Testing Gene-modified (GM) T cell therapy for neoplasms
Official title: Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells
Long-Term Follow-up Protocol for Subjects Treated With Gene-Modified T Cells
- Phase 2
- 1 group
- Sites in Calgary, Vancouver and 3 more cities
- Recruiting
Interventions
- Genetic therapy
Gene-modified (GM) T cell therapy
No investigational product will be administered
Canadian Sites (5)
3 of 5 recruiting
- Recruiting
University Of Calgary
Calgary, Alberta
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario
- Recruiting
CIUSSS de l'Est-de-l'Ile-de-Montreal
Montreal, Quebec
- Withdrawn
Local Institution - 02802
Vancouver, British Columbia
- Withdrawn
Local Institution - 02801
Hamilton, Ontario
Eligibility Criteria
See who this study is looking for4 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Received at least one gene-modified (GM) T-cell infusion in a previous Celgene sponsored, Juno Therapeutics, other affiliates of BMS, or Celgene alliance partner-sponsored trial, and have discontinued, or completed the post-treatment follow-up periodFollow-upContinued check-ins after the treatment part is finished.Read more → in the parent treatment protocolProtocolThe detailed plan a study must follow.Read more →, as applicable.
- +Must understand and voluntarily sign an Informed Consent FormInformed consentThe process of being told what taking part involves, then choosing freely.Read more →/Informed Assent Form prior to any study-related assessments/procedures being conducted.
Exclusion
- −Not Applicable
- −Other protocolProtocolThe detailed plan a study must follow.Read more →-defined inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more →/exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → apply
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study does not fall into the standard research categories.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more →/3 — a combined study that runs the middle stage and the large comparison stage together.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
Everyone in this study is in one group and receives Gene-modified (GM) T cell therapy.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
There is only one group in this study, so there is no assignment to different treatments.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 1,541 people.
The study is currently expected to finish around November 2036.
The main measurement is taken over: Up to 15 years from last gene-modified (GM) T cell infusion.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Incidence of delayed Adverse EventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → (AEs) — measured over Up to 15 years from last gene-modified (GM) T cell infusion.
Persistence of GM T cell drug products — measured over Up to 15 years from last GM T cell infusion.
Analysis of vector integration sites — measured over Up to 15 years from last GM T cell infusion.
Incidence of replication-competent lentiviruses — measured over Up to 15 years from last GM T cell infusion.
The study lists 4 further main measurements.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT03435796 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Gene-modified (GM) T cell therapyGenetic
No investigational product will be administered
From the trial registry — its own words, unedited.
What a genetic is here: A gene-based treatment — such as gene transfer or gene editing — being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
There is only one group in this study, so there is no assignment to different treatments.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Up to 15 years from last gene-modified (GM) T cell infusion.
The study as a whole is currently expected to finish around 2036-11-30.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 1,541 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 16 locations, including: Calgary, Alberta, Canada; Vancouver, British Columbia, Canada; Hamilton, Ontario, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada; Ann Arbor, Michigan, United States, and 10 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
This is a prospective study for the long-term follow-up (LTFU) of safety and efficacy for all pediatric and adult participants exposed to Gene-modified (GM) T-cell therapy participating in a previous Celgene sponsored or Celgene alliance partner sponsored study. Participants who received at least one infusion of GM T cells will be asked to enroll in this LTFU protocol upon either premature discontinuation from, or completion of the prior parent treatment protocol.
Other Sites (18)
University Of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Karmanos Cancer Center Wayne State University
Detroit, Michigan, United States
Local Institution - 01056
Southfield, Michigan, United States
M Health Fairview University of Minnesota Medical Center - East Bank
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
New York Oncology Hematology P.C.
Albany, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Local Institution - 01066
New York, New York, United States
New York University - Langone Medical Center - The Center for Musculoskeletal Care
New York, New York, United States
Weill Cornell Medicine / New York Presbyterian Hospital
New York, New York, United States
Icahn School Of Medicine At Mount Sinai
New York, New York, United States
Columbia University Medical Center/New York-Presbyterian Hospital
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Local Institution - 01051
Rochester, New York, United States
Swedish Cancer Institute
Seattle, Washington, United States
Local Institution - 01060
Seattle, Washington, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Local Institution - 01055
Tacoma, Washington, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.