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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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

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

    RECRUITING

    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

    RECRUITING

    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