Study of Out of Specification for Tisagenlecleucel
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
This study will evaluate the safety of tisagenlecleucel that is out of specification( OOS) for release as commercial product. Specifically, this study will evaluate the safety of CTL019 in the patients treated within the approved label by Japan Health Authority in Part 2. Only for Part 1, in addition to safety, key efficacy of CTL019 will also be evaluated.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Pacjent lub opiekun musi podpisać zgodę na udział w badaniu
- •Pacjent, u którego wyprodukowany lek nie spełnia wszystkich standardów do sprzedaży
- •Pacjent nie został wykluczony z handlowych procedur wytwarzania leku
- •Lek nie stanowi dodatkowego ryzyka dla zdrowia pacjenta
- •Pacjent cierpi na poważną lub zagrażającą życiu chorobę
- •Pobranie kolejnej porcji komórek nie jest możliwe lub bezpieczne
✗ Disqualifies
- •Pacjenci z wirusem HIV
- •Pacjenci z aktywnym zakaźeniem wirusem zapalenia wątroby B lub C
- •Pacjenci z pierwotnym nowotworem ośrodkowego układu nerwowego
- •Historia alergii na lek lub podobne substancje
- •Niekontrolowana infekcja lub stan zapalny
- •Pacjentki w ciąży lub karmiące piersią
Simplified criteria — AI translation
Trial details
- Minimum age
- 0 Years
- Maximum age
- 100 Years
- Last updated (source)
- September 15, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (55)
Novartis Investigative Site
Hamilton, Canada
Novartis Investigative Site
Ottawa, Canada
Novartis Investigative Site
Toronto, Canada
Novartis Investigative Site
Toronto, Canada
Novartis Investigative Site
Montreal, Canada
Novartis Investigative Site
Québec, Canada
Novartis Investigative Site
Nagoya, Japan
Novartis Investigative Site
Nagoya, Japan
Novartis Investigative Site
Tōon, Japan
Novartis Investigative Site
Gifu, Japan
Novartis Investigative Site
Sapporo, Japan
Novartis Investigative Site
Sapporo, Japan
Novartis Investigative Site
Kobe, Japan
Novartis Investigative Site
Nishinomiya, Japan
Novartis Investigative Site
Tsukuba, Japan
Novartis Investigative Site
Kita-gun, Japan
Novartis Investigative Site
Yokohama, Japan
Novartis Investigative Site
Kumamoto, Japan
Novartis Investigative Site
Kyoto, Japan
Novartis Investigative Site
Tsu, Japan
Novartis Investigative Site
Sendai, Japan
Novartis Investigative Site
Matsumoto, Japan
Novartis Investigative Site
Nagasaki, Japan
Novartis Investigative Site
Yufu, Japan
Novartis Investigative Site
Kurashiki, Japan
Novartis Investigative Site
Izumi, Japan
Novartis Investigative Site
Izumisano, Japan
Novartis Investigative Site
Osaka, Japan
Novartis Investigative Site
Sakai, Japan
Novartis Investigative Site
Suita, Japan
Novartis Investigative Site
Izumo, Japan
Novartis Investigative Site
Hamamatsu, Japan
Novartis Investigative Site
Bunkyo Ku, Japan
Novartis Investigative Site
Bunkyo Ku, Japan
Novartis Investigative Site
Bunkyo Ku, Japan
Novartis Investigative Site
Bunkyo-ku, Japan
Novartis Investigative Site
Bunkyo-ku, Japan
Novartis Investigative Site
Chuo Ku, Japan
Novartis Investigative Site
Fuchū, Japan
Novartis Investigative Site
Fuchū, Japan
Novartis Investigative Site
Minato-ku, Japan
Novartis Investigative Site
Setagaya-ku, Japan
Novartis Investigative Site
Shinjuku-ku, Japan
Novartis Investigative Site
Aomori, Japan
Novartis Investigative Site
Chiba, Japan
Novartis Investigative Site
Fukuoka, Japan
Novartis Investigative Site
Hiroshima, Japan
Novartis Investigative Site
Ishikawa, Japan
Novartis Investigative Site
Kyoto, Japan
Novartis Investigative Site
Niigata, Japan
Novartis Investigative Site
Okayama, Japan
Novartis Investigative Site
Osaka, Japan
Novartis Investigative Site
Osaka, Japan
Novartis Investigative Site
Saitama, Japan
Novartis Investigative Site
Wakayama, Japan
Trial contact
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/16/2026.
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