How do I get started?
How will the investigational treatment be taken?
How often do I need to visit the doctor’s office?
How long will the study take place?
Is there a chance I will receive a placebo?
Is there any cost for me to participate?
Can I Participate?
You may be eligible to participate in this study if you:
Are 18 years of age or older
Have a confirmed diagnosis of scleroderma within the past 8 years
Have been told by your doctor that your scleroderma is refractory
‘Refractory’ means your scleroderma does not respond to standard therapies or medications.
Other eligibility criteria apply and will be evaluated by a study doctor if you choose to continue with screening for the study.
What is AlloNK® (AB-101)?
AlloNK®(AB-101) is an investigational treatment being studied to see if it can reduceB-cells that cause scleroderma. AlloNK® works by boosting your immune system using NK cells* from healthy donors, along with other treatments. NK cells help protect your body from harmful invaders.
When paired with another type of treatment called mAb therapy (example: rituximab), they may target the faulty B-cells that cause the symptoms of scleroderma. AlloNK® can be given outside of hospitals, in places like clinics or doctor’s offices, making it easier for you to potentially participate.
- *Natural killer (NK) cells: A type of immune cell that helps protect the body from infections and cancer. NK cells attack infected or abnormal cells but also avoid harming normal cells. NK cells are special because they can be used to treat many patients without needing gene editing or other genetic changes.
Why Should I Join
Artiva’s AlloNK® Study?
By enrolling in this study, you may receive:
Access to expert physicians with experience managing scleroderma.
Access to the investigational treatment at no cost to you.
- All costs for study-related treatment, as well as any study-related visits, tests, hospitalizations, and procedures, will be covered by the sponsor.
- The costs of travel, hotels, and meals associated with participation in the study will be covered by the sponsor.
Your participation supports the advancement of treatments for individuals with scleroderma.
What Should I Expect
Submit Online Questionnaire
This questionnaire will ask for your contact information and a few questions about your medical history to determine your eligibility.
Then, select a time for a short phone call with PatientWing. Submitting the questionnaire is voluntary and does not require a commitment to participate in the study.
Speak With PatientWing
PatientWing is partnering with Artiva Biotherapeutics, Inc. to help identify potential individuals who may be interested in Artiva’s AlloNK® Study.
You will have a short call to answer additional questions about your medical history and PatientWing will help collect your medical records.
Speak With a Research Site
If initial eligibility requirements are met during your conversation with PatientWing, you will then meet the research team who will review your medical records.
If the research team thinks you are a good fit, they will schedule a screening visit.
The research team will provide more information during your conversations with them. No question is a bad question so please share your concerns with the team.
Study Participation
After you've completed the screening period, the research team will notify you about your eligibility. If you are enrolled in the study, you should expect the following:
- You will receive a combination of AlloNK® and rituximab.
- There are around 26 in-person visits and 6 infusion days for each treatment cycle. Infusions can be done in an outpatient setting and do not require hospitalization.
- Treatment Cycle 1 will take place over 4 weeks. At 22 weeks, you doctor will perform an assessment to determine if Cycle 2 is needed based on how your body responds to the investigational treatment.
- Follow-up visits will occur around every three months beginning after your last treatment visit until the study ends.
- The study lasts around 2 years.
All study-related procedures, travel, meals, and lodging are covered by the sponsor.
Frequently Asked Questions
About the Study Team
About the Sponsor
Artiva Biotherapeutics, Inc. believes that patients deserve better. We are deeply committed to making cell therapies broadly accessible to patients with autoimmune disease.
About PatientWing
Our mission to bring better treatments to more people faster starts with you. We help sponsors find patients to participate in their clinical studies. With our focus on rare diseases and expertise in navigating the enrollment process, we're here for you every step of the way.
Stay Connected
Receive marketing communications from PatientWing such as patient stories and relevant clinical trial opportunities.
Have Questions?
At PatientWing, we’re here to support you at every step of the study. You can email, text, call or fill out the form with any questions. We’re here to help.
A clinical study for people with Scleroderma.
