Non-hodgkin LymphomaPhase 1NCT06875063
GB5005 CART-cell Injection in the Treatment of Patients With CD19-positive RR B-NHL
A Phase 1 study testing GB5005 CART in people with Non-hodgkin Lymphoma and Refractory Lymphoma, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
Trial summary
To evaluate the safety and tolerability of GB5005 in patients with CD19-positive relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-hodgkin Lymphoma, Refractory Lymphoma, Chimeric Antigen Receptor T-cell
- What is being tested?
- GB5005 CART
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2026to 31 May 2027
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The candidate is able to communicate effectively with researchers and sign informed consent forms in writing;
- Age greater than or equal to 18 years old and less than or equal to 70 years old, regardless of gender; Sign informed consent form;
- Non Hodgkin lymphoma confirmed by cytology and genetics;
- Positive expression of CD19 in tumor cells confirmed by flow cytometry or pathological histology;
- When screening, it meets the definition of recurrence or refractory: having received at least second-line or above systemic anti-tumor therapy (including autologous hematopoietic stem cell transplantation) containing rituximab (or other CD20 targeted drugs) and anthracycline drugs in the past, and disease progression (PD) or recurrence after the last treatment; Or recurrent patients who do not fully meet the above conditions but refuse chemotherapy and strongly demand CAR-T treatment;
- There is no obvious evidence of central nervous system lymphoma on brain MRI;
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- Blood routine: Neutrophils ≥ 1.0 × 10 ^ 9/L; Hemoglobin ≥ 70 g/L; Platelets ≥ 50 × 10 ^ 9/L;
- Coagulation function: fibrinogen ≥ 1.0 g/L; Activated partial thromboplastin time (APTT) ≤ ULN+10 s, prothrombin time (PT) ≤ ULN+3 s;
- Liver and kidney function indicators: total bilirubin ≤ 1.5 times the upper limit of normal range (excluding Gilbert syndrome or hemolysis), ALT and AST ≤ 3.0 times the upper limit of normal range (ULN), serum creatinine ≤ 2.0 times the upper limit of normal range. If the above abnormalities are considered to be caused by tumor infiltration, they can be excluded;
- Assessment of left ventricular ejection fraction (LVEF) ≥ 45% using echocardiography (ECHO) or radionuclide active vascular scanning (MUGA). (After corrective treatment and meeting the criteria, it can be included in the group);
- Pulmonary function: Dyspnea ≤ CTCAE level 1 and SaO2 ≥ 92% in indoor air environment; 12. The physical fitness score of the Eastern Cooperative Oncology Group (ECOG) in the United States ranges from 0 to 2 points;
- Expected survival is greater than 6 months; 14. The subjects have sufficient levels of functional organs during screening;
- Female participants of childbearing age must undergo a serum pregnancy test during screening and before receiving pre-treatment chemotherapy, and the result must be negative. They are willing to use highly effective and reliable methods of contraception within one year after using the study treatment;
- Male participants who engage in active sexual activity with women with reproductive potential must be willing to use highly effective and reliable methods of contraception within one year after using the study treatment. Moreover, all males are strictly prohibited from donating sperm within one year after receiving research treatment infusion during the study period.
Who cannot join
- Patients with a history of allergies to serum albumin and DMSO in the past;
- Active hepatitis B virus (HBV) (HBV-DNA positive), hepatitis C virus antibody (HCV) (HCV-RNA positive), or human immunodeficiency virus (HIV) infection;
- Within the past 2 years, terminal organ damage caused by autoimmune diseases such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, or the need for systemic use of immunosuppressive or other systemic disease control drugs;
- History of unstable angina, myocardial infarction, coronary angioplasty, or significant heart disease within one year of enrollment;
- Primary central nervous system tumors or hematological tumors with central nervous system metastases;
- Uncontrolled mental illness;
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- Merge other life-threatening severe organ failure;
- Participated in other clinical studies within 4 weeks;
- Received live vaccination within 4 weeks of enrollment;
- Using prohibited drugs: a. Hormones: Corticosteroids (defined as>20mg/day prednisone or equivalent) used at therapeutic doses within 7 days prior to leukocyte collection. But the use of physiological substitutes, local and inhaled steroids is allowed. b. Chemotherapy: rescue chemotherapy, including tyrosine kinase inhibitors (TKIs), received within 1 week before leukocyte collection. c. Donor lymphocyte infusion (DLI) received within 4 weeks before leukocyte collection. d. graft-versus-host disease (GvHD) treatment: systemic anti GVHD treatment received within 3 months before GB5005 cell infusion. e. Alenumab used within 6 months before leukocyte collection, or chlorofarabin or cladribin used within 3 months. f. Checkpoint inhibitors or stimulants used before enrollment (excluding those with more than 3 biological half lives);
- Patients with known history of lung injury or hemorrhagic cystitis associated with cyclophosphamide treatment;
- Women who are already pregnant, preparing for pregnancy during the trial period, or breastfeeding;
- 13：As per the investigator's judgment, the subject is unlikely to complete all required visits or procedures stipulated in the protocol (including the follow-up period) or has insufficient compliance with the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Bing Xu
Xiamen, Fujian, 361000
Bing Xu, +8618750918842, xubingzhangjian@126.com
About this study
Official title: The Safety, Tolerability, Efficacy, and Pharmacokinetic Characteristics of GB5005 Chimeric Antigen Receptor T-cell Injection in Treating Patients With CD19-positive Relapsed/Refractory B-cell Non-Hodgkin Lymphoma (B-NHL).
To evaluate the safety and tolerability of GB5005 in patients with CD19-positive relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL).
Read the detailed description
Primary objectives: To evaluate the safety and tolerability of GB5005 in patients with CD19-positive relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL).
Secondary objectives: To assess the preliminary efficacy of GB5005 in patients with CD19-positive B-NHL; To describe the pharmacokinetic profile of GB5005 and observe its proliferation and persistence in the body; To explore the correlation between the pharmacokinetic characteristics of GB5005 and cytokine release syndrome (CRS) as well as neurological events.
- Being tested
- GB5005 CART
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GB5005 CARTDrug
Also called GB5005 chimeric antigen receptor T-cell injection
Included patients will receive GB5005 chimeric antigen receptor T-cell injection: A sterile syringe will be used to draw the assigned dose volume (calculated based on the patient's weight and converted to volume). The cells will be slowly infused intravenously at a rate of about 10 mL/min.
| Study group | Role | What they receive |
|---|---|---|
| Low dose group | Experimental | GB5005 chimeric antigen receptor T-cell injection（1 × 10 ^ 6 cells/kg） Receives: Drug: GB5005 CART |
| Median dose group | Experimental | GB5005 chimeric antigen receptor T-cell injection（2 × 10 ^ 6 cells/kg） Receives: Drug: GB5005 CART |
| Medium to high dose group | Experimental | GB5005 chimeric antigen receptor T-cell injection（3 × 10 ^ 6 cells/kg） Receives: Drug: GB5005 CART |
| High dose group | Experimental | GB5005 chimeric antigen receptor T-cell injection（5 × 10 ^ 6 cells/kg） Receives: Drug: GB5005 CART |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete remission (CR)
Complete remission rate was determined on the basis of investigator assessments according to 2014 Lugano criteria.
Measured: Up to 3 months
Secondary outcomes (2)
Recurrence free survival time (RFS)
Recurrence free survival time was defined as the time from the date of treatment initiation to the date of first documentation of definitive disease progression (PD) or date of death from any cause, whichever occurs first.
PFS was defined as the time from the date of treatment initiation to the date of first documentation of definitive disease recurrence or date of death from any cause, whichever occurs first.
PFS was defined as the time from the date of treatment initiation to the date of first documentation of definitive disease progression (PD) or date of death from any cause, whichever occurs first.
Measured: Up to 24 months
Overall survival（OS）
Overall survival will be measured from the date of registration to the date of the event (i.e., death) or the date of last follow-up to evaluate that event. Patients who are event-free at their last follow-up evaluation will be censored at that time point.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start30 Apr 2026 (estimated)
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Xiamen UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bing, Xu, The First Affiliated Hospital of Xiamen University
- Investigators
- Bing Xu, Principal investigator, The First Aiffiliated hosptical of xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06875063
- Sponsor's protocol ID
- XMDYYYXYK-17
- Status last verified
- Mar 2026
- First submitted
- 8 Mar 2025
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety, Tolerability, Efficacy, and Pharmacokinetic Characteristics of GB5005 Chimeric Antigen Receptor T-cell Injection in Treating Patients With CD19-positive Relapsed/Refractory B-cell Non-Hodgkin Lymphoma (B-NHL).
- ClinicalTrials.gov ID
- NCT06875063
- Acronym / sponsor ID
- XMDYYYXYK-17
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
- Study start
- 30 Apr 2026 (estimated)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 13 Mar 2025 (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.
To evaluate the safety and tolerability of GB5005 in patients with CD19-positive relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL).
Detailed description
Primary objectives: To evaluate the safety and tolerability of GB5005 in patients with CD19-positive relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL).
Secondary objectives: To assess the preliminary efficacy of GB5005 in patients with CD19-positive B-NHL; To describe the pharmacokinetic profile of GB5005 and observe its proliferation and persistence in the body; To explore the correlation between the pharmacokinetic characteristics of GB5005 and cytokine release syndrome (CRS) as well as neurological events.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low dose group | Experimental | Drug: GB5005 CARTGB5005 chimeric antigen receptor T-cell injection（1 × 10 ^ 6 cells/kg） |
| Median dose group | Experimental | Drug: GB5005 CARTGB5005 chimeric antigen receptor T-cell injection（2 × 10 ^ 6 cells/kg） |
| Medium to high dose group | Experimental | Drug: GB5005 CARTGB5005 chimeric antigen receptor T-cell injection（3 × 10 ^ 6 cells/kg） |
| High dose group | Experimental | Drug: GB5005 CARTGB5005 chimeric antigen receptor T-cell injection（5 × 10 ^ 6 cells/kg） |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- The candidate is able to communicate effectively with researchers and sign informed consent forms in writing;
- Age greater than or equal to 18 years old and less than or equal to 70 years old, regardless of gender; Sign informed consent form;
- Non Hodgkin lymphoma confirmed by cytology and genetics;
- Positive expression of CD19 in tumor cells confirmed by flow cytometry or pathological histology;
- When screening, it meets the definition of recurrence or refractory: having received at least second-line or above systemic anti-tumor therapy (including autologous hematopoietic stem cell transplantation) containing rituximab (or other CD20 targeted drugs) and anthracycline drugs in the past, and disease progression (PD) or recurrence after the last treatment; Or recurrent patients who do not fully meet the above conditions but refuse chemotherapy and strongly demand CAR-T treatment;
Key exclusion criteria (13 listed)
- Patients with a history of allergies to serum albumin and DMSO in the past;
- Active hepatitis B virus (HBV) (HBV-DNA positive), hepatitis C virus antibody (HCV) (HCV-RNA positive), or human immunodeficiency virus (HIV) infection;
- Within the past 2 years, terminal organ damage caused by autoimmune diseases such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, or the need for systemic use of immunosuppressive or other systemic disease control drugs;
- History of unstable angina, myocardial infarction, coronary angioplasty, or significant heart disease within one year of enrollment;
- Primary central nervous system tumors or hematological tumors with central nervous system metastases;
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 |
|---|---|---|
| GB5005 CARTAlso: GB5005 chimeric antigen receptor T-cell injectionIncluded patients will receive GB5005 chimeric antigen receptor T-cell injection: A sterile syringe will be used to draw the assigned dose volume (calculated based on the patient's weight and converted to volume). The cells will be slowly infused intravenously at a rate of about 10 mL/min. | Drug | High dose group, Low dose group, Median dose group, Medium to high dose group |
Primary outcome
Complete remission (CR)
Time frame: Up to 3 months
Complete remission rate was determined on the basis of investigator assessments according to 2014 Lugano criteria.
2 secondary outcomes
Recurrence free survival time (RFS)
Time frame: Up to 24 months
Overall survival（OS）
Time frame: Up to 24 months
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 13 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Bing Xu principal investigator
The First Aiffiliated hosptical of xiamen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GB5005 CART in people with Non-hodgkin Lymphoma and Refractory Lymphoma, run by The First Affiliated Hospital of Xiamen University at 1 site 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 14 inclusion and 13 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 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Bing Xu (18750918842, xubingzhangjian@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete remission (CR) (time frame: Up to 3 months). 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 13 Mar 2026.