FDA grants RMAT designation to HSCT adjunct

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T cells
Image from NIAID
The US Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to ATIR101™, which is intended to be used as an adjunct to haploidentical hematopoietic stem cell transplant (HSCT). ATIR101 is a personalized T-cell immunotherapy—a donor lymphocyte preparation selectively depleted of host-alloreactive T cells through... [Read Article]
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Team creates guidelines on CAR T-cell-related toxicity

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Sattva Neelapu, MD
Photo courtesy of MD
Anderson Cancer Center
Researchers say they have created guidelines for managing the unique toxicities associated with chimeric antigen receptor (CAR) T-cell therapy. The guidelines focus on cytokine release syndrome (CRS); neurological toxicity, which the researchers have dubbed “CAR-T-cell-related encephalopathy syndrome (CRES);” and adverse effects related to... [Read Article]
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Immune status linked to outcomes of CAR T-cell therapy

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Micrograph showing DLBCL
Outcomes of treatment with a third-generation chimeric antigen receptor (CAR) T-cell therapy are associated with a patient’s immune status, according to a phase 1/2a trial. The CD19-specific CAR T-cell therapy produced a complete response (CR) in 6 of 15 patients with relapsed/refractory CD19-positive leukemia or lymphoma. Though all responders eventually... [Read Article]
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FDA approves drug to treat CRS induced by CAR T-cell therapy

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Tocilizumab (Actemra®)
Photo courtesy of Roche
The US Food and Drug Administration (FDA) has approved tocilizumab (Actemra®) for the treatment of patients age 2 and older who have severe or life-threatening cytokine release syndrome (CRS) induced by chimeric antigen receptor (CAR) T-cell therapy. Tocilizumab is a humanized interleukin-6 receptor antagonist. The drug is... [Read Article]
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