Single-arm Study of IgPro20 in Adults With Secondary Immune Deficiencies Due to Hematologic Malignancies Treated With B-cell Targeting Chimeric Antigen Receptor T-cell and T-cell Redirecting Therapies
This study is for adults whose immune systems are weakened because of treatments for blood cancers like lymphoma or myeloma. These treatments include special cell therapies (like CAR T-cell therapy) or other targeted medicines. When the immune system is weak, people are more likely to get serious infections. The study is looking at a medicine called IgPro20. Its main goal is to see if taking IgPro20 can help prevent serious bacterial infections. Researchers also want to check how safe IgPro20 is and how the body uses it. If successful, this medicine could offer important protection for people recovering from these cancer treatments.
At a glance
What is this study about?
Imagine your body's immune system as your personal army, fighting off germs and keeping you healthy. Sometimes, powerful treatments for blood cancers, like certain types of cell therapy (CAR T-cell therapy) or other targeted medicines, can unintentionally weaken this army. This means you might not have enough 'soldiers' (called antibodies) to protect you from serious infections.
This study is testing a medicine called IgPro20. This medicine is designed to give your immune system a boost by providing those missing protective antibodies. The main thing the researchers want to find out is if people taking IgPro20 get fewer serious bacterial infections. They hope to show that the rate of serious infections is very low, less than one per person each year.
There will be two groups in the study. One group is for people whose antibody levels are quite low at the start, and they'll get a few initial doses of IgPro20. The other group is for people who are already receiving similar antibody treatments and have higher levels, and they will receive an initial dose. By studying these groups, researchers can understand how best to use IgPro20 to protect people with weakened immune systems after specific cancer treatments.
Key takeaways
- This study is for adults with a weakened immune system after blood cancer treatments.
- It tests a medicine called IgPro20 to see if it can prevent serious infections.
- Participants must have had specific cell therapies (CAR T-cell or T-cell redirecting therapies).
- The study will check the safety of IgPro20 and how well it works.
- There are two groups based on current antibody levels and ongoing treatment.
Who may be eligible?
To join this study, you generally need to be at least 18 years old and have a confirmed diagnosis of a certain type of blood cancer, like Multiple Myeloma, Chronic Lymphocytic Leukemia, or Non-Hodgkin Lymphoma.
You must have recently had a specific kind of cancer treatment, either CAR T-cell therapy (at least 2 months ago) or a T-cell redirecting therapy (at least 1 month ago) and are expected to continue this treatment. It's also important that your cancer has responded well to these treatments, either partially or completely.
Finally, your levels of a certain type of antibody called IgG will be checked. Depending on whether you're already receiving antibody replacement therapy and what your IgG level is, you'll be placed into one of two study groups.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have a diagnosis of a B-cell blood cancer (like Lymphoma or Myeloma)?
- Have you recently had CAR T-cell therapy or a T-cell redirecting therapy?
- Has your cancer responded well to these treatments?
- Are you prepared to have your antibody levels checked regularly?
What does participation involve?
If you join this study, you will receive a medicine called IgPro20. The amount and frequency will depend on your initial antibody levels and which group you are in. You will have regular visits to the clinic where doctors and nurses will monitor your health, take blood samples to check your antibody levels and look for any side effects, and assess whether you are getting any infections.
The study will involve several visits over a period of time to track your progress and ensure your safety. The exact number and timing of visits will be explained by the study team. You'll need to answer questions about how you're feeling and report any new symptoms or infections. The total duration of your involvement in the study will be determined by the study design, but generally, these types of studies involve consistent monitoring over several months.
Potential risks and benefits
Locations (60)
- UC IrvineVerified postcodeOrange, United States
- CBCI, Colorado Blood Cancer InstituteVerified postcodeDenver, United States
- SSAK PartnersVerified postcodeCoral Springs, United States
- Mayo Clinic - JacksonvilleVerified postcodeJacksonville, United States
- Indiana University Health Arnett, Inc.Verified postcodeLafayette, United States
- Johns Hopkins Asthma & Allergy CenterVerified postcodeBaltimore, United States
- American Oncology Partners, PA dba The Center for Cancer and Blood DisordersVerified postcodeBethesda, United States
- Hackensack Meridian HealthVerified postcodeHackensack, United States
- Carol G Simon Cancer CenterVerified postcodeMorristown, United States
- David H. Koch Center for Cancer CareVerified postcodeNew York, United States
- Montefiore Medical Center PRIMEVerified postcodeThe Bronx, United States
- Duke UniversityVerified postcodeDurham, United States
Common questions
What is IgPro20?
IgPro20 is a medicine that provides extra antibodies to help your immune system fight off infections.
Why is this study important?
It's important because it aims to reduce serious infections in people whose immune systems are weakened by certain cancer treatments.
What kind of cancer treatments are involved?
The study focuses on people who have had specific cell therapies (like CAR T-cell therapy) or T-cell redirecting therapies for blood cancers.
Will I know if I'm getting the active medicine?
This is an 'open-label' study, meaning both you and the study doctors will know you are receiving IgPro20.
What does a 'weakened immune system' mean?
It means your body's natural defenses against germs are not as strong as they should be, making you more prone to illness.
How to find out more
Trial Registration Coordinator
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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