Recruiting

Zamtocabtagene Autoleucel

Sponsor:

Miltenyi Biomedicine GmbH

Code:

NCT06116110

Conditions

Non Hodgkin Lymphoma

Refractory Diffuse Large B Cell Lymphoma (DLBCL)

Relapsed Diffuse Large B Cell Lymphoma

High Grade B-cell Lymphoma

Central Nervous System Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Long-term Follow-Up

Study Details

Brief summary:

This is an observational long-term follow-up (LTFU) study for subjects who previously received zamtocabtagene autoleucel, known as MB-CART2019.1.

Conditions

Non Hodgkin Lymphoma

Refractory Diffuse Large B Cell Lymphoma (DLBCL)

Relapsed Diffuse Large B Cell Lymphoma

High Grade B-cell Lymphoma

Central Nervous System Lymphoma

Study ID

NCT06116110

Start date

May 15, 2024

Status verified date

Aug, 2026

Completion date

Dec 1, 2041

Anticipated

Primary completion date

Dec 1, 2041

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Received zamtocabtagene autoleucel in a North American Miltenyi Biomedicine-sponsored clinical study and have not withdrawn consent to be followed or been deemed lost to follow-up.
  • Provided written informed consent to participate in this study.

Exclusion Criteria:

  • None

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

Long-term Follow-Up

No intervention

Interventions

Long-term Follow-Up

No intervention

Primary outcome measure

  • Number of subjects with new or recurrence of pre-existing malignancy [ Time Frame: Up to 15 years ]
  • Number of subjects with new incidence or exacerbation of a pre-existing neurological disorder [ Time Frame: Up to 15 years ]
  • Number of subjects with new incidence or exacerbation of pre-existing rheumatologic or other autoimmune disorders [ Time Frame: Up to 15 years ]
  • Number of subjects with new incidence of Grade ≥ 3 hematologic disorders [ Time Frame: Up to 15 years ]
  • Number of subjects with related AEs, related SAEs, and all AESIs [ Time Frame: Up to 15 years ]

Central Contacts and Locations

Central contacts

Sadie Swift

617-218-0044clinicaltrials@miltenyi.com

Paris Jamiel

617-218-0044clinicaltrials@miltenyi.com

Locations

Banner MD Anderson Cancer Center

Recruiting

Gilbert, Arizona, United States, 85234

Contacts

Yasmin Adam

Yasmin.Adam2@bannerhealth.com

Stanford University

Recruiting

Stanford, California, United States, 94305

Contacts

Christina Tran

ctran13@stanford.edu

Yale University

Recruiting

New Haven, Connecticut, United States, 06520

Contacts

Jialing Zhang

jialing.zhang@yale.edu

Robert H Lurie Cancer Center

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Chiena Whitt

chiena.whitt@northwestern.edu

Principal Investigator:

Reem Karmali, MD

University of Kansas Cancer Center

Recruiting

Westwood, Kansas, United States, 66205

Contacts

Sunil Abhyankar, MD

sabhyankar@kumc.edu

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Christopher Simmons

Christopher_Simmons@DFCI.HARVARD.EDU

Duke University Medical Center - Division of Hematologic Malignancies

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Matthew McKinney, MD

Matthew.mckinney@duke.edu

Oregon Health and Science University Knight Cancer Institute

Recruiting

Portland, Oregon, United States, 97239

Contacts

Richard Maziarz, MD

maziarzr@ohsu.edu

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Farrukh Awan, MD

Farrukh.awan@utsouthwestern.edu

Froedtert Hospital and the Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Hailey McArthey

hmcarthey@mcw.edu

More Information

Sponsor

Miltenyi Biomedicine GmbH

Last update posted

Aug 5, 2026

Last verified

Aug, 2026

Keywords

  • Chimeric antigen receptor
  • CAR T
  • CD19
  • CD20

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Miltenyi Biomedicine GmbH on 2026-08-05.