Testing a modified cell therapy when product quality is off-spec
Part of Blood & lymphatic, Cancer, Immune system & allergy, Infections clinical trials.
This study looks at using tisagenlecleucel, a cell therapy, when the final product does not meet routine “commercial release” quality standards. It focuses on whether it can still be given safely and effectively to people with serious or life-threatening illness.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You (or your guardian) can sign consent and agree to join the study.
- Your final batch of tisagenlecleucel did not meet the usual quality requirements.
- Your case is not excluded from using tisagenlecleucel under your country’s approved prescribing information.
- The study team believes the off-spec product is not an undue safety risk for you.
- You have a serious or life-threatening condition, and repeat blood collection (leukapheresis) is not appropriate for you.
Quick eligibility check
Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.
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