Frequently Asked Questions

The RTX-321 Clinical Trial

How is RTX-321 designed to work?

  • The ultimate goal in developing RTX-321 is to provide patients a new treatment option for HPV 16-associated cancers.
  • RTX-321 is an investigational cellular therapy that is engineered to selectively target HPV 16-associated cancers and potentially induce an immune response against the cancer, including cervical cancer, anal cancer and head and neck cancer (including nasal cavity cancer, oral cancer, laryngeal cancer, hypopharyngeal cancer, nasopharyngeal cancer, and oropharyngeal cancer).

What is the purpose of this clinical trial?

The purpose of the clinical trial is to find out 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 is effective.

What type of cancers are included in the Phase 1 clinical study?

The Phase 1 study will include HPV 16-associated cancers, including cervical cancer, anal cancer and head and neck cancer (including nasal cavity cancer, oral cancer, laryngeal cancer, hypopharyngeal cancer, nasopharyngeal cancer, and oropharyngeal cancer).

How is RTX-321 given to patients?

RTX-321 is given intravenously (IV), which means into a vein by a trained medical professional.

Do I have to undergo any preparation before receiving RTX-321?

Participants who join the trial will have a doctor’s exam, HLA genotype testing, blood tests and additional lab work before receiving RTX-321. HPV 16 testing will be performed to confirm positive status (applicable for cervical cancer unless an FDA-approved test result is already on file and HNSCC).

What happens after RTX-321 is given?

  • Once participants receive the first dose of RTX-321, they will be closely observed and continue to be monitored over the treatment period until disease progression, undesirable toxicities or withdrawal from the study.
  • After the last dose of RTX-321, the patient will participate in an end-of-treatment visit within 30 days of the last dose given.
  • Following the conclusion of study participation, patients will be monitored for up to 15 years for any potential incidence of long-term side effects of RTX-321.

Can I continue receiving any other anti-cancer therapies while on this trial?

  • Patients cannot receive other anti-cancer treatments while receiving RTX-321.
  • Once the final dose has been administered and the end of treatment visit has taken place, patients may go on to receive additional anti-cancer treatments.
  • Please speak with your doctor about any questions.

Will I be eligible for other trials if I choose to participate?

  • Although participants cannot be enrolled in other clinical trials while participating in the RTX-321 clinical trial, participants may be able to participate in other trials once dosing of RTX-321 is discontinued even if long-term follow-up is being evaluated. Please speak with your doctor with any questions regarding participating in clinical trials in the future.
  • It is important to note, however, that each trial has its own criteria regarding who can participate. Patients who participate in the Phase 1 trial for RTX-321 may also be able to participate in future RTX-321 trials, pending results of this trial.
  • Please speak with your doctor about any questions.

Does Rubius Therapeutics plan to open additional clinical trials for HPV-associated cancers?

  • Rubius Therapeutics plans to investigate RTX-321 in specific types of HPV-associated cancers that will be determined by the results of the Phase 1 RTX-321 clinical trial.

Does Rubius Therapeutics offer any financial assistance for trial participation?

All necessary travel and lodging costs related to trial participation will be covered by Rubius Therapeutics; the process for patient reimbursement may vary by trial site.

What precautions will be taken to minimize risk of COVID-19 transmission to patients who decide to participate in the trial?

Rubius Therapeutics is committed to the safety of all patients and clinicians participating in the trial. Each trial site has its own procedures to minimize the risk of COVID-19 transmission. If you have any questions, please speak directly with your physician.

For more information about the RTX-321 Phase 1 clinical trial, please visit clinicaltrials.gov or sign up below to receive more information about the RTX-321 trial.

RTX‑321 Phase 1 Clinical Trial

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Rubius Therapeutics is now enrolling patients in a phase 1 clinical trial of RTX-321 for the treatment of patients with HPV 16-associated cancers.

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Thank you! You may be a potential candidate for a study doctor to evaluate for participation in this study.

If you wish to be connected to a clinical trial site in the RTX-321 study, please fill in your contact information below. Someone from our Patient Advocacy Team may reach out to you to determine your interest and if you would meet the requirements to be evaluated by a study doctor for screening in the RTX-321 study. Your personal information, including information entered below and discussed with our Patient Advocacy Team, may then be shared with a clinical study site.

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Based on the information provided, you may not meet the requirements for this study. We want to thank you for your interest – patient volunteers and their family members are an essential part of the development of new therapies for cancer. If you still would like to learn more about Red Cell Therapeutics™ and receive updates about clinical trials that might be available in your area for the potential treatment of cancer for yourself or a loved one, sign up here.

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Someone from our Patient Advocacy Team may reach out to you to determine your interest and if you would meet the requirements to be evaluated by a study doctor for screening in the RTX-321 study. Your personal information, including information entered previously and discussed with our Patient Advocacy Team, may then be shared with a clinical study site.