GoFast CAR T-Cell Therapy for Recurrent Refractory B-Cell Lymphoma (NCT07670260) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
GoFast CAR T-Cell Therapy for Recurrent Refractory B-Cell Lymphoma
China9 participantsStarted 2026-06-30
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective Response Rate
Timeframe: Up to 12 weeks after CAR T-cell infusion