Clinical Study of the Safety and Initial Efficacy of BGT007 Cells in the Treatment of Patients With Relapsed /Metastatic Nasopharyngeal Carcinoma
Overview
- Phase
- Early Phase 1
- Intervention
- Fludarabine
- Conditions
- Nasopharyngeal Carcinoma
- Sponsor
- The Affiliated Hospital of Xuzhou Medical University
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Dose-limiting toxicity（DLT）
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
This is an exploratory study to evaluate the safety and preliminary effectiveness of BGT007 cells in the treatment of recurrent/metastatic nasopharyngeal carcinoma
Detailed Description
The researchers designed a single arm, open, exploratory study to improve the "3+3" dose escalation. The maximum dose or the best effective dose shall be determined according to the subject and dose increasing test to verify the safe and effective number of cells per unit weight. The improved "3+3" dose increasing design was adopted, and BGT007 cells were set with 5 dose groups that were gradually increased for treatment evaluation. The dose groups were 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。 Cell reinfusion will be carried out on day 0 (d0), and each subject will be observed for at least 4 weeks after receiving cell reinfusion (DLT observation period)
Investigators
Eligibility Criteria
Inclusion Criteria
- •Sign the written informed consent voluntarily;
- •Age ≥ 18, ≤ 75, male or female;
- •3.Expected life ≥ 3 months
- •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
- •According to RECIST v1.1 solid tumor evaluation criteria, there is at least one measurable lesion;
- •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);
- •It is possible to establish a single blood collection or venous blood collection channel, and there is no other blood cell separation contraindication;
- •It has sufficient organ and bone marrow functions, as defined below
- •routine blood test
Exclusion Criteria
- •Active central nervous system metastasis (except those that are stable after treatment);
- •HIV positive or HBsAg positive, HBV DNA copy number is positive (quantitative test ≥ 1000 cps/ml) or HCV antibody is positive and HCV RNA is positive;
- •Those who have mental or psychological diseases and cannot cooperate with the treatment and efficacy evaluation;
- •Subjects with severe autoimmune diseases and long-term application of immunosuppressants;
- •There is active infection or uncontrollable infection requiring systemic treatment within 14 days before signing the informed consent form;
- •Any unstable systemic disease (including but not limited to): Active infection (except local infection);
- •Unstable angina pectoris;
- •Cerebrovascular ischemia or cerebrovascular accident (within 6 months before screening);
- •Myocardial infarction (within 6 months before screening);
- •Congestive heart failure (New York Heart Association \[HYHA\] classification ≥ Ⅲ);
Arms & Interventions
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.
Intervention: Fludarabine
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.
Intervention: BGT007 Cell Injection
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.
Intervention: cyclophosphamide
Outcomes
Primary Outcomes
Dose-limiting toxicity（DLT）
Time Frame: From day 0 to day 28
Adverse events related to cell therapy were observed on 28 days after BGT007 cell injection , as specified in the protocol
Secondary Outcomes
- Tmax(12 months)
- AUC(Day 0 to Day 28)(From day 0 to day 28)
- ORR(12 months)
- PFS(12 months)
- OS(12 months)
- Cmax(12 months)