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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: Recruiting Phase 2 study of Central Nervous System Lymphoma and Mantle Cell Lymphoma (MCL), sponsored by Miltenyi Biomedicine.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

ORR

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

FieldValue
Enrollment Target 248 participants
Start Date 2021-05-25
Est. Completion 2028-12-31
Phase Phase 2
Miltenyi Biomedicine

3 total trials

What NCT04792489 shows while recruiting

NCT04792489 is an interventional study that assigns participants to a tested intervention. The registered 248 participants enrollment target is mid-sized for trials with a published cap, above the 88-participant average among 14 other Central Nervous System Lymphoma trials with a reported enrollment target (182% higher).

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 names 20 study sites across 17 states, led by 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.

Similar trials for Central Nervous System Lymphoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04792489's enrollment target sits among peer trials

248 2nd of 14 the highest of 14 other Central Nervous System Lymphoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Central Nervous System Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04792489, the US trial registry maintained by the National Library of Medicine. NCT04792489 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.