Nitin Jain, MD, discusses the significance of a study of UCART22, an allogeneic chimeric antigen receptor T-cell therapy for patients with relapsed/refractory B-cell acute lymphoblastic leukemia.
Nitin Jain, MD, associate professor in the department of leukemia at The University of Texas MD Anderson Cancer Center, discusses the significance of a study of UCART22, an allogeneic chimeric antigen receptor (CAR) T-cell therapy for patients with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL).
CAR T-cell therapies are now approved by the FDA for lymphomas, multiple myeloma, and leukemia. UCART22 differs from currently approved therapies in 2 key ways, according to Jain. First, it targets the CD22 antigen, while existing therapies commonly target CD19 as a biomarker. CD22-targeted CAR T-cell therapies are not yet approved and there is limited clinical data on their efficacy so far.
Second, UCART22 is an off-the-shelf CAR T-cell product, making it more easily available. Patients do not need to undergo leukapheresis and wait for the CAR T cells to be manufactured before infusion.
The phase 1, open-label, dose-escalation BALLI-01 study (NCT04150497) is investigating the safety, tolerability, and maximum tolerated dose of UCART22 with lymphodepletion to improve efficacy. After reporting results from the first cohort who are receiving UCART22 and lymphodepletion, Jain says the next step is to observe CAR T-cell persistence and clinical activity at a higher dose level.
TRANSCRIPTION:
0:08 | Overall, I think the field of CAR T has continued to expand tremendously. You know, we already have approved products for both lymphomas, myeloma, and leukemias now, and including ALL. So I think this UCART22 represents another aspect of treating patients with a different target than CD19. Right now, none of the CD22-targeting [CAR T cells] are FDA approved. And the clinical data with CD22 targeting is actually quite limited. So the advantage, also, of UCAR products is that this is an off-the-shelf product so it's readily available to the patients. You don't have to wait for leukapheresis; you can give it to patients right away. So we hope and we'll have to see how this next year pans out, where we have to enroll patients at the next dose level, look for the safety [and] efficacy, and hopefully we'll see more CAR T persistence and clinical activity at the next dose level.