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GM T Cell Therapy Long-Term Follow-Up for Cancer

Phase 2 & 3
Recruiting
Research Sponsored by Celgene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Received at least one gene-modified (GM) T-cell infusion in a previous Celgene sponsored or Celgene alliance partner-sponsored study, and have discontinued, or completed the post-treatment follow-up period in the parent treatment protocol, as applicable
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 years from last gm t cells infusion or until tanner stage 5
Awards & highlights

Study Summary

This trial will follow up on participants who received gene-modified T cell therapy in a previous study to see if the therapy is safe and effective in the long term.

Who is the study for?
This trial is for pediatric and adult patients who have previously received gene-modified (GM) T cell therapy in a Celgene sponsored or alliance partner study. Participants must have completed or discontinued the prior treatment protocol and be willing to sign an informed consent form.Check my eligibility
What is being tested?
The study focuses on long-term follow-up of safety and efficacy for those who underwent GM T cell therapy. It's designed to monitor participants after they've finished their initial treatment, tracking any long-term effects.See study design
What are the potential side effects?
Since this is a follow-up study, it will observe side effects from previous GM T cell therapy which may include immune reactions, infusion-related symptoms, and potential late-onset complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I've had a gene-modified T-cell infusion in a past Celgene study and completed the follow-up.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 15 years from last gm t cells infusion or until tanner stage 5
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 years from last gm t cells infusion or until tanner stage 5 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Analysis of vector integration sites
Disease Progression: Number of participants who continue to be responders, who have progressed, and who have relapsed will be reported.
Disease Relapse: Number of participants who continue to be responders, who have progressed, and who have relapsed will be reported.
+7 more
Secondary outcome measures
B-Lymphocytes

Trial Design

1Treatment groups
Experimental Treatment
Group I: Participants exposed to Gene-modified (GM) T cell therapyExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor
636 Previous Clinical Trials
128,537 Total Patients Enrolled
1 Trials studying Tumors
107 Patients Enrolled for Tumors
Claudia Schusterbauer, MDStudy DirectorCelgene Corporation
3 Previous Clinical Trials
247 Total Patients Enrolled
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,508 Previous Clinical Trials
3,370,106 Total Patients Enrolled
8 Trials studying Tumors
422 Patients Enrolled for Tumors

Media Library

Participants exposed to Gene-modified (GM) T cell therapy Clinical Trial Eligibility Overview. Trial Name: NCT03435796 — Phase 2 & 3
Tumors Research Study Groups: Participants exposed to Gene-modified (GM) T cell therapy
Tumors Clinical Trial 2023: Participants exposed to Gene-modified (GM) T cell therapy Highlights & Side Effects. Trial Name: NCT03435796 — Phase 2 & 3
Participants exposed to Gene-modified (GM) T cell therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT03435796 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many locations are conducting this trial?

"There are 4 main sites for this study: Levine Cancer Institute in North carolina, Thomas Jefferson University in Pennsylvania, and the University of Kentucky. In addition, there are smaller satellite enrolment centres in 99 other locations."

Answered by AI

How many study participants are there in total?

"A total of 317 patients are required for this trial, and fortunately various sites such as the Levine Cancer Institute in Charlotte, North carolina or Thomas Jefferson University in Philadelphia, Pennsylvania have fulfilled their patient quota."

Answered by AI

Is it possible to join this experiment now?

"Clinicaltrials.gov reports that this clinical trial is actively recruiting patients. The listing for the trial was first posted on June 19, 2018 and updated as recently as November 4, 2020."

Answered by AI

Who else is applying?

What site did they apply to?
Duke University Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells
2018. "Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03435796.
All > Bc Prostate Cancer > Oncology
~211 spots leftby Nov 2036
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