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Using cema-cel to treat patients with large B-cell lymphoma who have minimal residual disease after first-line therapy

A Randomized, Open-label Study Evaluating the Efficacy and Safety of Cemacabtagene Ansegedleucel in Participants With Minimal Residual Disease After Response to First Line Therapy for Large B-cell Lymphoma

Phase 2 Interventional Allogene Therapeutics · NCT06500273

This study is testing if a new CAR T-cell therapy called cema-cel can help adults with large B-cell lymphoma who still have some cancer left after their first treatment feel better compared to just being monitored.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment250 (estimated)
Ages18 Years and up
SexAll
SponsorAllogene Therapeutics Industry-sponsored
Drugs / interventionsradiation, CAR T, cyclophosphamide, fludarabine
Locations64 sites (Gilbert, Arizona and 63 other locations)
Trial IDNCT06500273 on ClinicalTrials.gov

What this trial studies

This clinical trial is a randomized, open-label study designed for adult patients with large B-cell lymphoma (LBCL) who have completed standard first-line therapy and have either a complete or partial response but still show minimal residual disease (MRD). Participants will be randomized to receive either the allogeneic CAR T-cell therapy cemacabtagene ansegedleucel (cema-cel) or standard observation. The study aims to evaluate the efficacy and safety of cema-cel compared to observation, utilizing the Foresight CLARITY™ MRD test to identify eligible patients. The trial consists of two parts, with continuous enrollment and a focus on optimizing lymphodepletion regimens prior to treatment.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with histologically confirmed LBCL who have completed first-line therapy and have a positive MRD test.

Not a fit: Patients with central nervous system involvement or those who have received additional lines of therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for patients with LBCL who have minimal residual disease after initial therapy.

How similar studies have performed: Other studies utilizing CAR T-cell therapies have shown promising results, indicating that this approach may be effective for similar patient populations.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

1. LBCL per WHO 2017 including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, and primary mediastinal B-cell lymphoma histologically confirmed by pathology report.
2. Participant has completed a full course of standard first line therapy (e.g., R-CHOP, dose-adjusted EPOCH-R, Pola-R-CHP) as intended. Participants cannot have received additional lines of therapy.
3. Participant achieved CR, or PR suitable for observation, at the end of first line therapy based on PET/CT evaluation
4. Foresight CLARITY™ IUO MRD test, powered by PhasED-Seq™, is positive.
5. Adult participants ≥18 years of age.
6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
7. Adequate hematological, renal, hepatic, pulmonary, and cardiac function
8. Non-hematologic toxicities related to prior therapy must be recovered to baseline or grade ≤1.

Key Exclusion Criteria:

1. LBCL with history of central nervous system involvement, transformed from other malignancy (e.g., transformed follicular lymphoma or marginal zone lymphoma, Richter's transformation), or T-cell/histiocyte rich LBCL.
2. Prior treatment with anti-CD19 targeted therapies.
3. Anti-cancer treatment, including radiation, after end of treatment PET/CT and/or MRD testing is performed.
4. Active and clinically significant autoimmune disease.
5. Active systemic bacterial, fungal, or viral infections requiring systemic treatment.
6. History of another primary malignancy or bone marrow disorder (e.g., myelofibrosis, smoldering multiple myeloma) within 3 years prior to enrollment.

Where this trial is running

Gilbert, Arizona and 63 other locations

+14 more sites — see ClinicalTrials.gov for the full list.

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 Large B-cell LymphomaDiffuse large B-cell lymphomaDLBCLPrimary mediastinal B-cell lymphomaLBCLHigh grade B-cell lymphomaHGBCLDouble-hit lymphoma
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.