Second-Chance CAR-T: could Off-Spec cells still fight cancer?

NCT ID NCT04094311

Recruiting now Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This phase 3 trial is testing a CAR-T cell therapy called tisagenlecleucel that didn't quite meet commercial release standards. It's for people with B-cell acute lymphoblastic leukemia or diffuse large B-cell lymphoma who have no other approved options. The study will check if these slightly off-spec cells are still safe and can help control the cancer.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: tisagenlecleucel (a CAR-T cell therapy made from the patient's own immune cells)
What this could lead to: If it works, this could provide a treatment option for patients whose manufactured CAR-T cells don't quite meet commercial standards, potentially expanding access to this therapy.
What could go wrong: This is an early-phase study with only 200 participants, and the therapy is 'out of specification'—meaning it didn't meet normal release criteria—so safety and effectiveness are still uncertain.

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Conditions

The condition(s) this trial relates to.

acute lymphoblastic leukemia B-cell acute lymphoblastic leukemia Burkitt lymphoma diffuse large B-cell lymphoma high grade B-cell lymphoma non-Hodgkin lymphoma Precursor Cell Lymphoblastic Leukemia-Lymphoma Recurrence relapsed/refractory diffuse large B-cell lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

B-CELL ACUTE LYMPHOBLASTIC LEUKEMIA DIFFUSE LARGE B-CELL LYMPHOMA

Contacts and locations

Locations

Novartis Investigative Site
COMPLETED

Hamilton, Ontario, L8V 5C2, Canada
Novartis Investigative Site
WITHDRAWN

Ottawa, Ontario, K1H 8L6, Canada
Novartis Investigative Site
COMPLETED

Toronto, Ontario, M5G 1X8, Canada
Novartis Investigative Site
COMPLETED

Toronto, Ontario, M5G 2M9, Canada
Novartis Investigative Site
WITHDRAWN

Montreal, Quebec, H1T 2M4, Canada
Novartis Investigative Site
WITHDRAWN

Québec, Quebec, G1R 2J6, Canada
Novartis Investigative Site
RECRUITING

Nagoya, Aichi-ken, 4668560, Japan
Novartis Investigative Site
RECRUITING

Nagoya, Aichi-ken, 4678602, Japan
Novartis Investigative Site
RECRUITING

Tōon, Ehime, 7910295, Japan
Novartis Investigative Site
RECRUITING

Gifu, Gifu, 501-1194, Japan
Novartis Investigative Site
RECRUITING

Sapporo, Hokkaido, 060-8648, Japan
Novartis Investigative Site
RECRUITING

Sapporo, Hokkaido, 0608543, Japan
Novartis Investigative Site
RECRUITING

Kobe, Hyōgo, 6500047, Japan
Novartis Investigative Site
RECRUITING

Nishinomiya, Hyōgo, 6638501, Japan
Novartis Investigative Site
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Tsukuba, Ibaraki, 3058576, Japan
Novartis Investigative Site
RECRUITING

Kita-gun, Kagawa-ken, 7610793, Japan
Novartis Investigative Site
RECRUITING

Yokohama, Kanagawa, 236-0004, Japan
Novartis Investigative Site
RECRUITING

Kumamoto, Kumamoto, 860-8556, Japan
Novartis Investigative Site
RECRUITING

Kyoto, Kyoto, 602-8566, Japan
Novartis Investigative Site
RECRUITING

Tsu, Mie-ken, 514-8507, Japan
Novartis Investigative Site
RECRUITING

Sendai, Miyagi, 9808574, Japan
Novartis Investigative Site
RECRUITING

Matsumoto, Nagano, 3908621, Japan
Novartis Investigative Site
RECRUITING

Nagasaki, Nagasaki, 852-8501, Japan
Novartis Investigative Site
RECRUITING

Yufu, Oita Prefecture, 8795593, Japan
Novartis Investigative Site
RECRUITING

Kurashiki, Okayama-ken, 7108602, Japan
Novartis Investigative Site
RECRUITING

Izumi, Osaka, 5941101, Japan
Novartis Investigative Site
RECRUITING

Izumisano, Osaka, 5988577, Japan
Novartis Investigative Site
RECRUITING

Osaka, Osaka, 5418567, Japan
Novartis Investigative Site
RECRUITING

Sakai, Osaka, 590-0197, Japan
Novartis Investigative Site
RECRUITING

Suita, Osaka, 565-0871, Japan
Novartis Investigative Site
RECRUITING

Izumo, Shimane, 6938501, Japan
Novartis Investigative Site
RECRUITING

Hamamatsu, Shizuoka, 4313192, Japan
Novartis Investigative Site
RECRUITING

Bunkyo Ku, Tokyo, 113-8655, Japan
Novartis Investigative Site
RECRUITING

Bunkyo Ku, Tokyo, 1138431, Japan
Novartis Investigative Site
RECRUITING

Bunkyo Ku, Tokyo, 1138677, Japan
Novartis Investigative Site
RECRUITING

Bunkyo-ku, Tokyo, 113-8603, Japan
Novartis Investigative Site
RECRUITING

Bunkyo-ku, Tokyo, 1138519, Japan
Novartis Investigative Site
RECRUITING

Chuo Ku, Tokyo, 1040045, Japan
Novartis Investigative Site
RECRUITING

Fuchū, Tokyo, 1838524, Japan
Novartis Investigative Site
RECRUITING

Minato-ku, Tokyo, 105-8471, Japan
Novartis Investigative Site
RECRUITING

Setagaya-ku, Tokyo, 1578535, Japan
Novartis Investigative Site
RECRUITING

Shinjuku-ku, Tokyo, 1608582, Japan
Novartis Investigative Site
RECRUITING

Aomori, 0308553, Japan
Novartis Investigative Site
RECRUITING

Chiba, 2608677, Japan
Novartis Investigative Site
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Fukuoka, 8128582, Japan
Novartis Investigative Site
RECRUITING

Hiroshima, 7348551, Japan
Novartis Investigative Site
RECRUITING

Ishikawa, 9208641, Japan
Novartis Investigative Site
RECRUITING

Kyoto, 6068507, Japan
Novartis Investigative Site
RECRUITING

Niigata, 9518520, Japan
Novartis Investigative Site
RECRUITING

Okayama, 7008558, Japan
Novartis Investigative Site
RECRUITING

Osaka, 543-8555, Japan
Novartis Investigative Site
RECRUITING

Osaka, 5458586, Japan
Novartis Investigative Site
RECRUITING

Saitama, 330-8777, Japan
Novartis Investigative Site
RECRUITING

Wakayama, 641-8510, Japan

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