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Nasopharyngeal CarcinomaEarly Phase 1NCT05616468

BGT007 Cell Treatment of Nasopharyngeal Carcinoma

A Early Phase 1 study testing BGT007 Cell Injection, Fludarabine and cyclophosphamide in people with Nasopharyngeal Carcinoma, run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Nasopharyngeal Carcinoma
What is being tested?
BGT007 Cell Injection, Fludarabine and cyclophosphamide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
1 siteChina
Study dates
30 Dec 2022to 31 Dec 2025
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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);
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  • 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

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu

    Yang Wu, +86-516-83355832, claude134134@126.com

    Liantao Li, +86-516-83355832, liliantao@xzhmu.edu.cn

    Recruiting

Other trials in China

About this study

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

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

Read the 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)

Being tested
BGT007 Cell Injection, Fludarabine, cyclophosphamide
Keywords
CAR-T, nasopharyngeal carcinoma, recurrent/metastatic nasopharyngeal carcinoma
Medical subject headings
Nasopharyngeal Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BGT007 Cell InjectionBiological

    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。

  • FludarabineDrug

    Also called FLUDARA

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

  • cyclophosphamideDrug

    Also called Cytoxan

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

Study groups in NCT05616468
Study groupRoleWhat they receive
BGT007 Cell InjectionExperimentalIn 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.
Receives: Biological: BGT007 Cell Injection; Drug: Fludarabine; Drug: cyclophosphamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: From day 0 to day 28

Secondary outcomes (6)

  1. Cmax

    The amplification of BGT007 cells in peripheral blood peaked after administration

    Measured: 12 months

  2. Tmax

    Number of days of peak BGT007 cell expansion after administration

    Measured: 12 months

  3. 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

    Measured: From day 0 to day 28

  4. 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

    Measured: 12 months

  5. PFS

    The time from the onset of leukocyte apheresis to the appearance of tumor progression or death.

    Measured: 12 months

  6. OS

    The time between leukocyte apheresis and death from any cause.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2022
  2. Study start30 Dec 2022 (estimated)
  3. Primary completion1 Dec 2024 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
23 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05616468
Sponsor's protocol ID
BR-BGT-001
Status last verified
Dec 2022
First submitted
30 Oct 2022
Last updated
15 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing BGT007 Cell Injection, Fludarabine and cyclophosphamide in people with Nasopharyngeal Carcinoma, run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 29 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicity（DLT） (time frame: From day 0 to day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05616468.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2022.

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