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Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCL
NCT06500273 · View on ClinicalTrials.gov ↗
Study Summary
This is a randomized, open-label study in adult patients who have completed standard first line therapy for large B-cell lymphoma (LBCL) and achieved a complete response or partial response suitable for observation, but who have minimal residual disease (MRD) as detected by the Foresight CLARITY™ Investigational Use Only (IUO) MRD test, powered by PhasED-Seq™. The purpose of the trial is to assess the efficacy and safety of consolidation with cemacabtagene ansegedleucel (cema-cel), an allogeneic CD19 CAR T product, as compared to standard of care observation. In this study, participants with MRD are randomized 1:1 to treatment with cema-cel or an observation arm. Treatment includes cema-cel following a lymphodepletion regimen of fludarabine and cyclophosphamide. Prior to August 2025, participants may also have received an anti-CD52 monoclonal antibody, ALLO-647, as part of their lymphodepletion regimen.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- GENETIC cemacabtagene ansegedleucel
- DEVICE Foresight CLARITY™ IUO MRD test, powered by PhasED-Seq™
Study Locations (20)
California
- Alta Bates Summit Medical Center — Berkeley
- City of Hope — Duarte
- Cedars-Sinai Medical Center — Los Angeles
- University of California, Los Angeles — Los Angeles
- University of California, Davis Comprehensive Cancer Center — Sacramento
- University of California, San Diego — San Diego
- University of California, San Francisco — San Francisco
Florida
- Miami Cancer Institute at Baptist Health, Inc. — Miami
- Advent Health Cancer Institute — Orlando
- Orlando Health Cancer Institute — Orlando
- Moffitt Cancer Center — Tampa
Arizona
- Banner MD Anderson Cancer Center — Gilbert
Arkansas
- Genesis Cancer and Blood Institute — Hot Springs
Colorado
- Rocky Mountain Cancer Centers — Denver
Delaware
- Medical Oncology Hematology Consultants — Newark
District of Columbia
- MedStar Georgetown University Hospital — Washington D.C.
Georgia
- Augusta University Georgia Cancer Center — Augusta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2024-06-18 |
| Est. Completion | 2032-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06500273
The ClinicalTrials.gov registry entry for NCT06500273 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Allogene Therapeutics, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Large B-cell Lymphoma appearing as the primary indexed condition, and to 4 interventions — of which Cyclophosphamide is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06500273 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06500273 about?
NCT06500273 is a clinical study titled "Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCL". This is a randomized, open-label study in adult patients who have completed standard first line therapy for large B-cell lymphoma (LBCL) and achieved a complete response or partial response suitable for observation, but who have minimal residual disease (MRD) as detected by the Foresight CLARITY™ In...
What is the current status of trial NCT06500273?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 250 participants. The study started on 2024-06-18. Estimated completion is 2032-12.
What conditions does trial NCT06500273 study?
This clinical trial studies the following conditions: Large B-cell Lymphoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06500273?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), cemacabtagene ansegedleucel (GENETIC), Foresight CLARITY™ IUO MRD test, powered by PhasED-Seq™ (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06500273?
This trial is sponsored by Allogene Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06500273 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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