BGT007 Cell Treatment of Nasopharyngeal Carcinoma

NCT05616468 | Unknown Early Phase 1

• 1 other identifier: BR-BGT-001
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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

Conditions

Nasopharyngeal Carcinoma

Keywords

CAR-T; nasopharyngeal carcinoma; recurrent/metastatic nasopharyngeal carcinoma

Outcome Measures

Primary Outcomes (1)

• Dose-limiting toxicity（DLT）

  Adverse events related to cell therapy were observed on 28 days after BGT007 cell injection , as specified in the protocol

  From day 0 to day 28

Secondary Outcomes (6)

• Cmax

  12 months

• Tmax

  12 months

• AUC(Day 0 to Day 28)

  From day 0 to day 28

• ORR

  12 months

• PFS

  12 months

Study Arms (1)

BGT007 Cell Injection

EXPERIMENTAL

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.

Biological: BGT007 Cell Injection; Drug: Fludarabine; Drug: cyclophosphamide

Interventions

BGT007 Cell Injection BIOLOGICAL

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。

BGT007 Cell Injection

Fludarabine DRUG

Fludarabine 25\~30mg/m2/d was infused intravenously for 3 consecutive days. (- 5 days to - 3 days)

Also known as: FLUDARA

BGT007 Cell Injection

cyclophosphamide DRUG

250\~350mg/m2/d cyclophosphamide was infused intravenously for 3 consecutive days. (- 5 days to - 3 days)

Also known as: Cytoxan

BGT007 Cell Injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Sign the written informed consent voluntarily;
• \. Age ≥ 18, ≤ 75, male or female;
• Expected life ≥ 3 months
• \. The physical condition score of the Eastern Tumor Cooperative Organization (ECOG) is 0-2;
• 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
• 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)

You may not qualify if:

• \. 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);
• Serious arrhythmia requiring drug treatment;
• Heart disease needs treatment or hypertension is out of control after treatment (blood pressure\>160mmHg/100mmHg);
• \. Complicated with dysfunction of lung, brain, kidney and other important organs;
• \. 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.
• \. Subjects received the last radiotherapy or anti-tumor treatment (chemotherapy, targeted therapy or immunotherapy) within 4 weeks before signing the informed consent form;

Sponsors & Collaborators

• The Affiliated Hospital of Xuzhou Medical University: lead
• Guangzhou Bioresette Biomedical Technology Co., Ltd.: collaborator

Study Sites (1)

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

fludarabine; fludarabine phosphate; Cyclophosphamide

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2022
• First Posted: November 15, 2022
• Study Start: December 30, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 31, 2025
• Last Updated: December 15, 2022

Record last verified: 2022-12

Locations

CN (1)