About the RTX‑321 Clinical Trial

Participating in a clinical trial is a significant commitment.
We are grateful for the important contributions of the volunteers who take part in this important research.

See our FAQ section for information on the benefits and risks of participating in a clinical trial.

About the RTX‑321 Phase 1 Clinical Trial

This Phase 1 clinical trial is designed to evaluate whether the investigational cellular therapy, RTX-321, is well tolerated, how much RTX-321 needs to be given, how often it should be given and if RTX-321 has antitumor activity against the cancer. The trial seeks to evaluate:

  • Any side effects associated with RTX‑321
  • Preliminary dose and schedule, meaning how much RTX‑321 needs to be given, and how often it should be given

All study participants
receive RTX-321 at no cost:

The study drug, study-related services, supplies, procedures, and care performed as part of this study and not part of your routine medical care will be paid for by the study site, through the study Sponsor.

Who can participate?

Upon reviewing the clinical trial eligibility criteria, speak with your doctor about any questions you may have and whether the clinical trial is right for you.

Adults who meet the following criteria may be able to participate in the trial.

  • Men and women aged 18 or older.
  • Participants must be HLA-A*02:01 positive and have persistent, recurrent, or metastatic, unresectable cervical cancer (squamous cell carcinoma, adenocarcinoma, or adenocarcinoma and squamous cell carcinoma), head and neck squamous cell carcinoma (including nasal cavity cancer, oral cancer, laryngeal cancer, hypopharyngeal cancer, nasopharyngeal cancer, and oropharyngeal cancer) or squamous cell cancer of the anal canal that is not amenable to curative therapy.
  • Participants must have confirmed HPV 16-positive status (either with a test or medical history); patients with anal cancer will not be required to confirm HPV 16-positive status prior to enrollment.
  • All participants must have experienced disease progression following platinum-based or mitomycin C-based chemotherapy administered in the persistent, recurrent, or metastatic setting.
  • All patients with programmed death-ligand 1 (PD-L1) positive cervical cancer and those with HNSCC must have received or have been determined to be ineligible for immunotherapy with a PD-1 or PD L1 inhibitor.
  • Participants must have completed prior therapy, including radiation, at least 28 days prior to study treatment.
  • For females of reproductive potential, agreement to use highly effective contraceptive throughout and for six months following last dose study treatment.

What to expect if you are enrolled

Pre-screening

Participants in the trial will undergo:

  • Prescreening Informed Consent
  • HLA genotype testing to
    confirm HLA-A*02:01-positive
    status
  • HPV 16 testing to confirm positive status (applicable ONLY for patients with cervical cancer [unless an FDA-approved test result is already on file] and HNSCC and NOT for patients with anal cancer)
Screening and eligibility

Up to 28 days prior to receiving a dose of RTX-321

  • Study Informed Consent
  • A doctor’s exam and blood tests
  • An archived tumor sample pretreatment will be collected
On dosing days
  • Dosing day visits take approximately four to six hours
  • Patients will receive RTX-321 until the time in which the disease progresses, in the event of undesirable toxicities or withdrawal from study
Follow-up visits
  • Follow-up visits take approximately 1 hour
  • Follow-up visits occur weekly in all parts of the study. During the first three cycles, visits occur more frequently in the first week after RTX-321 is dosed with visits 24 and 48 hours after dosing
  • An optional, fresh biopsy may be collected after receiving two doses
Long term follow-up
  • As RTX-321 is a new type of therapy, after RTX-321 dosing is discontinued, patients participate in a long-term follow-up study to evaluate any long-term effects

Trial site locations

The Angeles Clinic & Research Institute
Los Angeles, California,
United States, 90025
 
Contact: Saba Mukarram
310-231-2181
SMukarram@theangelesclinic.org

Sarah Cannon Research Institute
Nashville, Tennessee,
United States, 37203
 
Contact: Sarah Cannon Research Site
615-329-7478
CANN.ResearchReferrals@scresearch.net

NYU Langone
New York, New York
United States, 10016

Siteman Cancer Center
St. Louis, Missouri
United States, 63110