Frequently Asked Questions

RTX-224 and the Cancer Clinical Trial

How is RTX-224 designed to work?

  • The ultimate goal in developing RTX-224 is to provide patients a safe and effective new cancer treatment option.
  • RTX-224 is an investigational cellular therapy designed to activate the immune system to fight cancer.

What is the purpose of this clinical trial?

The purpose of the clinical trial is to find out whether RTX-224 administered as monotherapy is safe and how much RTX-224 needs to be given for it to be effective.

What type of solid tumors are included in the Phase 1/2 clinical study?

Tumors included in the RTX-224 study include non-small cell lung cancer, head and neck cancer, cutaneous melanoma, urothelial (bladder) cancer, and triple-negative breast cancer.

How is RTX-224 given to patients?

RTX-224 is given intravenously (IV), which means into a vein by a trained medical professional.

Do I have to undergo any preparation before receiving RTX-224?

Participants who join the trial will have a doctor’s exam, blood tests and additional lab work before receiving RTX-224.

What happens after RTX-224 is given?

  • Once participants receive the first dose of RTX-224, they will be closely observed and continue to be monitored over the treatment period until disease progression or the occurrence of undesirable toxicities.
  • After the last dose of RTX-224, 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 effects of RTX-224.
  • Long-term follow up assessments will occur every 30 days for the first two months and then annually thereafter.

What is the time commitment for this trial?

  • RTX-224 will require patients to be dosed every three weeks, with lab work and monitoring in between dosing. We anticipate patients will be in clinic weekly.
  • Dosing days will require patients to be in clinic for approximately six hours.

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

  • Patients cannot receive other investigational anti-cancer treatments while receiving doses of RTX-224.
  • 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-224 clinical trial, we do not anticipate that participation in the RTX-224 clinical trial will disqualify you from taking part in other future clinical trials.
  • 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-224 may also be able to participate in future RTX-224 trials, pending results of this trial.
  • Please speak with your doctor about any questions.

Does Rubius plan to open additional clinical trials for cancer?

  • Rubius Therapeutics plans to investigate RTX-224 in a Phase 2 portion of the RTX-224 clinical trial.
  • For information on all current Rubius Therapeutics clinical trials for cancer, you may visit: Rubiustrials.com or clinicaltrials.gov.

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

For more information about the RTX-224 Phase 1/2 clinical trial, please visit clinicaltrials.gov or sign up below to receive more information about the RTX-224 trial.