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Acute Lymphoblastic Leukemia Poised To Be First, Fast Driver Of CAR Immunotherapy

 
• By Emily Hayes

Given high complete response rates in early studies showcased at the American Society of Hematology’s recent annual meeting, acute lymphoblastic leukemia is a likely launch indication for chimeric antigen receptor immunotherapy. But while the results in B-cell malignancies are very promising so far, autologous CAR therapies are complex, and toxicities need to be carefully managed.

The first regulatory testing ground for the current generation of gene engineering technology candidates based on chimeric antigen receptors is likely to be acute lymphoblastic leukemia, an indication in which therapies can target an antigen, CD19, that is expressed only on B-cells, limiting the possibility of off-target effects.

Early studies presented at the American Society of Hematology meeting in December spurred excitement about the autologous technology’s potential in...

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More from Clinical Trials

UK-Wide Strategy Needed To Move Clinical Trial Diversity Plans To Next Stage

 
• By Vibha Sharma

The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.

Trial Cancellations And Delays Persist For CROs Amid Biotech Slowdown

 
• By Vibha Sharma

The whole contract research organization industry is being impacted by the current volatility in the pharmaceutical industry.

What UK’s Clinical Trials Overhaul Means For Orphan Drug Developers

 
• By Eliza Slawther

The UK government has acknowledged that sponsors of clinical trials for rare diseases face challenges around patient recruitment and trial design, which will be addressed in its clinical trials reform, a lawyer says.

Orphan Drug Trial Sponsors ‘Playing Catch-Up’ With Regulators – But Automation Can Help

 
• By Eliza Slawther

Clinical trial sponsors in the rare disease space face “big safety demands” from regulators, which can be challenging for those with limited resources. A CRO founder makes the case for “embedding automation” into the clinical trial process to keep pace with regulatory requirements.

More from R&D

Orphan Drug Trial Sponsors ‘Playing Catch-Up’ With Regulators – But Automation Can Help

 
• By Eliza Slawther

Clinical trial sponsors in the rare disease space face “big safety demands” from regulators, which can be challenging for those with limited resources. A CRO founder makes the case for “embedding automation” into the clinical trial process to keep pace with regulatory requirements.

Nipah Vaccine With ‘Pandemic Potential’ Wins EMA PRIME Designation

 
• By Neena Brizmohun

The developers of the ChAdOx1 NipahB vaccine will be able to benefit from the early and enhanced support that the European Medicines Agency offers through its priority medicines scheme.

Elegy For SACHRP: US HHS Research Protection Panel Tackled Tough Pediatric Trial Questions

 
• By Bridget Silverman

The termination of the HHS Secretary’s Committee on Human Research Protections closed an important forum for discussing pediatrics and pregnancy in clinical trial design, a former SACHRP chair said.