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
Qualifiers
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
Treatments tested in this trial
- GoFast CD19 CAR T Cells
Treatment groups
9 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov