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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

EU Sees Unified Pathway For Drug/IVD Studies As Key To Future Research Investment

 
• By Vibha Sharma

As the EU tests the feasibility of a radical “all-in-one” procedure for combined drug and IVD studies, sponsors are being urged to approach this novel framework with flexibility and openness.

Woodcock: Do Not Do The Wrong Study, Even If Against US FDA Advice

 
• By Sarah Karlin-Smith

The former CDER director said she tells sponsors not to conduct an FDA-recommended study design or randomized trial if it will not work.

AI Will Bolster, Not Squelch, Patient Voice In Clinical Research, US FDA Says

 
• By Sue Sutter

Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.

UK Looks To Auto-Match NHS Patients With Clinical Trials To Boost Recruitment

 
• By Vibha Sharma

The UK government is making it easier for millions of people to participate in clinical trials and is boosting transparency around how studies are delivered across the National Health Service.

More from R&D

Woodcock: Do Not Do The Wrong Study, Even If Against US FDA Advice

 
• By Sarah Karlin-Smith

The former CDER director said she tells sponsors not to conduct an FDA-recommended study design or randomized trial if it will not work.

AI Will Bolster, Not Squelch, Patient Voice In Clinical Research, US FDA Says

 
• By Sue Sutter

Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.

UK Looks To Auto-Match NHS Patients With Clinical Trials To Boost Recruitment

 
• By Vibha Sharma

The UK government is making it easier for millions of people to participate in clinical trials and is boosting transparency around how studies are delivered across the National Health Service.