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

NCT ID NCT04094311

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 16, 2026 · Updated 3 times

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2019

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

0 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key inclusion criteria: * Signed informed consent/assent must be obtained for this study prior to participation in the study. * Patients for whom the final manufactured tisagenlecleucel product does not meet the commercial release specifications. * Not excluded from commercial manufacturing under the Health Authority-approved tisagenlecleucel prescribing information for their respective country/region. * OOS material has not been deemed to pose an undue safety risk to the patient. * Patient is suffering from a serious or life-threatening disease or condition. * Repeat leukapheresis is not clinically appropriate per the investigator assessment. Key exclusion criteria: For part 1, patients meeting any of the following criteria are not eligible for inclusion in this study: * Human immunodeficience virus (HIV) positive patients. * Patients with active replication of Hepatitis B virus (HBV) or Hepatitis C virus (HCV). * Patients with primary central nervous system (CNS) lymphoma. * History of hypersensitivity to any drugs or metabolites of similar chemical classes as tisagenlecleucel. * Uncontrolled active infection or inflammation. * Any medical condition identified by the investigator that may impact the assessment of the safety or efficacy outcomes in relation to study treatment. * Pregnant or nursing (lactating) women. For part 2, exclusion criteria are not set; however, administration should be performed in accordance with the latest versions of the package insert of CTL019.

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    49 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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, 5011194, Japan

  • Novartis Investigative Site

    RECRUITING

    Sapporo, Hokkaido, 0608543, Japan

  • Novartis Investigative Site

    RECRUITING

    Sapporo, Hokkaido, 0608648, 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, 2360004, Japan

  • Novartis Investigative Site

    RECRUITING

    Kumamoto, Kumamoto, 8608556, Japan

  • Novartis Investigative Site

    RECRUITING

    Kyoto, Kyoto, 6028566, Japan

  • Novartis Investigative Site

    RECRUITING

    Tsu, Mie-ken, 5148507, Japan

  • Novartis Investigative Site

    RECRUITING

    Sendai, Miyagi, 9808574, Japan

  • Novartis Investigative Site

    RECRUITING

    Matsumoto, Nagano, 3908621, Japan

  • Novartis Investigative Site

    RECRUITING

    Nagasaki, Nagasaki, 8528501, 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, 5900197, Japan

  • Novartis Investigative Site

    RECRUITING

    Suita, Osaka, 5650871, Japan

  • Novartis Investigative Site

    RECRUITING

    Izumo, Shimane, 6938501, Japan

  • Novartis Investigative Site

    RECRUITING

    Hamamatsu, Shizuoka, 4313192, Japan

  • Novartis Investigative Site

    RECRUITING

    Bunkyo Ku, Tokyo, 1138431, Japan

  • Novartis Investigative Site

    RECRUITING

    Bunkyo Ku, Tokyo, 1138655, Japan

  • Novartis Investigative Site

    RECRUITING

    Bunkyo Ku, Tokyo, 1138677, Japan

  • Novartis Investigative Site

    RECRUITING

    Bunkyo-ku, Tokyo, 1138519, Japan

  • Novartis Investigative Site

    RECRUITING

    Bunkyo-ku, Tokyo, 1138603, Japan

  • Novartis Investigative Site

    RECRUITING

    Chuo Ku, Tokyo, 1040045, Japan

  • Novartis Investigative Site

    RECRUITING

    Fuchū, Tokyo, 1838524, Japan

  • Novartis Investigative Site

    RECRUITING

    Fuchū, Tokyo, 1838561, Japan

  • Novartis Investigative Site

    RECRUITING

    Minato-ku, Tokyo, 1058471, 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, 5438555, Japan

  • Novartis Investigative Site

    RECRUITING

    Osaka, 5458586, Japan

  • Novartis Investigative Site

    RECRUITING

    Saitama, 3308777, Japan

  • Novartis Investigative Site

    RECRUITING

    Wakayama, 6418510, Japan

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