GB5005 CART-cell Injection in the Treatment of Patients With CD19-positive RR B-NHL

NCT06875063 | Recruiting Phase 1

• 1 other identifier: XMDYYYXYK-17
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and tolerability of GB5005 in patients with CD19-positive relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL).

Conditions

Refractory Lymphoma; Chimeric Antigen Receptor T-cell; Non-hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

• Complete remission (CR)

  Complete remission rate was determined on the basis of investigator assessments according to 2014 Lugano criteria.

  Up to 3 months

Secondary Outcomes (2)

• Recurrence free survival time (RFS)

  Up to 24 months

• Overall survival（OS）

  Up to 24 months

Study Arms (4)

Low dose group

EXPERIMENTAL

GB5005 chimeric antigen receptor T-cell injection（1 × 10 \^ 6 cells/kg）

Drug: GB5005 CART

Median dose group

EXPERIMENTAL

GB5005 chimeric antigen receptor T-cell injection（2 × 10 \^ 6 cells/kg）

Drug: GB5005 CART

Medium to high dose group

EXPERIMENTAL

GB5005 chimeric antigen receptor T-cell injection（3 × 10 \^ 6 cells/kg）

Drug: GB5005 CART

High dose group

EXPERIMENTAL

GB5005 chimeric antigen receptor T-cell injection（5 × 10 \^ 6 cells/kg）

Drug: GB5005 CART

Interventions

GB5005 CART DRUG

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.

Also known as: GB5005 chimeric antigen receptor T-cell injection

High dose group; Low dose group; Median dose group; Medium to high dose group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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;
• 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;
• ：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.

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University: lead

Study Sites (1)

Bing Xu

Xiamen, Fujian, 361000, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Bing Xu

  The First Aiffiliated hosptical of xiamen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bing Xu

CONTACT

18750918842; xubingzhangjian@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 8, 2025
• First Posted: March 13, 2025
• Study Start: April 30, 2026
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)