A Phase 1 interventional study of GN001 in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma and Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia, sponsored by Department of Hematology,Rheumatology and Immunology,Pu'er People's Hospital. Recruiting at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Department of Hematology,Rheumatology and Immunology,Pu'er People's Hospital · Phase 1, Interventional, and Treatment
This study will evaluate GN001 in adults aged 18 to 75 years with CD19-positive relapsed or refractory B-cell non-Hodgkin lymphoma or B-cell acute lymphoblastic leukemia. GN001 is an investigational lentiviral vector-based treatment designed to generate CD19-targeted chimeric antigen receptor (CAR) T cells within the body.
The main purpose is to assess safety and tolerability at different doses. The study will also assess antitumor activity, the expansion and persistence of CAR T cells, and biological responses to treatment. Participants will receive GN001 by intravenous infusion. The study includes dose escalation and may include dose expansion after safety review. Long-term safety follow-up is planned.
This is the only study on the registry with Department of Hematology,Rheumatology and Immunology,Pu'er People's Hospital as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive GN001 at a dose of 1 x 10\^8 TU by intravenous infusion. This cohort starts with accelerated titration and may convert to a 3+3 design according to protocol-defined safety criteria.
Biological: GN001
Participants receive GN001 at a dose of 3 x 10\^8 TU by intravenous infusion. Enrollment follows a 3+3 dose-escalation design after review of the preceding cohort.
Biological: GN001
Participants receive GN001 at a dose of 7 x 10\^8 TU by intravenous infusion. Enrollment follows a 3+3 dose-escalation design after review of the preceding cohort.
Biological: GN001
Participants receive GN001 at a dose of 1 x 10\^9 TU by intravenous infusion. Enrollment follows a 3+3 dose-escalation design after review of the preceding cohort.
Biological: GN001
GN001 administered as a single intravenous infusion.
Also known as: GN001 Injection
Incidence of dose-limiting toxicities (DLTs)
Time frame: 28 days after GN001 infusion
Started Aug 2026 (actual). Primary completion is estimated for Aug 2029, 36 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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