Clinical Study of the Safety and Initial Efficacy of BGT007 Cells in the Treatment of Patients With Relapsed /Metastatic Nasopharyngeal Carcinoma

Status: Recruiting
Location: See location...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

This is an exploratory study to evaluate the safety and preliminary effectiveness of BGT007 cells in the treatment of recurrent/metastatic nasopharyngeal carcinoma

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• 1\. Sign the written informed consent voluntarily;

• 2\. Age ≥ 18, ≤ 75, male or female;

• 3.Expected life ≥ 3 months

• 4\. The physical condition score of the Eastern Tumor Cooperative Organization (ECOG) is 0-2;

• 5.Biopsy sample or pathological wax slice test (within 1 year before signing the informed consent): target test positive

• 6\. According to RECIST v1.1 solid tumor evaluation criteria, there is at least one measurable lesion;

• 7\. Patients with recurrent/metastatic nasopharyngeal carcinoma who have received second-line or above system treatment failure in the past (Recurrence of nasopharyngeal carcinoma: nasopharyngeal carcinoma confirmed by pathology, after radical radiotherapy, the clinical tumor disappears completely, and after 6 months of treatment, local tumors with the same pathological type as the original tumor reappear; metastasis of nasopharyngeal carcinoma: tumor cells transfer from the primary site to distant organs through various ways, such as blood and lymph, and form tumor metastasis focus);

• 8\. It is possible to establish a single blood collection or venous blood collection channel, and there is no other blood cell separation contraindication;

• 9\. It has sufficient organ and bone marrow functions, as defined below

⁃ routine blood test

⁃ Neutrophil count (NEUT #) ≥ 1.0 × 10\^9/L

⁃ Platelet count (PLT) ≥ 80 × 10\^9/L

⁃ Hemoglobin concentration ≥ 90g/L

⁃ Liver function: subjects without liver metastasis

⁃ Aspartate aminotransferase (AST) ≤ 2.5 × Upper limit of normal value (ULN)

⁃ Alanine aminotransferase (ALT) ≤ 2.5 × Upper limit of normal value (ULN)

⁃ Total bilirubin (TBIL) ≤ 1.5 × ULN

⁃ Liver function: subjects with liver metastasis

⁃ Aspartate aminotransferase (AST) ≤ 5 × Upper limit of normal value (ULN)

⁃ Alanine aminotransferase (ALT) ≤ 5 × Upper limit of normal value (ULN)

⁃ Liver function: subjects with liver metastasis or Gilbert syndrome

⁃ Total bilirubin (TBIL) ≤ 2 × ULN

⁃ renal function

⁃ Creatinine clearance rate (CCR) ≥ 50mL/min

⁃ Coagulation function

⁃ International normalized ratio (INR) ≤ 1.5 × ULN

⁃ Activated partial thromboplastin event (APTT) ≤ 1.5 × ULN

• 10\. Toxic side effects left by early anti-tumor therapy (radiotherapy, chemotherapy, targeted therapy, etc.) ≤ Level 1 (CTCAE5.0);

• 11\. During the study period and within 6 months after the last administration, subjects with fertility (male or female) must take effective medical contraceptive measures. Female subjects of childbearing age must have a pregnancy test within 72 hours before the first administration, and the result is negative.

Locations
Other Locations
China
The Affiliated Hospital of Xuzhou Medical University
RECRUITING
Xuzhou
Time Frame
Start Date: 2022-12-30
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 23
Treatments
Experimental: BGT007 Cell Injection
In this study, 23 patients diagnosed with recurrent/metastatic nasopharyngeal carcinoma will receive a single intravenous infusion of BGT007 cells after enrollment, with a dose of 5.0 × 10\^5cells/kg,1.0 × 10\^6cells/kg,3.0 × 10\^6cells/kg,6.0 × 10\^6cells/kg,1.0 × 10\^7cells/kg。 One subject was enrolled in each of the first two dose groups, and the other three dose groups were enrolled in accordance with the conventional 3+3 dose increase.
Related Therapeutic Areas
Sponsors
Collaborators: Guangzhou Bioresette Biomedical Technology Co., Ltd.
Leads: The Affiliated Hospital of Xuzhou Medical University

This content was sourced from clinicaltrials.gov