Frequently Questions
What are the symptoms of the various forms of B-cell lymphoma?
Signs may include:1
- Swollen lymph nodes or abdominal swelling and discomfort
- Night sweats
- Significant unintended weight loss
- Unexplained and persistent fever
- Persistent severe fatigue
1. Cleveland Clinic: B-Cell Lymphoma. LINK
What is Minimal Residual Disease (MRD) testing?
The ALPHA3 clinical study is evaluating whether giving a CAR T-cell product to patients who are MRD+ – before cancer can be seen on scans – may help eliminate remaining cancer cells and potentially prevent cancer from coming back. Treating cancer when only a very small amount is present may offer an advantage over waiting until it returns. Patients who are MRD- have a lower risk of their cancer returning, although it does not guarantee that the cancer will not come back.
Knowing your MRD status – whether positive or negative – may help ease some of the uncertainty during the post-treatment monitoring period.
2. Roschewski M, Kurtz DM, Westin JR, et al. Remission assessment by circulating tumor DNA in large B-cell lymphoma. J Clin Oncol. 2025;43(34):3652-3661. doi:10.1200/JCO-25-01534.
3. Kurtz, et.al. Circulating Tumor DNA Measurements as Early Outcome Predictors in Diffuse Large B-Cell Lymphoma. JCO 2018.
Who may be a good candidate to receive MRD screening, the first part of the ALPHA3 clinical study?
You may consider applying for this investigational screening and study if:
- You are aged 18 or older
- You have a recent diagnosis of diffuse large B-cell lymphoma (DLBCL) or a similar type of non-Hodgkin lymphoma as confirmed by your doctor
- You are scheduled to have, or are currently undergoing, standard treatment with chemotherapy, or you have recently finished treatment within the last approximately 1 month. For complete eligibility criteria please visit the study page on ClinicalTrials.gov here
What are the potential benefits of participating in ALPHA3?
The information that doctors and researchers learn in this study may help improve what they know about treatments for adult patients with DLBCL and similar types of lymphoma, and may potentially help other people in the future. Participants may also receive attentive care from specialists in the treatment of these blood cancers throughout the clinical study should they enroll.
Are there any costs to participate in this study?
For eligible patients who join part one of the study, the investigational MRD test will be provided at no cost. For eligible participants who join part two of the study and subsequently enroll into the ALPHA3 clinical study treatment arm, the study treatment (cema-cel) and study procedures that are not part of your standard of care will be provided at no cost. The study team will explain to you and your caregiver what the study pays for and what you or your insurance may need to pay for. Financial assistance for travel necessary to undergo testing may also be provided to eligible study participants. Talk to the study team at your treatment location for more information.
Are there any results from this study that can be shared with me?
Yes, preliminary results have been released. Contact your doctor for more information.
Are there any risks to participating?
In any clinical study for an investigational test or investigational drug, there are potential risks, such as treatment-related side effects or risks from the study activities. Cema-cel may cause side effects, some of which may require treatment. After the infusion, cema-cel stays in your body and keeps working. Your doctor will watch you closely for at least 14 days. The study staff at the clinical site will explain these potential risks before you decide if you want to participate, and address any concerns.
What is being researched in this study?
The ALPHA3 study aims to predict whose cancer might return and stop it before it happens. By participating in the first part of the ALPHA3 clinical study, you will help researchers learn if an investigational MRD test can predict whether a patient’s cancer is likely to return and, should you be eligible and decide to participate in the second part of the ALPHA3 study, if early treatment with a single dose of an investigational CAR T-cell product called cemacabtagene ansegedleucel (or “cema-cel,” pronounced “SEM-a-sell”) can potentially help prevent your cancer from returning.
Does eligibility ensure my participation in that clinical study?
If you choose to participate, the study staff will review medical history and conduct any required assessments. The next step will be to run the investigational MRD test to check if you still have any small amounts of cancer in your body that are too small to be seen on a scan. If the test shows you are MRD+, you may be able to participate in the second part of the ALPHA3 clinical study.
Can I change my mind about participating in a clinical study?
Yes. Participation in this study is voluntary. This means you don’t have to take part in the study, or you can take back your consent and stop participating in the study at any time and for any reason.
What will happen during the study?
The ALPHA3 study has two steps. First, doctors will run the investigational MRD test to check if you still have small amounts of cancer in your body that are too small to be seen on a standard scan. If you are MRD-, there may be a lower chance of your cancer coming back.
However, research shows that if you are MRD+, there is a greater chance that your cancer will come back, often within the first year after treatment. Participants who are found to have evidence of MRD may be asked to participate in the second part of the ALPHA3 study, which tests if early treatment with a single dose of an investigational CAR T-cell product called cemacabtagene ansegedleucel (or “cema-cel,” pronounced “SEM-a-sell”) may help eliminate the remaining cancer cells in the body and potentially prevent your cancer from returning.
Will enrollment in the study ensure that I receive the investigational drug?
No. After completing the first step of the ALPHA3 study, patients who are MRD+ may be eligible to join the second part of the study.
The second step of the study is randomized, which means that enrolled patients who are MRD+ are assigned by chance to one of two groups. There is a 50% chance of being assigned to each group.
Close Observation Group: Participants in this group do not receive cema-cel. They are monitored through frequent visits and scans, similar to the current approach for patients who have completed cancer treatment, but with closer, more frequent monitoring than they might receive outside the study. If the cancer returns, it may be detected earlier. Your doctor will discuss available treatment options with you.
Treatment Group: Participants in this group receive a single dose of cema-cel after an MRD+ result and before cancer is visible on scans. They are also monitored closely. While cema-cel is meant to help stop cancer from returning, there’s still a chance it could come back. If it does, your doctor will discuss other treatment options with you.
I’m a caregiver. Can I contact the study team on behalf of my loved one?
Yes. Caregivers can use this website to learn more about the ALPHA3 clinical study and help a loved one prepare questions for their doctor or study team. You may also contact the study team for more information, but your loved one may need to give permission before personal medical details can be discussed.
Where can I find an ALPHA3 study site near me?
What if I have more questions?
For more information on ALPHA3, please complete the request form here.
