Frequently Asked Questions

You may consider applying for this diagnostic 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

The information that doctors and researchers learn in this study may help improve what they know about treatments for adult patients with diffuse large B-cell lymphoma (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 during the MRD screening, and the administration of the one-time ALPHA3 dosage, should they enroll.

In any clinical study for a new test or new drug, there are potential risks, such as treatment-related side effects or risks from the study activities. The study staff at the clinical site will explain these potential risks before you decide if you want to participate, and address any concerns.

The ALPHA3 clinical trial is different from other clinical trials. It aims to predict whose cancer might return and try to potentially prevent it before it happens. By participating in the first part of the ALPHA3 clinical trial, you will help us 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 clinical trial, if a one-time treatment with a single dose of a CAR T‑cell therapy can prevent it from coming back.

If you choose to participate, the study staff will review medical history and conduct any relevant 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 invited to consider participating in the second step of the ALPHA3 clinical study.

Yes. Participation in this study is voluntary. This means that you can take back your consent and stop participating in the study at any time and for any reason.

The ALPHA3 trial has two steps. First, doctors will 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 standard scan. If you are MRD- your cancer is statistically unlikely to come back. However, research shows that if you are MRD+, there is a greater chance that your cancer will come back, and that it may return within the next 12 months. Participants who are found to have evidence of MRD+ may be asked to participate in the second step in the ALPHA3 study, which tests if early treatment with CAR T‑cell therapy using a single dose of an investigational product called cemacabtagene ansegedleucel (or “cema-cel,” pronounced “SEM-a-sell”) can help try and prevent your cancer from returning.

No. After completing the first step of the ALPHA3 clinical study, patients who are found to have evidence of minimal residual disease (MRD+) may be eligible to join the second step of the ALPHA3 clinical study. This part of the trial is randomized, which means that patients will be assigned to one of two different study groups by chance. The likelihood of being randomly placed into the group that does not receive the investigational CAR T‑cell product (“cema-cel”) is 50%.

For more information on ALPHA3 clinical study, please complete the request form here.