Relapsed or Refractory B-Cell Non-Hodgkin LymphomaPhase 1NCT07910708
GN001 for Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma and B-Cell Acute Lymphoblastic Leukemia
A Phase 1 study testing GN001 in people with Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma and Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia, run by Department of Hematology,Rheumatology and Immunology,Pu'er People's Hospital at 2 sites in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma, Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia
- What is being tested?
- GN001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesChina
- Study dates
- 4 Aug 2026to Aug 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant or breastfeeding women
- Any condition that, in the investigator's judgment, makes the participant unsuitable for the study
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
The 920th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army
Kunming, Yunnan
Sanbin Wang, +86-871-64774294, wangsanbin2022@126.com
- Recruiting
Pu'er People's Hospital
Pu'er, Yunnan
Chaoen Zheng, +86-879-2122054, Zce163163@163.com
About this study
Official title: An Exploratory Clinical Study of GN001 in Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma and B-Cell Acute Lymphoblastic Leukemia
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.
- Conditions
- Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma, Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia
- Being tested
- GN001
- Medical subject headings
- Recurrence, Lymphoma, B-Cell, Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GN001Biological
Also called GN001 Injection
GN001 administered as a single intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| GN001 Dose-escalation Cohort 1 | Experimental | 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. Receives: Biological: GN001 |
| GN001 Dose-escalation Cohort 2 | Experimental | 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. Receives: Biological: GN001 |
| GN001 Dose-escalation Cohort 3 | Experimental | 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. Receives: Biological: GN001 |
| GN001 Dose-escalation Cohort 4 | Experimental | 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. Receives: Biological: GN001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicities (DLTs)
Measured: 28 days after GN001 infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start4 Aug 2026
- Primary completionAug 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory B-Cell Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Department of Hematology,Rheumatology and Immunology,Pu'er People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chao-en Zheng, Principal investigator, Pu'er People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07910708
- Sponsor's protocol ID
- FX-GN001-01-2026
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study of GN001 in Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma and B-Cell Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT07910708
- Acronym / sponsor ID
- FX-GN001-01-2026
- Conditions
- Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma, Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Department of Hematology,Rheumatology and Immunology,Pu'er People's HospitalUniversity, hospital or other
- Study start
- 4 Aug 2026 (actual)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GN001 Dose-escalation Cohort 1 | Experimental | Biological: GN001Participants 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. |
| GN001 Dose-escalation Cohort 2 | Experimental | Biological: GN001Participants 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. |
| GN001 Dose-escalation Cohort 3 | Experimental | Biological: GN001Participants 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. |
| GN001 Dose-escalation Cohort 4 | Experimental | Biological: GN001Participants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Pregnant or breastfeeding women
- Any condition that, in the investigator's judgment, makes the participant unsuitable for the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GN001Also: GN001 InjectionGN001 administered as a single intravenous infusion. | Biological | GN001 Dose-escalation Cohort 1, GN001 Dose-escalation Cohort 2, GN001 Dose-escalation Cohort 3, GN001 Dose-escalation Cohort 4 |
Primary outcome
Incidence of dose-limiting toxicities (DLTs)
Time frame: 28 days after GN001 infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The 920th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army
Kunming, China
Chao-en Zheng principal investigator
Pu'er People's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GN001 in people with Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma and Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia, run by Department of Hematology,Rheumatology and Immunology,Pu'er People's Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose-limiting toxicities (DLTs) (time frame: 28 days after GN001 infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.