Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 8:37 AM
Study NCT ID:
NCT07306156
Status:
RECRUITING
Last Update Posted:
2025-12-29
First Post:
2025-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GP350 CAR-T for Relapse/Refractory and Epstein-Barr Virus Infection Associated Lymphoid Neoplasms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2032-11-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-24', 'studyFirstSubmitDate': '2025-12-11', 'studyFirstSubmitQcDate': '2025-12-24', 'lastUpdatePostDateStruct': {'date': '2025-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-11-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Response Rate (ORR)', 'timeFrame': 'Month 12 post CAR-T infusion', 'description': 'The percentage of patients with complete response (CR) and partial response (PR) according to the RECIL 2017 criteria determined by the study investigators'}, {'measure': 'EBV DNA clearance rate', 'timeFrame': 'Month 12 post CAR-T infusion', 'description': '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'}, {'measure': 'Treatment Emergent Adverse Event (TEAE)', 'timeFrame': 'Within 3 months post-infusion', 'description': 'TEAE is defined as an adverse event that occurs or worsens after receiving the first dose of the trial drug'}], 'secondaryOutcomes': [{'measure': 'Progression-Free Survival (PFS)', 'timeFrame': '1 yesr post CAR-T infusion', 'description': 'PFS is defined as the time from the GP350 CAR-T infusion date to the date of disease progression'}, {'measure': 'Overall Survival (OS)', 'timeFrame': '1 yesr post CAR-T infusion', 'description': 'OS is the time from date of GP350 CAR-T infusion to the date of death due to any reason'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['LAHS', 'EBV', 'Lymphoma', 'Lymphoid neoplasms', 'CAR-T'], 'conditions': ['EBV Associated Lymphoid Neoplasms']}, 'descriptionModule': {'briefSummary': '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.\n\nEach participant will undergo leukapheresis after enrolment, receive treatment of the conditioning chemotherapy, and an intravenous infusion of CAR-T cells.\n\nEach participant will proceed through the following study procedures:\n\n* Screening\n* Enrollment/Leukapheresis\n* Conditioning chemotherapy\n* CAR T treatment\n* Post-treatment assessment\n* Long-term follow-up'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Diagnosis: Confirmed diagnosis of lymphoid neoplasms according to WHO-HAEM5 (Alaggio R. et al. doi:10.1038/s41375-022-01620-2);\n2. Disease Assessment:\n\n 1. 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.\n 2. 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.\n 3. At least one evaluable lymphoma lesion according to Lugano criteria, or confirmed active lytic EBV infection.\n3. Performance Status: ECOG score 0-2 and expected survival ≥3 months;\n4. Age: 18-70 years, regardless of sex;\n5. Hematologic Criteria:\n\n * Absolute neutrophil count (ANC) ≥1.0×10⁹/L;\n * Hemoglobin \\>60 g/L;\n * CD3+ T-cell count \\>0.5×10⁹/L;\n * Platelet count \\>30×10⁹/L;\n6. Organ Function:\n\n * Creatinine clearance ≥60 mL/min;\n * ALT/AST ≤2× upper limit of normal (ULN);\n * Total bilirubin ≤2× ULN;\n * Left ventricular ejection fraction (LVEF) ≥50%, no pericardial effusion, and no clinically significant ECG abnormalities;\n * Minimal or no pleural/ascitic fluid;\n * Oxygen saturation ≥95%;\n7. Contraception:\n\n * Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception until the last follow-up;\n * Male participants with fertile partners must agree to use effective contraception until the last follow-up;\n8. 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.\n\nExclusion Criteria:\n\n1. Active Infections: Presence of active hepatitis A, B, or C infection, or other uncontrolled severe active infections (excluding EBV infection);\n2. Immunosuppression:\n\n * History of acquired immunodeficiency syndrome (AIDS);\n * Chronic use of immunosuppressants (including corticosteroids at doses equivalent to \\>15 mg/day of prednisone) for other conditions;\n3. Cardiac Dysfunction:\n\n 1. NYHA Class III or IV congestive heart failure;\n 2. Myocardial infarction or coronary artery bypass grafting within the past 6 months;\n 3. Clinically significant ventricular arrhythmia or unexplained syncope;\n 4. History of severe non-ischemic cardiomyopathy;\n 5. Cardiac insufficiency (left ventricular ejection fraction \\<45%) within 8 weeks prior to apheresis;\n4. Pregnancy/Contraception:\n\n * Pregnant or lactating women;\n * Participants (male or female) unwilling to use contraception;\n5. Hepatic/Renal Impairment:\n\n * AST/ALT \\>3× upper limit of normal (ULN);\n * Total bilirubin \\>3× ULN;\n * Creatinine clearance \\<60 mL/min;\n6. Allergies: History of severe hypersensitivity to any study drugs;\n7. Prior Stem Cell Transplant: Must have discontinued immunosuppressants for \\>6 weeks post-transplant with no signs of graft-versus-host disease (GVHD);\n8. Other Exclusionary Conditions: Any other condition deemed unsuitable by the investigator (e.g., coagulation disorders, hemolytic anemia, etc.)."}, 'identificationModule': {'nctId': 'NCT07306156', 'acronym': 'ANXIN-02', 'briefTitle': 'GP350 CAR-T for Relapse/Refractory and Epstein-Barr Virus Infection Associated Lymphoid Neoplasms', 'organization': {'class': 'OTHER', 'fullName': 'The Second Hospital of Anhui Medical University'}, 'officialTitle': 'GP350 CAR-T Cells for Relapse/Refractory and Epstein-Barr Virus Infection Associated Lymphoid Neoplasms, an Open-label, Single-arm Clinical Trial', 'orgStudyIdInfo': {'id': 'TXB2025-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CAR-T Treatment', 'interventionNames': ['Biological: GP350 CAR-T']}], 'interventions': [{'name': 'GP350 CAR-T', 'type': 'BIOLOGICAL', 'description': "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.\n\nThe 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)\n\nPatients 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.", 'armGroupLabels': ['CAR-T Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '230031', 'city': 'Hefei', 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhimin Zhai, MD', 'role': 'CONTACT', 'email': 'zzzm889@163.com', 'phone': '+86-0551-63869571'}], 'facility': 'The Second Affiliated Hospital of Anhui Medical University', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}], 'centralContacts': [{'name': 'Zhimin Zhai, MD', 'role': 'CONTACT', 'email': 'zzzm889@163.com', 'phone': '+86-0551-63869571'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhimin Zhai', 'class': 'OTHER'}, 'collaborators': [{'name': 'Zeno Therapeutics Pte. Ltd', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chief of Hematology Department', 'investigatorFullName': 'Zhimin Zhai', 'investigatorAffiliation': 'The Second Hospital of Anhui Medical University'}}}}