Actively Recruiting
Study of Out of Specification for Tisagenlecleucel
Led by Novartis Pharmaceuticals · Updated on 2026-04-20
200
Participants Needed
53
Research Sites
383 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of Out of Specification for Tisagenlecleucel
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent/assent before participation
- Patient's final tisagenlecleucel batch does not meet commercial release specifications
- Not excluded from commercial manufacturing as per local prescribing information
- Out of specification material is not considered an undue safety risk
- Patient has a serious or life-threatening disease
- Repeat leukapheresis is not clinically appropriate according to investigator
You will not qualify if you...
- HIV positive patients (Part 1 only)
- Active replication of Hepatitis B or C virus (Part 1 only)
- Primary central nervous system lymphoma (Part 1 only)
- History of hypersensitivity to drugs similar to tisagenlecleucel (Part 1 only)
- Uncontrolled active infection or inflammation (Part 1 only)
- Any medical condition affecting safety or efficacy assessment (Part 1 only)
- Pregnant or nursing women (Part 1 only)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 53 locations
1
Novartis Investigative Site
Hamilton, Ontario, Canada, L8V 5C2
Completed
2
Novartis Investigative Site
Ottawa, Ontario, Canada, K1H 8L6
Withdrawn
3
Novartis Investigative Site
Toronto, Ontario, Canada, M5G 1X8
Completed
4
Novartis Investigative Site
Toronto, Ontario, Canada, M5G 2M9
Completed
5
Novartis Investigative Site
Montreal, Quebec, Canada, H1T 2M4
Withdrawn
6
Novartis Investigative Site
Québec, Quebec, Canada, G1R 2J6
Withdrawn
7
Novartis Investigative Site
Nagoya, Aichi-ken, Japan, 4668560
Actively Recruiting
8
Novartis Investigative Site
Nagoya, Aichi-ken, Japan, 4678602
Actively Recruiting
9
Novartis Investigative Site
Tōon, Ehime, Japan, 7910295
Actively Recruiting
10
Novartis Investigative Site
Gifu, Gifu, Japan, 501-1194
Actively Recruiting
11
Novartis Investigative Site
Sapporo, Hokkaido, Japan, 060-8648
Actively Recruiting
12
Novartis Investigative Site
Sapporo, Hokkaido, Japan, 0608543
Actively Recruiting
13
Novartis Investigative Site
Kobe, Hyōgo, Japan, 6500047
Actively Recruiting
14
Novartis Investigative Site
Nishinomiya, Hyōgo, Japan, 6638501
Actively Recruiting
15
Novartis Investigative Site
Tsukuba, Ibaraki, Japan, 3058576
Actively Recruiting
16
Novartis Investigative Site
Kita-gun, Kagawa-ken, Japan, 7610793
Actively Recruiting
17
Novartis Investigative Site
Yokohama, Kanagawa-ku, Japan, 236-0004
Actively Recruiting
18
Novartis Investigative Site
Kyoto, Kyoto, Japan, 602-8566
Actively Recruiting
19
Novartis Investigative Site
Tsu, Mie-ken, Japan, 514-8507
Actively Recruiting
20
Novartis Investigative Site
Sendai, Miyagi, Japan, 9808574
Actively Recruiting
21
Novartis Investigative Site
Matsumoto, Nagano, Japan, 3908621
Actively Recruiting
22
Novartis Investigative Site
Nagasaki, Nagasaki, Japan, 852-8501
Actively Recruiting
23
Novartis Investigative Site
Yufu, Oita Prefecture, Japan, 8795593
Actively Recruiting
24
Novartis Investigative Site
Kurashiki, Okayama-ken, Japan, 7108602
Actively Recruiting
25
Novartis Investigative Site
Izumi, Osaka, Japan, 5941101
Actively Recruiting
26
Novartis Investigative Site
Izumisano, Osaka, Japan, 5988577
Actively Recruiting
27
Novartis Investigative Site
Osaka, Osaka, Japan, 5418567
Actively Recruiting
28
Novartis Investigative Site
Sakai, Osaka, Japan, 590-0197
Actively Recruiting
29
Novartis Investigative Site
Suita, Osaka, Japan, 565-0871
Actively Recruiting
30
Novartis Investigative Site
Izumo, Shimane, Japan, 6938501
Actively Recruiting
31
Novartis Investigative Site
Hamamatsu, Shizuoka, Japan, 4313192
Actively Recruiting
32
Novartis Investigative Site
Bunkyo Ku, Tokyo, Japan, 113-8655
Actively Recruiting
33
Novartis Investigative Site
Bunkyo Ku, Tokyo, Japan, 1138431
Actively Recruiting
34
Novartis Investigative Site
Bunkyo Ku, Tokyo, Japan, 1138677
Actively Recruiting
35
Novartis Investigative Site
Bunkyo-ku, Tokyo, Japan, 1138519
Actively Recruiting
36
Novartis Investigative Site
Chuo Ku, Tokyo, Japan, 1040045
Actively Recruiting
37
Novartis Investigative Site
Fuchū, Tokyo, Japan, 1838524
Actively Recruiting
38
Novartis Investigative Site
Minato-ku, Tokyo, Japan, 105-8471
Actively Recruiting
39
Novartis Investigative Site
Setagaya-ku, Tokyo, Japan, 1578535
Actively Recruiting
40
Novartis Investigative Site
Shinjuku-ku, Tokyo, Japan, 1608582
Actively Recruiting
41
Novartis Investigative Site
Aomori, Japan, 0308553
Actively Recruiting
42
Novartis Investigative Site
Chiba, Japan, 2608677
Actively Recruiting
43
Novartis Investigative Site
Fukuoka, Japan, 8128582
Actively Recruiting
44
Novartis Investigative Site
Hiroshima, Japan, 7348551
Actively Recruiting
45
Novartis Investigative Site
Ishikawa, Japan, 9208641
Actively Recruiting
46
Novartis Investigative Site
Kumamoto, Japan, 860-8556
Actively Recruiting
47
Novartis Investigative Site
Kyoto, Japan, 6068507
Actively Recruiting
48
Novartis Investigative Site
Niigata, Japan, 9518520
Actively Recruiting
49
Novartis Investigative Site
Okayama, Japan, 7008558
Actively Recruiting
50
Novartis Investigative Site
Osaka, Japan, 543-8555
Actively Recruiting
51
Novartis Investigative Site
Osaka, Japan, 5458586
Actively Recruiting
52
Novartis Investigative Site
Saitama, Japan, 330-8777
Actively Recruiting
53
Novartis Investigative Site
Wakayama, Japan, 641-8510
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here