Center for Cancer Research, National Cancer Institute, National Institutes of Health

Expanded Access Intelligence

Reagan-Udall Foundation Insights

Company
Center for Cancer Research, National Cancer Institute, National Institutes of Health
Additional Information

Single-Patient EA Policies/Criteria Due to the unique nature of personalized cell manufacturing and the high-level of monitoring required for patients treated with this product, an expanded access program to provide this therapy to patients at their local institution is not feasible at this time. For patients who may fit the indication to receive this therapy, and are between the ages of 3-30 with CD22 positive B-cell Acute Lymphoblastic Leukemia that is refractory or in second or later relapse, and either CD19 negative or relapsed/refractory to CD19 targeting, enrollment may be possible on the ongoing National Institutes of Health CD22 CAR T-cell clinical trial “Anti-CD22 Chimeric Receptor T Cells in Pediatric and Young Adults With Recurrent or Refractory CD22-expressing B Cell Malignancies” (NCT02315612). Available Therapies via Single-Patient EA https://clinicalstudies.info.nih.gov/ProtocolDetails.aspx?A_2015-C-0029.html

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