Early Phase 1 Head and Neck Cancer Trial, Recruiting NCT05587543 Sponsor: Fudan University Condition: Head and Neck Cancer
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Early Phase 1 Head and Neck Cancer Trial, Recruiting

NCT05587543
Recruiting Early Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are willing and able to give written consent to participate
  • Adults aged 18 to 75 years old (any gender)
  • People with an expected survival of at least 3 months
  • People with a general health and activity level rated between 0 and 2 on a standard oncology scale (meaning able to carry out at least some daily activities)
  • People who have been diagnosed with EBV-positive nasopharyngeal carcinoma (a type of throat/head cancer linked to the Epstein-Barr virus), confirmed by a specific laboratory test on tissue samples taken within the past 5 years
  • People who have at least one tumour that can be measured using standard imaging criteria
  • People whose nasopharyngeal carcinoma has come back or spread, and whose cancer has not responded to at least two previous rounds of treatment
  • People for whom a blood collection procedure (apheresis) can be safely carried out
  • People whose side effects from previous cancer treatments have largely resolved to a minimal level (below grade 1 on a standard side-effect scale)
  • People of childbearing potential (male or female) who are willing to use effective contraception during the study and for 6 months after treatment ends; women of childbearing age must also have a negative pregnancy test within 72 hours before the first dose

Who may not be able to join:

  • People with active cancer that has spread to the brain or central nervous system, unless it has been treated and is considered stable
  • People who test positive for HIV, active Hepatitis B (with detectable virus levels above a certain threshold), or active Hepatitis C
  • People with mental health or psychological conditions that would make it difficult to participate in or be assessed during the trial
  • People with a serious autoimmune disease who require long-term use of immune-suppressing medications
  • People who have had an active or uncontrolled infection requiring treatment throughout the body within the 14 days before joining the trial
  • People with any unstable ongoing illness affecting the whole body
  • People with significant problems with important organs such as the lungs, brain, or kidneys
  • People who have had major surgery or a serious physical injury within 4 weeks before the cell therapy, or who are expected to need major surgery during the trial
  • People who received their last dose of radiation or other anti-cancer treatment within 4 weeks before the cell therapy
  • People who have had, or currently have, another cancer that was not curable within the past 3 years — with exceptions for certain early-stage or fully resolved cancers (confirm with trial site)
  • People who have received CAR-T cell therapy (a type of immune cell therapy) within the past 6 months
  • People who have graft-versus-host disease (a condition that can occur after certain transplant procedures)
  • People who are currently on ongoing systemic steroid medication (taken by mouth or injection, not inhaled or applied to skin), or who are expected to need long-term systemic steroids during the trial; also people who received systemic steroids within 72 hours before the cell infusion
  • People with a history of severe allergic reactions
  • People who require blood-thinning (anticoagulant) medication
  • Women who are pregnant or breastfeeding, or anyone (male or female) planning to conceive within 6 months
  • People the trial investigators consider unsuitable for other reasons (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Early Phase 1 studies are small, early exploratory studies that come before the main Phase 1 to 3 testing, so a standard phase success rate does not apply.

Contact this trial

Principal Investigator: Dongmei Ji, Doctorate, Fudan University

Phone: 13564183928

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Early Phase 1
Registry
ClinicalTrials.gov
Start date
28 December 2022
Est. completion
1 October 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Dose Limiting Toxicities; MTD or the best effective dose; Incidence of AE、SAE、AESI

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov