EBV Associated Lymphoid NeoplasmsPhase 1/2ANXIN-02NCT07306156
GP350 CAR-T for Relapse/Refractory and Epstein-Barr Virus Infection Associated Lymphoid Neoplasms
A Phase 1/2 study testing GP350 CAR-T in people with EBV Associated Lymphoid Neoplasms, run by Zhimin Zhai at 1 site in China.
Trial summary
This is a Phase 1/Phase 2 open-label, single-arm clinical study of GP350 CAR-T for Relapse/Refractory and Epstein-Barr virus infection associated lymphoid neoplasms. Each participant will undergo leukapheresis after enrolment, receive treatment of the conditioning chemotherapy, and an intravenous infusion of CAR-T… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- EBV Associated Lymphoid Neoplasms
- What is being tested?
- GP350 CAR-T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2025to 20 Nov 2032
- Phase
- Phase 1/2
- 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
- Diagnosis: Confirmed diagnosis of lymphoid neoplasms according to WHO-HAEM5 (Alaggio R. et al. doi:10.1038/s41375-022-01620-2);
- Disease Assessment:
- Criteria for Relapsed/Refractory lymphoid neoplasms: Meeting any one of the following three conditions: ① Failure to achieve at least a partial response (PR) per Lugano criteria after two cycles of standard first-line therapy; ② Disease progression within six months after achieving a response to first-line therapy, or progression after six months with no response to the original first-line or second-line regimen; ③ Relapse after hematopoietic stem cell transplantation.
- Criteria for EBV Infection: Meeting any one of the following three conditions: ① Peripheral blood (plasma or whole blood) EBV DNA load ≥ 10³ copies/ml by quantitative PCR; ②Tumor cell GP350 positivity (≥10% of tumor cells by immunohistochemistry or flow cytometry); ③ Serological detection of EBV antibodies indicating any of the following: positive anti-VCA-IgM; positive anti-EA-IgG; or simultaneous positivity for anti-VCA-IgM, anti-VCA-IgG, and anti-EBNA-IgG.
- At least one evaluable lymphoma lesion according to Lugano criteria, or confirmed active lytic EBV infection.
- Performance Status: ECOG score 0-2 and expected survival ≥3 months;
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- Age: 18-70 years, regardless of sex;
- Hematologic Criteria:
- Absolute neutrophil count (ANC) ≥1.0×10⁹/L;
- Hemoglobin >60 g/L;
- CD3+ T-cell count >0.5×10⁹/L;
- Platelet count >30×10⁹/L;
- Organ Function:
- Creatinine clearance ≥60 mL/min;
- ALT/AST ≤2× upper limit of normal (ULN);
- Total bilirubin ≤2× ULN;
- Left ventricular ejection fraction (LVEF) ≥50%, no pericardial effusion, and no clinically significant ECG abnormalities;
- Minimal or no pleural/ascitic fluid;
- Oxygen saturation ≥95%;
- Contraception:
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception until the last follow-up;
- Male participants with fertile partners must agree to use effective contraception until the last follow-up;
- Informed Consent: Psychologically stable, capable of understanding the study's purpose and procedures, willing to participate voluntarily, and able to provide signed informed consent and comply with protocol requirements.
Who cannot join
- Active Infections: Presence of active hepatitis A, B, or C infection, or other uncontrolled severe active infections (excluding EBV infection);
- Immunosuppression:
- History of acquired immunodeficiency syndrome (AIDS);
- Chronic use of immunosuppressants (including corticosteroids at doses equivalent to >15 mg/day of prednisone) for other conditions;
- Cardiac Dysfunction:
- NYHA Class III or IV congestive heart failure;
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- Myocardial infarction or coronary artery bypass grafting within the past 6 months;
- Clinically significant ventricular arrhythmia or unexplained syncope;
- History of severe non-ischemic cardiomyopathy;
- Cardiac insufficiency (left ventricular ejection fraction <45%) within 8 weeks prior to apheresis;
- Pregnancy/Contraception:
- Pregnant or lactating women;
- Participants (male or female) unwilling to use contraception;
- Hepatic/Renal Impairment:
- AST/ALT >3× upper limit of normal (ULN);
- Total bilirubin >3× ULN;
- Creatinine clearance <60 mL/min;
- Allergies: History of severe hypersensitivity to any study drugs;
- Prior Stem Cell Transplant: Must have discontinued immunosuppressants for >6 weeks post-transplant with no signs of graft-versus-host disease (GVHD);
- Other Exclusionary Conditions: Any other condition deemed unsuitable by the investigator (e.g., coagulation disorders, hemolytic anemia, etc.).
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
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230031
Zhimin Zhai, MD, +86-0551-63869571, zzzm889@163.com
About this study
Official title: GP350 CAR-T Cells for Relapse/Refractory and Epstein-Barr Virus Infection Associated Lymphoid Neoplasms, an Open-label, Single-arm Clinical Trial
This is a Phase 1/Phase 2 open-label, single-arm clinical study of GP350 CAR-T for Relapse/Refractory and Epstein-Barr virus infection associated lymphoid neoplasms.
Each participant will undergo leukapheresis after enrolment, receive treatment of the conditioning chemotherapy, and an intravenous infusion of CAR-T cells.
Each participant will proceed through the following study procedures:
- Screening
- Enrollment/Leukapheresis
- Conditioning chemotherapy
- CAR T treatment
- Post-treatment assessment
- Long-term follow-up
- Conditions
- EBV Associated Lymphoid Neoplasms
- Being tested
- GP350 CAR-T
- Keywords
- LAHS, EBV, Lymphoma, Lymphoid neoplasms, CAR-T
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GP350 CAR-TBiological
Lymphodepletion chemotherapy with fludarabine (25 mg/m²/day) and cyclophosphamide (250 mg/m²/day) should be administered for 2-3 consecutive days, with the final dose completed 48 hours before infusion. Alternatively, investigators may individualize this regimen based on the subject's specific clinical circumstances.
The target dose of GP350 CAR-T cells is 1.0-5.0×10⁶ CAR-T cells per kilogram of body weight, administered via intravenous injection. (The actual infused dose is allowed to vary within ±20% from the target dose, depending on the as-released product yield)
Patients with less than partial response AND without > Grade 2 CRS or any ICANS may receive 1 to 2 additional infusion of GP350 CAR-T cells at the same dose.
| Study group | Role | What they receive |
|---|---|---|
| CAR-T Treatment | Experimental | Not described Receives: Biological: GP350 CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
The percentage of patients with complete response (CR) and partial response (PR) according to the RECIL 2017 criteria determined by the study investigators
Measured: Month 12 post CAR-T infusion
EBV DNA clearance rate
Defined as the proportion of patients achieving two consecutive negative tests in plasma or whole blood at least 7 days apart following treatment, relative to the total treated population
Measured: Month 12 post CAR-T infusion
Treatment Emergent Adverse Event (TEAE)
TEAE is defined as an adverse event that occurs or worsens after receiving the first dose of the trial drug
Measured: Within 3 months post-infusion
Secondary outcomes (2)
Progression-Free Survival (PFS)
PFS is defined as the time from the GP350 CAR-T infusion date to the date of disease progression
Measured: 1 yesr post CAR-T infusion
Overall Survival (OS)
OS is the time from date of GP350 CAR-T infusion to the date of death due to any reason
Measured: 1 yesr post CAR-T infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start10 Nov 2025
- Primary completion10 Nov 2030 (estimated)
- Study completion20 Nov 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EBV Associated Lymphoid NeoplasmsStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhimin Zhai
- Sponsor type
- University, hospital or other
- Collaborators
- Zeno Therapeutics Pte. Ltd
- Responsible party
- Sponsor-investigator, Zhimin Zhai, The Second Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07306156
- Sponsor's protocol ID
- TXB2025-001
- Acronym
- ANXIN-02
- Status last verified
- Dec 2025
- First submitted
- 11 Dec 2025
- Last updated
- 29 Dec 2025
- Results posted
- 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 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GP350 CAR-T Cells for Relapse/Refractory and Epstein-Barr Virus Infection Associated Lymphoid Neoplasms, an Open-label, Single-arm Clinical Trial
- ClinicalTrials.gov ID
- NCT07306156
- Acronym / sponsor ID
- ANXIN-02 / TXB2025-001
- Conditions
- EBV Associated Lymphoid Neoplasms
- Keywords
- LAHS, EBV, Lymphoma, Lymphoid neoplasms, CAR-T
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Zhimin ZhaiUniversity, hospital or other
- Collaborators
- Zeno Therapeutics Pte. Ltd
- Study start
- 10 Nov 2025 (actual)
- Primary completion
- 10 Nov 2030 (estimated)
- Study completion
- 20 Nov 2032 (estimated)
- First posted
- 29 Dec 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.
This is a Phase 1/Phase 2 open-label, single-arm clinical study of GP350 CAR-T for Relapse/Refractory and Epstein-Barr virus infection associated lymphoid neoplasms.
Each participant will undergo leukapheresis after enrolment, receive treatment of the conditioning chemotherapy, and an intravenous infusion of CAR-T cells.
Each participant will proceed through the following study procedures:
- Screening
- Enrollment/Leukapheresis
- Conditioning chemotherapy
- CAR T treatment
- Post-treatment assessment
- Long-term follow-up
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAR-T Treatment | Experimental | Biological: GP350 CAR-T |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Diagnosis: Confirmed diagnosis of lymphoid neoplasms according to WHO-HAEM5 (Alaggio R. et al. doi:10.1038/s41375-022-01620-2);
- Disease Assessment:
- Performance Status: ECOG score 0-2 and expected survival ≥3 months;
- Age: 18-70 years, regardless of sex;
- Hematologic Criteria:
Key exclusion criteria (20 listed)
- Active Infections: Presence of active hepatitis A, B, or C infection, or other uncontrolled severe active infections (excluding EBV infection);
- Immunosuppression:
- Cardiac Dysfunction:
- Pregnancy/Contraception:
- Hepatic/Renal Impairment:
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 |
|---|---|---|
| GP350 CAR-TLymphodepletion chemotherapy with fludarabine (25 mg/m²/day) and cyclophosphamide (250 mg/m²/day) should be administered for 2-3 consecutive days, with the final dose completed 48 hours before infusion. Alternatively, investigators may individualize this regimen based on the subject's specific clinical circumstances. The target dose of GP350 CAR-T cells is 1.0-5.0×10⁶ CAR-T cells per kilogram of body weight, administered via intravenous injection. (The actual infused dose is allowed to vary within ±20% from the target dose, depending on the as-released product yield) Patients with less than partial response AND without > Grade 2 CRS or any ICANS may receive 1 to 2 additional infusion of GP350 CAR-T cells at the same dose. | Biological | CAR-T Treatment |
Primary outcome
Overall Response Rate (ORR)
Time frame: Month 12 post CAR-T infusion
The percentage of patients with complete response (CR) and partial response (PR) according to the RECIL 2017 criteria determined by the study investigators
EBV DNA clearance rate
Time frame: Month 12 post CAR-T infusion
Defined as the proportion of patients achieving two consecutive negative tests in plasma or whole blood at least 7 days apart following treatment, relative to the total treated population
Treatment Emergent Adverse Event (TEAE)
Time frame: Within 3 months post-infusion
TEAE is defined as an adverse event that occurs or worsens after receiving the first dose of the trial drug
2 secondary outcomes
Progression-Free Survival (PFS)
Time frame: 1 yesr post CAR-T infusion
Overall Survival (OS)
Time frame: 1 yesr post CAR-T 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 29 Dec 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GP350 CAR-T in people with EBV Associated Lymphoid Neoplasms, run by Zhimin Zhai 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 23 inclusion and 20 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 29 Dec 2025. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Zhimin Zhai, MD (+86-0551-63869571, zzzm889@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) (time frame: Month 12 post CAR-T infusion). The study lists 3 primary outcomes in all. 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 29 Dec 2025.