DALY II USA/ MB-CART2019.1 for DLBCL

Part of paid clinical trials in Birmingham, Alabama.

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
Transplant-ineligible 2nd Line DLBCL

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 B cell lymphoma (BCL). Cohorts include subjects with diffuse large B-cell lymphoma (DLBCL) after receiving at least 2 lines of therapy, primary or secondary central nervous system (CNS) lymphoma (PCNSL) and (SCNSL) after receiving at least one line of therapy, mantle cell lymphoma (MCL) and Richter's transformation (RT) after receiving at least one line of therapy, and DLBCL transplant-ineligible after receiving at least one line of therapy.

Key Dates

First listed: Mar 11, 2021
Start date: May 25, 2021
Status verified: Jul 2026
Primary completion: Dec 31, 2026
Completion: Dec 31, 2028

Study Design

Enrollment: 315 participants (estimated)
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Arms

Experimental: Single, open label

Primary Outcome Measure

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

Central Contacts

Ron Gomez
617-218-0044
[email protected]
Harshita Gahankari
617-218-0044
[email protected]

Locations (30)

Facility	City	State	ZIP	Site coordinators
University of Alabama at Birmingham	Birmingham	Alabama	35233	Antwain Johnson [email protected]
Banner MD Anderson Cancer Center	Gilbert	Arizona	85234	Yasmin Adam [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]
Colorado Blood Cancer Institute	Denver	Colorado	80218	Luke Mountjoy, MD [email protected]
Yale University	New Haven	Connecticut	06520	Jialing Zhang [email protected]
Baptist Health Miami Cancer Institute	Miami	Florida	33176	Sueanna Sukie [email protected]
Winship Cancer Institute of Emory University	Atlanta	Georgia	30322	Amelia Langston, 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]
Washington University, St. Louis	St Louis	Missouri	63110	Amanda Cashen, 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	John Lister, MD [email protected]
University of Pittsburgh - Hillman Cancer Center	Pittsburgh	Pennsylvania	15260	-
SCRI Oncology Partners	Nashville	Tennessee	37203	Krish Patel, MD [email protected]
UT Southwestern Medical Center	Dallas	Texas	75390	Farrukh Awan, MD [email protected]
The University of Texas MD Anderson Cancer Center	Houston	Texas	77030	Luhua (Michael) Wang, MD [email protected]
Texas Transplant Institute	San Antonio	Texas	98109	Timothy Fenske, MD [email protected]
Fred Hutchinson Cancer Center	Seattle	Washington	98109	Jordan Gauthier, 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

University of Alabama at Birmingham· Birmingham, AL Banner MD Anderson Cancer Center· Gilbert, AZ Mayo Clinic· Phoenix, AZ UC San Diego Health· La Jolla, CA Stanford University· Stanford, CA Colorado Blood Cancer Institute· Denver, CO

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