EBV CAR-T Cells for Nasopharyngeal Carcinoma

NCT05654077 | Unknown Early Phase 1

• 1 other identifier: BR-EB-10
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Nasopharyngeal Carcinoma

Keywords

CAR-T; nasopharyngeal carcinoma; Recurrent/refractory nasopharyngeal carcinoma

Outcome Measures

Primary Outcomes (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

  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)

CAR-T Cell Injection

EXPERIMENTAL

A 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.

Biological: CAR-T Cell Injection; Drug: Fludarabine; Drug: cyclophosphamide

Interventions

CAR-T Cell Injection BIOLOGICAL

intravenously once, and the dose group was 3.0 × 10\^6cells/kg、9.0 × 10\^6cells/kg、1.5 × 10\^7cells/kg。

CAR-T 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

CAR-T 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

CAR-T 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:

• )Voluntarily sign written informed consent;
• )Age ≥18, ≤75 years old, male and female;
• )Estimated survival ≥ 3 months;
• \) ECOG physical fitness score was 0-2;
• \) EBV positive nasopharyngeal carcinoma was diagnosed;
• \) Positive target detection;
• \) At least one measurable lesion according to RECIST V1.1 solid tumor evaluation criteria;
• \) Patients with recurrent/metastatic nasopharyngeal carcinoma who had previously failed second-line or higher systemic therapy;
• \) Monopheresis or venous blood collection venous access can be established, and there are no other contraindications for blood cell separation;
• \) Full organ and bone marrow function,
• \) Toxicity and side effects left by previous anti-tumor therapy (radiotherapy, chemotherapy, targeted therapy, etc.) ≤ grade 1 (CTCAE 5.0);
• \) 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.

You may not qualify if:

• \) There are active CNS metastases (except those stabilized by treatment);
• )HIV positive, HBsAg positive, HBV DNA copy number positive (quantitative test ≥1000cps/ mL), HCV antibody positive and HCV RNA positive;
• \) Those with mental or psychological diseases who cannot cooperate with treatment and efficacy evaluation;
• \) subjects with severe autoimmune diseases and long-term use of immunosuppressants;
• \) Within 14 days prior to enrollment, there were active or uncontrollable infections requiring systemic treatment;
• \) Any unstable systemic disease
• \) Complicated with lung, brain, kidney and other important organ dysfunction;
• \) 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;
• \) Subjects received their last radiotherapy or anti-tumor therapy (chemotherapy, targeted therapy, or immunotherapy) within 4 weeks prior to receiving cell therapy;
• \) 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;
• \) T cells modified with chimeric antigen receptor (CAR T, TCR-T) within six months;
• \) Combined graft versus host disease (GVHD);
• \) 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;
• \) A history of severe allergies or allergies;
• \) Subjects requiring anticoagulant therapy;

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

Immunotherapy, Adoptive; 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)

Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques; 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: December 7, 2022
• First Posted: December 16, 2022
• Study Start: January 18, 2022
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2025
• Last Updated: December 19, 2022

Record last verified: 2022-12

Locations

CN (1)