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NCT04792489 · ClinicalTrials.gov registry record · Phase 2
DALY II USA/ MB-CART2019.1 for DLBCL
A Phase 2 study of Central Nervous System Lymphoma and Mantle Cell Lymphoma (MCL), sponsored by Miltenyi Biomedicine.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 248
- Enrollment target
- 20
- Study locations
NCT04792489 is a Phase 2 study of Central Nervous System Lymphoma and Mantle Cell Lymphoma (MCL) that is actively recruiting participants, run by Miltenyi Biomedicine. The registered enrollment target is 248 participants, above the 88-participant average among 14 other Central Nervous System Lymphoma trials with a reported enrollment target (182% higher). The trial reports 20 study locations across 17 states.
The verdict
NCT04792489, a Phase 2 study of Central Nervous System Lymphoma and Mantle Cell Lymphoma (MCL), is actively recruiting participants, sponsored by Miltenyi Biomedicine.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 248 participants
- Enrollment target
- 20
- Study locations
Study Summary
DALY II USA is a phase II, multi-center, single arm study to evaluate the efficacy, safety, and pharmacokinetics of zamtocabtagene autoleucel (MB-CART2019.1) in patients with relapsed and/or refractory diffuse large B cell lymphoma (DLBCL) after receiving at least two lines of therapy. Additional cohorts include subjects with B-cell primary or secondary central nervous system (CNS) lymphoma (PCNSL) and (SCNSL), mantle cell lymphoma (MCL) and Richter's transformation (RT) after receiving at least one line of therapy.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Bendamustine
- BIOLOGICAL zamtocabtagene autoleucel (MB-CART2019.1)
Study Locations (20)
Arizona
- Banner MD Anderson Cancer Center - Gilbert
- Mayo Clinic - Phoenix
California
- UC San Diego Health - La Jolla
- Stanford University - Stanford
Georgia
- Winship Cancer Institute of Emory University - Atlanta
- Georgia Cancer Center at Augusta University - Augusta
Connecticut
- Yale University - New Haven
Florida
- Baptist Health Miami Cancer Institute - Miami
Illinois
- Robert H Lurie Cancer Center - Chicago
Kansas
- University of Kansas Cancer Center - Westwood
Maryland
- University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 248 participants |
| Start Date | 2021-05-25 |
| Est. Completion | 2028-12-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04792489
The ClinicalTrials.gov registry entry for NCT04792489 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 248 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 88-participant average among 14 other Central Nervous System Lymphoma trials with a reported enrollment target (182% higher). The listed sponsor is Miltenyi Biomedicine, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 8 conditions, with Central Nervous System Lymphoma appearing as the primary indexed condition, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT04792489 reports 20 study locations spanning 17 distinct geographic areas - top geographies include Arizona, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT04792489 about?
NCT04792489 is a clinical study titled "DALY II USA/ MB-CART2019.1 for DLBCL". DALY II USA is a phase II, multi-center, single arm study to evaluate the efficacy, safety, and pharmacokinetics of zamtocabtagene autoleucel (MB-CART2019.1) in patients with relapsed and/or refractory diffuse large B cell lymphoma (DLBCL) after receiving at least two lines of therapy. Additional co...
What is the current status of trial NCT04792489?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 248 participants. The study started on 2021-05-25. Estimated completion is 2028-12-31.
What conditions does trial NCT04792489 study?
This clinical trial studies the following conditions: Central Nervous System Lymphoma, Mantle Cell Lymphoma (MCL), Relapsed Diffuse Large B-cell Lymphoma, Transformed Lymphoma, High Grade B-cell Lymphoma (HGBCL).
What interventions are being tested in trial NCT04792489?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Bendamustine (DRUG), zamtocabtagene autoleucel (MB-CART2019.1) (BIOLOGICAL).
Who is sponsoring clinical trial NCT04792489?
This trial is sponsored by Miltenyi Biomedicine, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04792489 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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