Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)NCT05645744
Long-term Follow-up Study in Patients Previously Treated With a Mustang Bio CAR-T Cell Investigational Product.
An observational study of Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) and Chronic Lymphocytic Leukemia in Relapse, run by Mustang Bio at 5 sites in United States.
Trial summary
A long-term follow-up study to assess safety and efficacy in patients previously treated with Mustang Bio chimeric antigen receptor (CAR)-T cell investigational products. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN), Chronic Lymphocytic Leukemia in Relapse, Small Lymphocytic Lymphoma, Relapsed
- What is being tested?
- Prior MB-102 CAR-T cell investigational product. and Prior MB-106 CAR-T cell investigational product.
- How many people
- 3 participants
- Where
- 5 sitesUnited States
- Study dates
- 29 Sep 2021to 12 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 previously treated with a Mustang Bio CAR-T cell investigational product in a Mustang Bio sponsored clinical study.
Who may be able to join
- Patients previously treated with a Mustang Bio CAR-T cell investigational product in a prior Mustang Bio sponsored clinical study.
- Patient has provided signed and dated informed consent.
Who cannot join
- None. All patients who have received prior treatment with Mustang Bio CAR-T cell investigational product in a Mustang Bio sponsored clinical study are eligible for this long-term follow up (LTFU) study.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Cleveland Clinic
Cleveland, Ohio, 44195
UC Irvine Health - Chao Family Comprehensive Cancer Center
Orange, California, 92868-3201
University of Rochester Medical Center
Rochester, New York, 14642
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
About this study
Official title: A Long-term Follow-up Study in Patients Previously Treated With Mustang Bio, Inc. CAR-T Cell Investigational Products
A long-term follow-up study to assess safety and efficacy in patients previously treated with Mustang Bio chimeric antigen receptor (CAR)-T cell investigational products.
Read the detailed description
Non-interventional, multi-center, long-term follow-up study of subjects previously treated with a Mustang Bio CAR-T cell investigational product in a Mustang Bio sponsored clinical study. Subjects who enroll will be monitored for a total of up to 15 years from the time of their last investigational product infusion.
- Conditions
- Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN), Chronic Lymphocytic Leukemia in Relapse, Small Lymphocytic Lymphoma, Relapsed, Waldenstrom's Macroglobulinemia Recurrent, Follicular B-cell Non-Hodgkin's Lymphoma, B-cell Lymphoma Refractory
- Being tested
- Prior MB-102 CAR-T cell investigational product., Prior MB-106 CAR-T cell investigational product.
- Keywords
- Long-term follow-up, CAR-T cell therapy, MB-102, MB-106
- Medical subject headings
- Blastic Plasmacytoid Dendritic Cell Neoplasm, Leukemia, Lymphocytic, Chronic, B-Cell, Recurrence, Leukemia, Hairy Cell, Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prior MB-102 CAR-T cell investigational product.Biological
No investigational product will be administered.
Prior MB-106 CAR-T cell investigational product.Biological
No investigational product will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Prior MB-102 CAR-T cell investigational product. | Patients previously treated with MB-102 CAR-T cell investigational product. Receives: Biological: Prior MB-102 CAR-T cell investigational product. | |
| Prior MB-106 CAR-T cell investigational product. | Patients previously treated with MB-106 CAR-T cell investigational product. Receives: Biological: Prior MB-106 CAR-T cell investigational product. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs)
Incidence and characterization of adverse events (AEs) related to prior treatment with a Mustang Bio CAR-T cell investigational product received in a Mustang Bio sponsored clinical study.
Measured: Up to a total of 15 years
Replication competent lentivirus (RCL)
Detection of replication competent lentivirus (RCL).
Measured: Up to a total of 15 years
Secondary outcomes (1)
Survival
Overall Survival.
Measured: Up to a total of 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start29 Sep 2021
- Primary completion12 Apr 2024
- Study completion12 Apr 2024
Why it stopped: Business Reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)Studies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mustang Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bruce Dezube, M.D., Study director, Mustang Bio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05645744
- Sponsor's protocol ID
- MB100-OBS-001
- Status last verified
- Jan 2024
- First submitted
- 1 Dec 2022
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-term Follow-up Study in Patients Previously Treated With Mustang Bio, Inc. CAR-T Cell Investigational Products
- ClinicalTrials.gov ID
- NCT05645744
- Acronym / sponsor ID
- MB100-OBS-001
- Conditions
- Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN), Chronic Lymphocytic Leukemia in Relapse, Small Lymphocytic Lymphoma, Relapsed, Waldenstrom's Macroglobulinemia Recurrent, Follicular B-cell Non-Hodgkin's Lymphoma, B-cell Lymphoma Refractory
- Keywords
- Long-term follow-up, CAR-T cell therapy, MB-102, MB-106
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Business Reasons
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Mustang BioIndustry (pharma, biotech, devices)
- Study start
- 29 Sep 2021 (actual)
- Primary completion
- 12 Apr 2024 (actual)
- Study completion
- 12 Apr 2024 (actual)
- First posted
- 9 Dec 2022 (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.
A long-term follow-up study to assess safety and efficacy in patients previously treated with Mustang Bio chimeric antigen receptor (CAR)-T cell investigational products.
Detailed description
Non-interventional, multi-center, long-term follow-up study of subjects previously treated with a Mustang Bio CAR-T cell investigational product in a Mustang Bio sponsored clinical study. Subjects who enroll will be monitored for a total of up to 15 years from the time of their last investigational product infusion.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prior MB-102 CAR-T cell investigational product. | – | Biological: Prior MB-102 CAR-T cell investigational product.Patients previously treated with MB-102 CAR-T cell investigational product. |
| Prior MB-106 CAR-T cell investigational product. | – | Biological: Prior MB-106 CAR-T cell investigational product.Patients previously treated with MB-106 CAR-T cell investigational product. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients previously treated with a Mustang Bio CAR-T cell investigational product in a Mustang Bio sponsored clinical study.
Key inclusion criteria (2 listed)
- Patients previously treated with a Mustang Bio CAR-T cell investigational product in a prior Mustang Bio sponsored clinical study.
- Patient has provided signed and dated informed consent.
Key exclusion criteria (1 listed)
- None. All patients who have received prior treatment with Mustang Bio CAR-T cell investigational product in a Mustang Bio sponsored clinical study are eligible for this long-term follow up (LTFU) study.
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 |
|---|---|---|
| Prior MB-102 CAR-T cell investigational product.No investigational product will be administered. | Biological | Prior MB-102 CAR-T cell investigational product. |
| Prior MB-106 CAR-T cell investigational product.No investigational product will be administered. | Biological | Prior MB-106 CAR-T cell investigational product. |
Primary outcome
Adverse events (AEs)
Time frame: Up to a total of 15 years
Incidence and characterization of adverse events (AEs) related to prior treatment with a Mustang Bio CAR-T cell investigational product received in a Mustang Bio sponsored clinical study.
Replication competent lentivirus (RCL)
Time frame: Up to a total of 15 years
Detection of replication competent lentivirus (RCL).
1 secondary outcome
Survival
Time frame: Up to a total of 15 years
Results and safety
The study was stopped early (reason given: Business Reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Bruce Dezube, M.D. study director
Mustang Bio
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) and Chronic Lymphocytic Leukemia in Relapse, run by Mustang Bio at 5 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: stopped early, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
The study was stopped early (reason given: Business Reasons). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (AEs) (time frame: Up to a total of 15 years). The study lists 2 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 22 Jul 2024.