ASH 2023 | CD-7 targeted CAR-T therapy in heavily pretreated patients with AML: a Phase I trial
Approximately 30% of patients with acute myeloid leukemia (AML) have CD7-positive disease due to the expression of CD7 on leukemic blasts and malignant progenitor cells. Peihua Lu, MD, Beijing Lu Daopei Institute of Hematology, and Hebei Yanda Lu Daopei Hospital, Langfang, China, discusses the findings of a Phase I clinical trial (NCT04938115) which investigated the safety and efficacy of CD-7 targeted CAR T-cell therapy in heavily pretreated pediatric and adult patients with AML who had a CD7 expression of at least 50%. Four weeks after CAR-T, 70% of patients achieved complete remission (CR), and the safety profile of the therapy was manageable. This interview took place at the 65th ASH Annual Meeting and Exposition, held in San Diego, CA.
These works are owned by Magdalen Medical Publishing (MMP) and are protected by copyright laws and treaties around the world. All rights are reserved.
Transcript (edited for clarity)
We are very excited about this Phase I clinical trial, even though this is a Phase I clinical trial, I think we can learn a lot from it. You know, everyone in the field now, the treatment for refractory and relapsed AML really needs a new treatment strategy because, generally speaking, this group of patients have poor outcome even with stem cell transplantation. So CAR-T will be the next step and hopefully we can get to that...
We are very excited about this Phase I clinical trial, even though this is a Phase I clinical trial, I think we can learn a lot from it. You know, everyone in the field now, the treatment for refractory and relapsed AML really needs a new treatment strategy because, generally speaking, this group of patients have poor outcome even with stem cell transplantation. So CAR-T will be the next step and hopefully we can get to that.
So, in this trial, we know that for AML, about 30% of patients express CD7 on their blast surface [and this] can be [used] as a target. So in this Phase I clinical trial, we are using anti-CD7 CAR-T therapy to treat those CD7-positive AML patients. So even though we only [enrolled] ten patients, you know, we can learn a lot. And in those ten patients, one of the requirements is for patients to have more than 50% CD7 expression. And we put [enrolled] both pediatric and adult patients. The median bone marrow blast was 17%, but it could be as high as 73%. And in addition, in those patients, the median [number of prior lines of therapy] was eight and 70% of our patients were relapsed from previous allotransplantation. So really heavily pretreated, poor outcome patients.
However, after the CAR-T therapy, four weeks after CAR-T therapy, when doing the evaluation, you can see 70% were able to achieve the complete remission, and the majority of those are deep, complete remissions. So we are very encouraged about those results.
For the longer follow-up, [for] some of the patients [this is] even up to 770 days and they still have no relapse, even though eventually that patient died from an infection from their second allotransplantation. And we have other patients doing well, leukemia free around day 400. And, some other patients may, you know, we find to have some early relapse, however we identified that they actually had CD7 antigen loss. But overall, we are happy and the safety profile is actually pretty good and manageable. Certainly we need to include more patients into that study for the longer follow-up.
Read more...
