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Comparing tisagenlecleucel to standard treatment for relapsed follicular lymphoma

A Randomized, Open-label, Multi-center Phase III Trial Comparing Tisagenlecleucel to Standard of Care in Adult Participants With Relapsed or Refractory Follicular Lymphoma (FL)

Phase 3 Interventional Novartis · NCT05888493

This study is testing whether a new CAR-T cell therapy called tisagenlecleucel can help adults with relapsed follicular lymphoma do better than the usual treatments they’ve already tried.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment108 (estimated)
Ages18 Years to 100 Years
SexAll
SponsorNovartis Industry-sponsored
Locations35 sites (Cincinnati, Ohio and 34 other locations)
Trial IDNCT05888493 on ClinicalTrials.gov

What this trial studies

This phase III trial aims to evaluate the effectiveness of tisagenlecleucel, a CAR-T cell therapy, in treating adult patients with relapsed or refractory follicular lymphoma (r/r FL). Participants will be randomized to receive either tisagenlecleucel or standard of care therapies, such as R2 or R-CHOP, after having undergone at least two prior lines of systemic treatment. The primary endpoint is progression-free survival (PFS), which will be assessed by an independent review committee using established response criteria. The study seeks to demonstrate that tisagenlecleucel provides superior outcomes compared to standard therapies.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with confirmed relapsed or refractory follicular lymphoma after multiple lines of therapy.

Not a fit: Patients with grade 3B follicular lymphoma or those who have previously received anti-CD19 therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve progression-free survival for patients with relapsed follicular lymphoma.

How similar studies have performed: Previous studies have shown promising results with CAR-T therapies in hematologic malignancies, indicating potential success for this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Cincinnati, Ohio and 34 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Follicular Lymphomarelapsed or refractory follicular lymphomar/rFLCAR-TtisagenlecleucelCTL019phase III
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.