Lentiviral Gene Therapy (Zamtocabtagene Autoleucel) LTFU | NCT06116110

Studies
Lentiviral Gene Therapy (Zamtocabtagene Autoleucel) LTFU

NCT06116110

Sponsor

Miltenyi Biomedicine GmbH

Status

Recruiting

Last Update Posted

Nov 20, 2024Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Non Hodgkin Lymphoma

Interventions

Long-term Follow-Up

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 15, 2024Actual

Primary Completion Date

Dec 1, 2039Estimated

Completion Date

Dec 1, 2039Estimated

First Submitted Date

Oct 30, 2023

First Submission Date that Met QC Criteria

Oct 30, 2023

First Posted Date

Nov 3, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 18, 2024

Last Update Posted Date

Nov 20, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Long-term Follow-Up		No intervention	Other: Long-term Follow-Up

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Long-term Follow-Up	Other	No intervention	Long-term Follow-Up

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The incidence of serious and non serious adverse events of special interest	AESIs will be collected	Up to 15 years

Secondary Outcomes

Measure	Description	Time Frame
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	Up to 15 years
Duration of zamtocabtagene autoleucel persistence

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Received zamtocabtagene autoleucel in a Miltenyi Biomedicine-sponsored clinical study and have either completed the study or have discontinued early from the study.
Provided written informed consent to participate in this study.

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients who have received MB-CART2019.1

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sadie Swift	Contact	617-218-0044		clinicaltrials@miltenyi.com
Paris Jamiel	Contact	617-218-0044		clinicaltrials@miltenyi.com

Overall Officials

Name	Affiliation	Role
Remi Kaleta, MD	Miltenyi Biomedicine GmbH	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University	Recruiting	Stanford	California	94305	United States

Condition Browse Module

MeSH Terms

ID	Term
D008228	Lymphoma, Non-Hodgkin

Ancestor Terms

ID	Term
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders

Browse Leaves

Not provided

Browse Branches

Not provided