search
Back to results

BGT007 Cell Treatment of Nasopharyngeal Carcinoma

Primary Purpose

Nasopharyngeal Carcinoma

Status
Recruiting
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
BGT007 Cell Injection
Fludarabine
cyclophosphamide
Sponsored by
The Affiliated Hospital of Xuzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring CAR-T, nasopharyngeal carcinoma, recurrent/metastatic nasopharyngeal carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 1. Active central nervous system metastasis (except those that are stable after treatment); 2. 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; 3. Those who have mental or psychological diseases and cannot cooperate with the treatment and efficacy evaluation; 4. Subjects with severe autoimmune diseases and long-term application of immunosuppressants; 5. There is active infection or uncontrollable infection requiring systemic treatment within 14 days before signing the informed consent form; 6. 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); Serious arrhythmia requiring drug treatment; Heart disease needs treatment or hypertension is out of control after treatment (blood pressure>160mmHg/100mmHg); 7. Complicated with dysfunction of lung, brain, kidney and other important organs; 8. Subjects had undergone major surgery or severe trauma within 4 weeks before signing the informed consent form, or were expected to undergo major surgery during the study period. 9. Subjects received the last radiotherapy or anti-tumor treatment (chemotherapy, targeted therapy or immunotherapy) within 4 weeks before signing the informed consent form; 10. The subject currently suffers from or has suffered from other malignant tumors that cannot be cured within 3 years, except for cervical cancer or skin basal cell cancer, and other malignant tumors with a disease-free survival period of more than 5 years; 11. Have received T cells (including CAR-T and TCR-T) modified by chimeric antigen receptor within half a year before signing the informed consent form; 12. Graft versus host disease (GVHD) 13. Subjects who were receiving systemic steroid treatment before signing the informed consent form and who were judged by the investigator to need long-term use of systemic steroid treatment during the treatment period (except for inhalation or local use); And subjects treated with systemic steroids within 72 hours before cell reinfusion (except for inhalation or local use); 14. Serious allergy or allergy history 15. Subjects requiring anticoagulation treatment 16. Pregnant or lactating women, or have a pregnancy plan within six months (for both men and women); 17. The investigator believes that there are other reasons that cannot be included in the treatment

Sites / Locations

  • The Affiliated Hospital of Xuzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BGT007 Cell Injection

Arm Description

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.

Outcomes

Primary Outcome Measures

Dose-limiting toxicity(DLT)
Adverse events related to cell therapy were observed on 28 days after BGT007 cell injection , as specified in the protocol

Secondary Outcome Measures

Cmax
The amplification of BGT007 cells in peripheral blood peaked after administration
Tmax
Number of days of peak BGT007 cell expansion after administration
AUC(Day 0 to Day 28)
The area under the curve of BGT007 cells from day 0 to day 28 after administration was plotted by the visit time of BGT007 cells in peripheral blood
ORR
Proportion of patients who achieved pre-defined tumor volume reduction and maintained the minimum time limit.Imaging examination was performed after administration, and RECIST1.1 evaluation criteria was used for evaluation
PFS
The time from the onset of leukocyte apheresis to the appearance of tumor progression or death.
OS
The time between leukocyte apheresis and death from any cause.

Full Information

First Posted
October 30, 2022
Last Updated
December 14, 2022
Sponsor
The Affiliated Hospital of Xuzhou Medical University
Collaborators
Guangzhou Bioresette Biomedical Technology Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT05616468
Brief Title
BGT007 Cell Treatment of Nasopharyngeal Carcinoma
Official Title
Clinical Study of the Safety and Initial Efficacy of BGT007 Cells in the Treatment of Patients With Relapsed /Metastatic Nasopharyngeal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 30, 2022 (Anticipated)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Affiliated Hospital of Xuzhou Medical University
Collaborators
Guangzhou Bioresette Biomedical Technology Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma
Keywords
CAR-T, nasopharyngeal carcinoma, recurrent/metastatic nasopharyngeal carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BGT007 Cell Injection
Arm Type
Experimental
Arm Description
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 Type
Biological
Intervention Name(s)
BGT007 Cell Injection
Intervention Description
BGT007 cells (d0) were infused intravenously once, and the dose group was 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。
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Other Intervention Name(s)
FLUDARA
Intervention Description
Fludarabine 25~30mg/m2/d was infused intravenously for 3 consecutive days. (- 5 days to - 3 days)
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Other Intervention Name(s)
Cytoxan
Intervention Description
250~350mg/m2/d cyclophosphamide was infused intravenously for 3 consecutive days. (- 5 days to - 3 days)
Primary Outcome Measure Information:
Title
Dose-limiting toxicity(DLT)
Description
Adverse events related to cell therapy were observed on 28 days after BGT007 cell injection , as specified in the protocol
Time Frame
From day 0 to day 28
Secondary Outcome Measure Information:
Title
Cmax
Description
The amplification of BGT007 cells in peripheral blood peaked after administration
Time Frame
12 months
Title
Tmax
Description
Number of days of peak BGT007 cell expansion after administration
Time Frame
12 months
Title
AUC(Day 0 to Day 28)
Description
The area under the curve of BGT007 cells from day 0 to day 28 after administration was plotted by the visit time of BGT007 cells in peripheral blood
Time Frame
From day 0 to day 28
Title
ORR
Description
Proportion of patients who achieved pre-defined tumor volume reduction and maintained the minimum time limit.Imaging examination was performed after administration, and RECIST1.1 evaluation criteria was used for evaluation
Time Frame
12 months
Title
PFS
Description
The time from the onset of leukocyte apheresis to the appearance of tumor progression or death.
Time Frame
12 months
Title
OS
Description
The time between leukocyte apheresis and death from any cause.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 1. Active central nervous system metastasis (except those that are stable after treatment); 2. 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; 3. Those who have mental or psychological diseases and cannot cooperate with the treatment and efficacy evaluation; 4. Subjects with severe autoimmune diseases and long-term application of immunosuppressants; 5. There is active infection or uncontrollable infection requiring systemic treatment within 14 days before signing the informed consent form; 6. 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); Serious arrhythmia requiring drug treatment; Heart disease needs treatment or hypertension is out of control after treatment (blood pressure>160mmHg/100mmHg); 7. Complicated with dysfunction of lung, brain, kidney and other important organs; 8. Subjects had undergone major surgery or severe trauma within 4 weeks before signing the informed consent form, or were expected to undergo major surgery during the study period. 9. Subjects received the last radiotherapy or anti-tumor treatment (chemotherapy, targeted therapy or immunotherapy) within 4 weeks before signing the informed consent form; 10. The subject currently suffers from or has suffered from other malignant tumors that cannot be cured within 3 years, except for cervical cancer or skin basal cell cancer, and other malignant tumors with a disease-free survival period of more than 5 years; 11. Have received T cells (including CAR-T and TCR-T) modified by chimeric antigen receptor within half a year before signing the informed consent form; 12. Graft versus host disease (GVHD) 13. Subjects who were receiving systemic steroid treatment before signing the informed consent form and who were judged by the investigator to need long-term use of systemic steroid treatment during the treatment period (except for inhalation or local use); And subjects treated with systemic steroids within 72 hours before cell reinfusion (except for inhalation or local use); 14. Serious allergy or allergy history 15. Subjects requiring anticoagulation treatment 16. Pregnant or lactating women, or have a pregnancy plan within six months (for both men and women); 17. The investigator believes that there are other reasons that cannot be included in the treatment
Facility Information:
Facility Name
The Affiliated Hospital of Xuzhou Medical University
City
Xuzhou
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang Wu
Phone
+86-516-83355832
Email
claude134134@126.com
First Name & Middle Initial & Last Name & Degree
Liantao Li
Phone
+86-516-83355832
Email
liliantao@xzhmu.edu.cn

12. IPD Sharing Statement

Learn more about this trial

BGT007 Cell Treatment of Nasopharyngeal Carcinoma

We'll reach out to this number within 24 hrs