Platform Targeting CD19 CAR T-Cell Therapy for Recurrent Refractory B-Cell Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed or Refractory Large B-cell Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GoFast CD19 CAR T Cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Dose Cohort 1: 0.3 × 10^6 Cells/kg
- description
- 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.
- interventionNames
- Biological: GoFast CD19 CAR T Cells
- type
- EXPERIMENTAL
- label
- Dose Cohort 2: 0.6 × 10^6 Cells/kg
- description
- 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.
- interventionNames
- Biological: GoFast CD19 CAR T Cells
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available