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Nasopharyngeal CarcinomaEarly Phase 1NCT05654077

EBV CAR-T Cells for Nasopharyngeal Carcinoma

A Early Phase 1 study testing CAR-T 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 The sponsor has not verified this record for over two years, so it may be out of date.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

The aim of this study is to investigate the safety and preliminary efficacy of EBV CAR-T cells in the treatment of relapsed/refractory NPC 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?
CAR-T 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
24 participants
Where
1 siteChina
Study dates
18 Jan 2022to 30 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)Voluntarily sign written informed consent;
  • 2)Age ≥18, ≤75 years old, male and female;
  • 3 )Estimated survival ≥ 3 months;
  • 4) ECOG physical fitness score was 0-2;
  • 5) EBV positive nasopharyngeal carcinoma was diagnosed;
  • 6) Positive target detection;
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  • 7) At least one measurable lesion according to RECIST V1.1 solid tumor evaluation criteria;
  • 8) Patients with recurrent/metastatic nasopharyngeal carcinoma who had previously failed second-line or higher systemic therapy;
  • 9) Monopheresis or venous blood collection venous access can be established, and there are no other contraindications for blood cell separation;
  • 10) Full organ and bone marrow function,
  • 11) Toxicity and side effects left by previous anti-tumor therapy (radiotherapy, chemotherapy, targeted therapy, etc.) ≤ grade 1 (CTCAE 5.0);
  • 12) Fertile subjects (male or female) must use effective medical contraception during the study period and for 6 months after the end of administration. In female subjects of reproductive age, a negative pregnancy test should be performed within 72 h prior to the first dose.

Who cannot join

  • 1) There are active CNS metastases (except those stabilized by treatment);
  • 2)HIV positive, HBsAg positive, HBV DNA copy number positive (quantitative test ≥1000cps/ mL), HCV antibody positive and HCV RNA positive;
  • 3) Those with mental or psychological diseases who cannot cooperate with treatment and efficacy evaluation;
  • 4) subjects with severe autoimmune diseases and long-term use of immunosuppressants;
  • 5) Within 14 days prior to enrollment, there were active or uncontrollable infections requiring systemic treatment;
  • 6) Any unstable systemic disease
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  • 7) Complicated with lung, brain, kidney and other important organ dysfunction;
  • 8) Subjects have undergone major surgery or trauma in the 4 weeks prior to receiving cell therapy, or are expected to undergo major surgery during the study period;
  • 9) Subjects received their last radiotherapy or anti-tumor therapy (chemotherapy, targeted therapy, or immunotherapy) within 4 weeks prior to receiving cell therapy;
  • 10) The subject currently has or has had other malignancies that cannot be cured within 3 years, except cervical carcinoma in situ or basal cell carcinoma of the skin, and other malignancies with disease-free survival of more than 5 years;
  • 11) T cells modified with chimeric antigen receptor (CAR T, TCR-T) within six months;
  • 12) Combined graft versus host disease (GVHD);
  • 13) Subjects who were receiving systemic steroids prior to screening and determined by the investigator to require long-term systemic steroid use during treatment (other than inhalation or topical use); And subjects who were treated with systemic steroids (except for inhalation or topical use) within 72 h prior to cell infusion;
  • 14) A history of severe allergies or allergies;
  • 15) Subjects requiring anticoagulant therapy;
  • 16) Women who are pregnant or breast-feeding, or have a pregnancy plan within six months (for both men and women);
  • 17) Researchers believe that there are other reasons not to include patients 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: To Investigate the Safety and Preliminary Efficacy of EBV CAR-T Cells in the Treatment of Relapsed/Refractory EBV-positive Nasopharyngeal Carcinoma

The aim of this study is to investigate the safety and preliminary efficacy of EBV CAR-T cells in the treatment of relapsed/refractory NPC

Read the detailed description

The investigators designed a single-arm, open-label, "3+3" dose-escalation exploratory study. According to the subject and dose escalation test, the maximum dose or the best effective dose was determined to verify the safe and effective number of cells per body weight. A "3+3" dose escalation design was used to set three dose groups of gradually increasing CAR-T cells for therapeutic evaluation. The dose groups were 3.0×10^6cells/kg, 9.0×10^6cells/kg and 1.5×10^7cells/kg, respectively. Cell reinfusion will take place on day 0 (d0) and each subject will be observed for at least 4 weeks after receiving cell reinfusion (DLT observation period).

Being tested
CAR-T Cell Injection, Fludarabine, cyclophosphamide
Keywords
CAR-T, nasopharyngeal carcinoma, Recurrent/refractory 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.

  • CAR-T Cell InjectionBiological

    intravenously once, and the dose group was 3.0 × 10^6cells/kg、9.0 × 10^6cells/kg、1.5 × 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 NCT05654077
Study groupRoleWhat they receive
CAR-T Cell InjectionExperimentalA total of 24 patients with recurrent or refractory NPC received a single intravenous infusion of CAR-T cells at doses of 3.0 × 10^6cells/kg, 9.0 × 10^6cells/kg, and 1.5 × 10^7cells/kg, respectively, and were enrolled according to the conventional "3+3" dose escalation.
Receives: Biological: CAR-T 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 CAR-T cell injection , as specified in the protocol

    Measured: From day 0 to day 28

Secondary outcomes (6)

  1. Cmax

    The amplification of CAR-T cells in peripheral blood peaked after administration

    Measured: 12 months

  2. Tmax

    Number of days of peak CAR-T cell expansion after administration

    Measured: 12 months

  3. AUC(Day 0 to Day 28)

    The area under the curve of CAR-T cells from day 0 to day 28 after administration was plotted by the visit time of CAR-T cells in peripheral blood

    Measured: From day 0 to day 28

  4. ORR

    Proportion of patients who achieved pre-defined tumor volume change 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 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 posted16 Dec 2022
  2. Study start18 Jan 2022
  3. Primary completion30 Dec 2022 (estimated)
  4. Study completion30 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
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05654077
Sponsor's protocol ID
BR-EB-10
Status last verified
Dec 2022
First submitted
7 Dec 2022
Last updated
19 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 CAR-T 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 12 inclusion and 17 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 19 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 NCT05654077.

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 19 Dec 2022.

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