Non Hodgkin LymphomaNCT06116110
Lentiviral Gene Therapy (Zamtocabtagene Autoleucel) LTFU
An observational study of Non Hodgkin Lymphoma and Refractory Diffuse Large B Cell Lymphoma (DLBCL), run by Miltenyi Biomedicine GmbH at 11 sites in United States.
Trial summary
This is an observational long-term follow-up (LTFU) study for subjects who previously received zamtocabtagene autoleucel, known as MB-CART2019.1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Hodgkin Lymphoma, Refractory Diffuse Large B Cell Lymphoma (DLBCL), Relapsed Diffuse Large B Cell Lymphoma
- What is being tested?
- Long-term Follow-Up
- How many people
- 150 participants
- Where
- 11 sitesUnited States
- Study dates
- 15 May 2024to 1 Dec 2041
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have received MB-CART2019.1
Who may be able to join
- Received zamtocabtagene autoleucel in a North American Miltenyi Biomedicine-sponsored clinical study and have not withdrawn consent to be followed or been deemed lost to follow-up.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.
Who cannot join
- None
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
United States11 sites, 11 recruiting
- Not yet recruiting
University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, 21201
Nancy Hardy, MD, nhardy1@umm.edu
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Christopher Simmons, Christopher_Simmons@DFCI.HARVARD.EDU
- Recruiting
Robert H Lurie Cancer Center
Chicago, Illinois, 60611
Chiena Whitt, chiena.whitt@northwestern.edu
Reem Karmali, MD
- Recruiting
UT Southwestern Medical Center
Dallas, Texas, 75390
Farrukh Awan, MD, Farrukh.awan@utsouthwestern.edu
- Recruiting
Duke University Medical Center - Division of Hematologic Malignancies
Durham, North Carolina, 27705
Matthew McKinney, MD, Matthew.mckinney@duke.edu
- Recruiting
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
Yasmin Adam, Yasmin.Adam2@bannerhealth.com
- Recruiting
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Hailey McArthey, hmcarthey@mcw.edu
- Recruiting
Yale University
New Haven, Connecticut, 06520
Jialing Zhang, jialing.zhang@yale.edu
- Recruiting
Oregon Health and Science University Knight Cancer Institute
Portland, Oregon, 97239
Richard Maziarz, MD, maziarzr@ohsu.edu
- Recruiting
Stanford University
Stanford, California, 94305
Christina Tran, ctran13@stanford.edu
- Recruiting
University of Kansas Cancer Center
Westwood, Kansas, 66205
Sunil Abhyankar, MD, sabhyankar@kumc.edu
About this study
Official title: A Prospective, Observational, Long-term Follow-up Study for Subjects Who Previously Received Zamtocabtagene Autoleucel in a North American Miltenyi Biomedicine-Sponsored Clinical Study
This is an observational long-term follow-up (LTFU) study for subjects who previously received zamtocabtagene autoleucel, known as MB-CART2019.1.
Read the detailed description
This is a non-therapeutic study design. After successful screening, subjects will be monitored for potential gene therapy-related adverse events for up to 15 years post MB-CART2019.1 infusion. Subjects will be assessed yearly for the occurrence of delayed adverse events (AEs), monitored for replication competent lentivirus (RCL) and assessed for long term efficacy as well as CAR-T persistence.
- 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, Primary Mediastinal B-cell Lymphoma (PMBCL)
- Being tested
- Long-term Follow-Up
- Keywords
- Chimeric antigen receptor, CAR T, CD19, CD20
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long-term Follow-UpOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Long-term Follow-Up | No intervention Receives: Other: Long-term Follow-Up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with new or recurrence of pre-existing malignancy
Measured: Up to 15 years
Number of subjects with new incidence or exacerbation of a pre-existing neurological disorder
Measured: Up to 15 years
Number of subjects with new incidence or exacerbation of pre-existing rheumatologic or other autoimmune disorders
Measured: Up to 15 years
Number of subjects with new incidence of Grade ≥ 3 hematologic disorders
Measured: Up to 15 years
Number of subjects with related AEs, related SAEs, and all AESIs
AESIs will be collected
Measured: Up to 15 years
Secondary outcomes (6)
Number of subjects with measurable replication competent lentivirus in peripheral blood (if positive at study entry)
Peripheral blood samples may be collected for RCL assessment
Measured: Up to 15 years
Duration of zamtocabtagene autoleucel persistence
Peripheral blood samples will be collected to test for CAR T cells
Measured: Up to 15 years
Objective Response Rate (ORR)
ORR for subjects who did not have progressive disease at their last assessment in the parent study; will be assessed by IRC and Investigator using Lugano 2014 Criteria for DLBCL and SCNSL and using IPCG Criteria (Abrey 2005) for PCNSL
Measured: Up to 15 years
Overall Survival
OS, measured from the date of zamtocabtagene autoleucel infusion to the date of the subject's death or the date the subject is last to known to be alive
Measured: Up to 15 years
To determine the number of subjects who relapse after zamtocabtagene autoleucel infusion during LTFU
Disease relapse: Number of subjects who enter the study as responders and relapse
Measured: Up to 15 years
To assess immune reconstitution based on the recovery of total lymphocytes
Change from baseline in peripheral B cell and lymphocyte levels
Measured: Up to 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start15 May 2024
- Primary completion1 Dec 2041 (estimated)
- Study completion1 Dec 2041 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by Miltenyi Biomedicine GmbHThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Miltenyi Biomedicine GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Remi Kaleta, MD, Study director, Miltenyi Biomedicine GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06116110
- Sponsor's protocol ID
- M-2023-401
- Status last verified
- Aug 2026
- First submitted
- 30 Oct 2023
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational, Long-term Follow-up Study for Subjects Who Previously Received Zamtocabtagene Autoleucel in a North American Miltenyi Biomedicine-Sponsored Clinical Study
- ClinicalTrials.gov ID
- NCT06116110
- Acronym / sponsor ID
- M-2023-401
- 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, Primary Mediastinal B-cell Lymphoma (PMBCL)
- Keywords
- Chimeric antigen receptor, CAR T, CD19, CD20
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Miltenyi Biomedicine GmbHIndustry (pharma, biotech, devices)
- Study start
- 15 May 2024 (actual)
- Primary completion
- 1 Dec 2041 (estimated)
- Study completion
- 1 Dec 2041 (estimated)
- First posted
- 3 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an observational long-term follow-up (LTFU) study for subjects who previously received zamtocabtagene autoleucel, known as MB-CART2019.1.
Detailed description
This is a non-therapeutic study design. After successful screening, subjects will be monitored for potential gene therapy-related adverse events for up to 15 years post MB-CART2019.1 infusion. Subjects will be assessed yearly for the occurrence of delayed adverse events (AEs), monitored for replication competent lentivirus (RCL) and assessed for long term efficacy as well as CAR-T persistence.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Long-term Follow-Up | – | Other: Long-term Follow-UpNo intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have received MB-CART2019.1
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Long-term Follow-UpNo intervention | Other | Long-term Follow-Up |
Primary outcome
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
AESIs will be collected
6 secondary outcomes
Number of subjects with measurable replication competent lentivirus in peripheral blood (if positive at study entry)
Time frame: Up to 15 years
Duration of zamtocabtagene autoleucel persistence
Time frame: Up to 15 years
Objective Response Rate (ORR)
Time frame: Up to 15 years
Overall Survival
Time frame: Up to 15 years
To determine the number of subjects who relapse after zamtocabtagene autoleucel infusion during LTFU
Time frame: Up to 15 years
To assess immune reconstitution based on the recovery of total lymphocytes
Time frame: Up to 15 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Remi Kaleta, MD study director
Miltenyi Biomedicine GmbH
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Hodgkin Lymphoma and Refractory Diffuse Large B Cell Lymphoma (DLBCL), run by Miltenyi Biomedicine GmbH at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sadie Swift (617-218-0044, clinicaltrials@miltenyi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with new or recurrence of pre-existing malignancy (time frame: Up to 15 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.