DALY II USA/ MB-CART2019.1 for DLBCL

Part of paid clinical trials in Gilbert, Arizona.

Sponsor: Miltenyi Biomedicine GmbH
Study ID: NCT04792489
Phase: PHASE2
Status: Recruiting

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Conditions

Central Nervous System Lymphoma
High Grade B-cell Lymphoma (HGBCL)
Mantle Cell Lymphoma (MCL)
Primary Mediastinal B-cell Lymphoma (PMBCL)
Refractory Diffuse Large B Cell Lymphoma (DLBCL)
Relapsed Diffuse Large B Cell Lymphoma
Richter Transformation
Transformed Lymphoma

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

zamtocabtagene autoleucel (MB-CART2019.1) — BIOLOGICAL
Chimeric antigen receptor (CAR) T cell therapy
Cyclophosphamide — DRUG
Lymphodepleting chemotherapy
Fludarabine — DRUG
Lymphodepleting chemotherapy
Bendamustine — DRUG
Lymphodepleting chemotherapy

Study Details

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.

Key Dates

Start date: May 25, 2021
Status verified: Apr 2025
Primary completion: Dec 31, 2026
Completion: Dec 31, 2028

Study Design

Enrollment: 248 participants (estimated)
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Arms

Experimental: Single, open label

Primary Outcome Measure

Overall Response Rate [ Time Frame: through study completion, up to 2 years ]

Central Contacts

Bryan Dumont
617-218-0044
[email protected]
Harshita Gahankari
617-218-0044
[email protected]

Locations (23)

Facility	City	State	ZIP	Site coordinators
Banner MD Anderson Cancer Center	Gilbert	Arizona	85234	Amy Tolenada [email protected]
Mayo Clinic	Phoenix	Arizona	85054	Allison Rosenthal, DO [email protected]
UC San Diego Health	La Jolla	California	92037	Dimitrios Tzachanis, MD [email protected]
Stanford University	Stanford	California	94305	Christina Tran [email protected]
Yale University	New Haven	Connecticut	06520	Jialing Zhang [email protected]
Baptist Health Miami Cancer Institute	Miami	Florida	33176	Allison Rodriguez [email protected]
Winship Cancer Institute of Emory University	Atlanta	Georgia	30322	Jason Romancik, MD [email protected]
Georgia Cancer Center at Augusta University	Augusta	Georgia	30912	Vamsi Kota, MD [email protected]
Robert H Lurie Cancer Center	Chicago	Illinois	60611	Reem Karmali, MD [email protected]
University of Kansas Cancer Center	Westwood	Kansas	66205	Sunil Abhyankar, MD [email protected]
University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center	Baltimore	Maryland	21201	Nancy Hardy, MD [email protected]
Dana Farber Cancer Institute	Boston	Massachusetts	02215	Obed Posada Villanueva [email protected]
University of Michigan	Ann Arbor	Michigan	48109	Maria Hollobaugh [email protected]
Mayo Clinic	Rochester	Minnesota	55905	Patrick Johnston, MD [email protected]
University of Nebraska Medical Center	Omaha	Nebraska	68198	-
Memorial Sloan Kettering Cancer Center	New York	New York	10065	Miguel-Angel Perales, MD [email protected]
Duke University Medical Center - Division of Hematologic Malignancies	Durham	North Carolina	27705	Matthew S. McKinney, MD [email protected]
The Ohio State University Wexner Medical Center James Cancer	Columbus	Ohio	43210	Nathan Denlinger, DO [email protected]
Oregon Health and Science University Knight Cancer Institute	Portland	Oregon	97239	Richard Maziarz, MD [email protected]
Allegheny Health Network Cancer Institute	Pittsburgh	Pennsylvania	15212	Yazan Samhouri, MD [email protected]
University of Pittsburgh - Hillman Cancer Center	Pittsburgh	Pennsylvania	15260	-
UT Southwestern Medical Center	Dallas	Texas	75390	Farrukh Awan, MD [email protected]
Froedtert Hospital and the Medical College of Wisconsin	Milwaukee	Wisconsin	53226	Jessica Eisenhauer [email protected]

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By research site

Banner MD Anderson Cancer Center· Gilbert, AZ Mayo Clinic· Phoenix, AZ UC San Diego Health· La Jolla, CA Stanford University· Stanford, CA Yale University· New Haven, CT Baptist Health Miami Cancer Institute· Miami, FL

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