GN001 therapy for B-cell cancers that have come back or not responding

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 trial investigates the safety and tolerability of GN001, a lentiviral vector–based CAR T cell therapy administered by intravenous infusion in adults with CD19-positive relapsed or refractory B-cell malignancies. The study uses dose escalation with possible dose expansion after safety reviews and includes long-term safety follow-up. Outcomes include early signals of antitumor activity, expansion and persistence of CAR T cells, and biological responses to treatment. Participants must meet specific age, disease, and organ function criteria and provide informed consent. The trial is conducted at two sites in Yunnan, China, under a lead hematology, rheumatology, and immunology department.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Aged 18 to 75 years
* CD19-positive relapsed or refractory B-cell non-Hodgkin lymphoma or B-cell acute lymphoblastic leukemia
* Adequate organ function
* Signed informed consent

Exclusion Criteria:

* Pregnant or breastfeeding women
* Any condition that, in the investigator's judgment, makes the participant unsuitable for the study

Where it's running

• The 920th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army
  Kunming, Yunnan, China Recruiting
• Pu'er People's Hospital
  Pu'er, Yunnan, China Recruiting

Study contacts

• Principal investigator: Chao-en Zheng — Pu'er People's Hospital

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.