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CAR-T therapy takes on tough lymphoma in Head-to-Head trial

NCT ID NCT05888493

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial tests whether a personalized cell therapy called tisagenlecleucel (CAR-T) works better than standard treatments for adults with follicular lymphoma that has come back or stopped responding. About 109 participants will receive either the CAR-T infusion or standard options like lenalidomide plus rituximab or R-CHOP chemotherapy. The main goal is to see how long people live without their cancer getting worse.

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 successful, this could offer a more effective treatment option for people with follicular lymphoma that has returned or not responded to prior therapies.
What could go wrong
This is an early-stage comparison, and CAR-T therapy can cause serious side effects like cytokine release syndrome. The trial is relatively small (109 participants), so results may not apply to everyone.

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

109 people

The number who actually took part.

Started

Oct 2023

Expected to finish

Feb 2031

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

18 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.

Inclusion Criteria: 1. Age ≥ 18 years at the date of signing the informed consent form. 2. Follicular lymphoma grade 1, 2, or 3A confirmed histologically after latest relapse (local assessment). 3. Relapsed or refractory disease after a second or later line of systemic therapy including an anti-CD20 antibody and an alkylating agent. 4. Disease that is both active on Positron emission tomography (PET) scan (defined as a score of 4 or 5 on the Deauville 5-point scale) and measurable on Computed tomography (CT) scan. 5. ECOG performance status of 0, 1 or 2 at screening. 6. Adequate hematologic, renal, hepatic and pulmonary organ function at screening. 7. Must meet the institutional criteria to undergo leukapheresis (unless historical leukapheresis is available). 8. Must be eligible for treatment with the selected standard of care regimen. Exclusion Criteria: 1. Follicular lymphoma grade 3B or evidence of histologic transformation. 2. Prior treatment with anti-CD19 therapy, gene therapy, or adoptive T-cell therapy. 3. Active CNS involvement by malignancy. 4. Clinically significant active infection, presence of Human immunodeficiency virus (HIV) antibody or active hepatitis B or C. 5. Active neurological autoimmune or inflammatory disorders (e.g., Guillain-Barré syndrome). 6. Investigational medicinal product within the last 30 days or five half-lives (whichever is longer) prior to randomization. 7. Clinically significant cardiovascular conditions such as acute coronary syndrome, significant cardiac arrhythmias, heart failure or decreased LVEF. Other protocol defined inclusion/exclusion criteria may apply

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Conditions

The condition(s) this trial relates to.

follicular lymphoma Recurrence

As listed by the trial registrant

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

Follicular lymphoma (FL)

Contacts and locations

Locations

  • Novartis Investigative Site

    Camperdown, New South Wales, 2050, Australia

  • Novartis Investigative Site

    Clayton, Victoria, 3168, Australia

  • Novartis Investigative Site

    Melbourne, Victoria, 3004, Australia

  • Novartis Investigative Site

    Nedlands, Western Australia, 6009, Australia

  • Novartis Investigative Site

    Salzburg, 5020, Austria

  • Novartis Investigative Site

    Montreal, Quebec, H1T 2M4, Canada

  • Novartis Investigative Site

    Ostrava, Poruba, 708 52, Czechia

  • Novartis Investigative Site

    Budapest, H-1097, Hungary

  • Novartis Investigative Site

    Poznan, Greater Poland Voivodeship, 60-355, Poland

  • Novartis Investigative Site

    Gliwice, Silesian Voivodeship, 44-101, Poland

  • Novartis Investigative Site

    Gdansk, 80-952, Poland

  • Novartis Investigative Site

    Lodz, 93-513, Poland

  • Novartis Investigative Site

    Singapore, 119074, Singapore

  • Novartis Investigative Site

    Bratislava, 83310, Slovakia

  • Novartis Investigative Site

    Seoul, 03080, South Korea

  • Novartis Investigative Site

    Seoul, 03722, South Korea

  • Novartis Investigative Site

    Seoul, 05505, South Korea

  • Novartis Investigative Site

    Seoul, 06351, South Korea

  • Novartis Investigative Site

    Seoul, 06591, South Korea

  • Novartis Investigative Site

    Santiago Compostela, A Coruna, 15706, Spain

  • Novartis Investigative Site

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

  • Novartis Investigative Site

    Santander, Cantabria, 39008, Spain

  • Novartis Investigative Site

    El Palmar, Murcia, 30120, Spain

  • Novartis Investigative Site

    Barcelona, 08035, Spain

  • Novartis Investigative Site

    Córdoba, 14004, Spain

  • Novartis Investigative Site

    Madrid, 28034, Spain

  • Novartis Investigative Site

    Salamanca, 37007, Spain

  • Novartis Investigative Site

    Kaohsiung City, 83301, Taiwan

  • Novartis Investigative Site

    Taichung, 407219, Taiwan

  • Novartis Investigative Site

    Taipei, 10002, Taiwan

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