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Trial Title:
BGT007 Cell Treatment of Nasopharyngeal Carcinoma
NCT ID:
NCT05616468
Condition:
Nasopharyngeal Carcinoma
Conditions: Official terms:
Carcinoma
Nasopharyngeal Carcinoma
Cyclophosphamide
Fludarabine
Conditions: Keywords:
CAR-T
nasopharyngeal carcinoma
recurrent/metastatic nasopharyngeal carcinoma
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
BGT007 Cell Injection
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。
Arm group label:
BGT007 Cell Injection
Intervention type:
Drug
Intervention name:
Fludarabine
Description:
Fludarabine 25~30mg/m2/d was infused intravenously for 3 consecutive days. (- 5 days to -
3 days)
Arm group label:
BGT007 Cell Injection
Other name:
FLUDARA
Intervention type:
Drug
Intervention name:
cyclophosphamide
Description:
250~350mg/m2/d cyclophosphamide was infused intravenously for 3 consecutive days. (- 5
days to - 3 days)
Arm group label:
BGT007 Cell Injection
Other name:
Cytoxan
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)
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Affiliated Hospital of Xuzhou Medical University
Address:
City:
Xuzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Yang Wu
Phone:
+86-516-83355832
Email:
claude134134@126.com
Contact backup:
Last name:
Liantao Li
Phone:
+86-516-83355832
Email:
liliantao@xzhmu.edu.cn
Start date:
December 30, 2022
Completion date:
December 31, 2025
Lead sponsor:
Agency:
The Affiliated Hospital of Xuzhou Medical University
Agency class:
Other
Collaborator:
Agency:
Guangzhou Bioresette Biomedical Technology Co., Ltd.
Agency class:
Other
Source:
The Affiliated Hospital of Xuzhou Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05616468
