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CAR T-cell Therapy

TGF-beta Resistant Cytotoxic T-lymphocytes for Nasopharyngeal Cancer

Phase 1
Waitlist Available
Led By Helen Heslop, MD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The patient must meet the following eligibility criteria to be included for TREATMENT: Nasopharyngeal Carcinoma in first or subsequent relapse or with primary refractory disease, EBV positive tumor, Patients with life expectancy greater than or equal to 6 weeks, Bilirubin less than or equal to 3x upper limit of normal, AST less than or equal to 5x upper limit of normal, ANC>750/microliter, Platelets > 50,000/microliter, Hgb ≥ 7.0g/dl (can be transfused), Creatinine less than or equal to 2x upper limit of normal for age, Creatinine clearance (as estimated by Cockcroft Gault or Schwartz) greater than or equal to 60 ml/min, Pulse oximetry of > 90% on room air, Off investigational therapy for 4 weeks prior to study entry, Karnofsky or Lansky score of greater than or equal to 50%, Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded. The male partner should use a condom, Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.
The patient must meet the following eligibility inclusion criteria at the time of PROCUREMENT: Nasopharyngeal Carcinoma in first or subsequent relapse or with primary refractory disease, EBV positive tumor, Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent
Must not have
At time of Treatment: Pregnant or lactating, Severe intercurrent infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is a Phase I study which will test the safety of the DNR.NPC-specific T cells. The study will also help us to understand how well the cells work in patients.

Who is the study for?
This trial is for people with nasopharyngeal carcinoma, a type of cancer linked to the Epstein-Barr virus. Participants must have a certain level of white blood cells, kidney function within specific limits, and not be pregnant or HIV positive. They should expect to live at least six weeks and agree to use effective birth control during and after the study.
What is being tested?
The trial tests genetically modified T cells designed to fight cancer by targeting EBV-infected cells in patients with nasopharyngeal carcinoma. Some participants will receive these T cells alone, while others will also get chemotherapy drugs cyclophosphamide and fludarabine beforehand to potentially enhance results.
What are the potential side effects?
Possible side effects include reactions related to immune cell infusion such as fever or chills, fatigue from chemotherapy, lowered blood counts increasing infection risk, nausea, and potential organ inflammation due to an enhanced immune response.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have nasopharyngeal carcinoma that has returned or didn't respond to treatment, and it's EBV positive. I've signed the informed consent.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not pregnant, breastfeeding, or have a severe infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of subjects with a dose limiting toxicity
Secondary study objectives
Amount of T cells in the blood after the infusions
Other study objectives
Number of patients with a response to the T cells

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: DNR.NPC-specific T cells or DNR.NPC-specific T cells + c/fExperimental Treatment2 Interventions
DNR.NPC-specific T cells or DNR.NPC-specific T cells + c/f

Find a Location

Who is running the clinical trial?

The Methodist Hospital Research InstituteOTHER
285 Previous Clinical Trials
81,672 Total Patients Enrolled
7 Trials studying Nasopharyngeal Carcinoma
159 Patients Enrolled for Nasopharyngeal Carcinoma
Baylor College of MedicineLead Sponsor
1,024 Previous Clinical Trials
6,029,496 Total Patients Enrolled
7 Trials studying Nasopharyngeal Carcinoma
159 Patients Enrolled for Nasopharyngeal Carcinoma
Center for Cell and Gene Therapy, Baylor College of MedicineOTHER
112 Previous Clinical Trials
2,841 Total Patients Enrolled
7 Trials studying Nasopharyngeal Carcinoma
159 Patients Enrolled for Nasopharyngeal Carcinoma

Media Library

DNR.NPC-specific T cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02065362 — Phase 1
~1 spots leftby Nov 2025
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