Phase 1 study of SC262 allo CAR-T in R/R non-Hodgkin's Lymphoma - Clinical Trial
What is the Purpose of this Study?
We are doing this study to find the most effective, safe dose of an experimental drug called SC262 (the study drug) in people with relapsed and/or refractory non-Hodgkin's lymphoma.
Relapsed and/or Refractory non-Hodgkin's Lymphoma
Who Can Participate in the Study?
Adults ages 18+ who:
- Are diagnosed with non-Hodgkin's lymphoma
- Are not responding to treatment or had their cancer come back after treatment
- Are eligible to receive lymphodepleting chemotherapy
- Have had no more than 1 previous treatment with CD19-directed CAR T cell therapy
- Have never received any CD22-directed CAR T cell therapy or any other CD22-directed therapy
For more information about who can join this study, please contact the study team at 919-668-2556.
What is Involved?
If you choose to join this study, there will be a pre-study drug period that begins with you receiving 3 days of chemotherapy by infusion (a method of giving a drug using a needle or catheter through the vein) of 2 chemotherapy drugs (fludarabine and cyclophosphamide). This process, which is called "lymphodepletion," temporarily reduces the number of your existing immune cells and prepares your body to receive the study drug.
Lymphodepleting chemotherapy will be followed by the study drug procedure, when you will receive a single dose of the study drug through infusion in your vein. You will remain in the hospital or an accredited healthcare center for at least 14 days for observation and to check if you have any side effects from the study drug.
After completing the study drug procedures and the 14-day observation period, the study doctor or study staff will continue to monitor your health for the next 2 years.
The following tests and procedures will be performed throughout the study:
- Physical exams
- Electrocardiogram (ECG), a recording of the electrical activity of your heart
- Blood draws
- Bone marrow biopsy
- Lumbar puncture
- Imaging assessments
- Optional tumor biopsy
This study will last for up to 2 years.
Study Details
