Recruiting

Phase 2

Phase 3

Gene-Modified T CellsLong-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells

Sponsor:

Celgene

Code:

NCT03435796

Conditions

Neoplasms

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Gene-modified (GM) T cell therapy

Study Details

Brief summary:

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.

Conditions

Neoplasms

Study ID

NCT03435796

Start date

Jul 19, 2018

Status verified date

Sep, 2026

Completion date

Nov 30, 2036

Anticipated

Primary completion date

Nov 30, 2036

Anticipated

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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 period in the parent treatment protocol, as applicable.
Must understand and voluntarily sign an Informed Consent Form/Informed Assent Form prior to any study-related assessments/procedures being conducted.

Exclusion Criteria:

Not Applicable

Other protocol-defined inclusion/exclusion criteria apply

Study Design

Enrollment

1541 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Participants exposed to Gene-modified (GM) T cell therapy

Interventions

Gene-modified (GM) T cell therapy

No investigational product will be administered

Primary outcome measure

Incidence of delayed Adverse Events (AEs) [ Time Frame: Up to 15 years from last gene-modified (GM) T cell infusion ]
Persistence of GM T cell drug products [ Time Frame: Up to 15 years from last GM T cell infusion ]
Analysis of vector integration sites [ Time Frame: Up to 15 years from last GM T cell infusion ]
Incidence of replication-competent lentiviruses [ Time Frame: Up to 15 years from last GM T cell infusion ]
Physical growth as assessed by physical examination (pediatric participants only) [ Time Frame: Up to 15 years from last GM T cells infusion or until Tanner Stage 5 is reached ]
Incidence of sexual maturation as assessed by the Tanner staging system (pediatric participants only) [ Time Frame: Up to 15 years from last GM T cells infusion or until Tanner Stage 5 ]
Proportion of participants who progressed on the study: participants with original diagnosis of malignancies [ Time Frame: Up to 15 years from last GM T cells infusion ]
Overall Survival (participants with original diagnosis of malignancies) [ Time Frame: Up to 15 years from last GM T cells infusion ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286 Clinical.Trials@bms.com

Locations

University of Alabama Birmingham

Recruiting

Birmingham, Alabama, United States, 10016

Contacts

Luciano Costa, Site 01171

205-934-9695

Banner MD Anderson Cancer Center

Recruiting

Gilbert, Arizona, United States, 85234

Contacts

Rajneesh Nath, Site 01049

480-256-3223

Mayo Clinic Phoenix

Recruiting

Phoenix, Arizona, United States, 85054

City Of Hope

Recruiting

Duarte, California, United States, 91010

Contacts

Tanya Siddiqi, Site 01011

626-256-4673

University Of California San Diego Moores Cancer Center

Recruiting

La Jolla, California, United States, 92093

Contacts

Thomas Kipps, Site 01019

858-822-6135

University of California, San Francisco- California

Recruiting

San Francisco, California, United States, 94143

Contacts

Charalambos Andreadis, Site 01108

415-238-1909

UCLA Medical Centre-Santa Monica

Recruiting

Santa Monica, California, United States, 90095

Contacts

Sarah Larson, Site 01184

310-829-5471

Stanford Cancer Center

Recruiting

Stanford, California, United States, 94305

Contacts

Michaela Liedtke, Site 01119

650-498-6000

University Of Colorado Cancer Center

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Manali Kamdar, Site 01208

720-848-0752

Colorado Blood Cancer Institute

Recruiting

Denver, Colorado, United States, 80218

Contacts

Tara Gregory, Site 01212

720-754-4800

Yale Cancer Center

Recruiting

New Haven, Connecticut, United States, 06520

Contacts

Iris Isufi, Site 01059

203-688-4242

The Mayo Clinic - Jacksonville, Davis-E

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Sikander Ailawadhi, Site 01201

904-953-0853

Sylvester Comprehensive Cancer Center, University of Miami Hospital and Clinics

Recruiting

Miami, Florida, United States, 33136

Contacts

Lazaros Lekakis, Site 01214

305-748-0641

Baptist Cancer Center

Recruiting

Miami, Florida, United States, 33176

Contacts

Yuliya Linhares, Site 01047

786-596-2000

USF Health Morsani Center for Advanced Healthcare

Recruiting

Tampa, Florida, United States, 33606

Contacts

Loutfi Succari, Site 01247

813-974-2681

H. Lee Moffitt Cancer Center and Research Institute University of South Florida

Recruiting

Tampa, Florida, United States, 33612

Contacts

Melissa Alsina, Site 01153

813-745-7202

Winship Cancer Institute of Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Sagar Lonial, Site 01103

404-778-1900

Northside Hospital, Inc

Recruiting

Atlanta, Georgia, United States, 30342

Contacts

Scott Solomon, Site 01207

404-255-1930

Northwestern Memorial Hospital

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Reem Karmali, Site 01014

312-695-0990

University Of Chicago Medical Center

Recruiting

Chicago, Illinois, United States, 60637-1447

Contacts

Peter Riedell, Site 01018

773-702-8412

IN Univ Simon Cancer Center

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Rafat Abonour, Site 01161

317-690-1577

Franciscan Health Indianapolis

Recruiting

Indianapolis, Indiana, United States, 46237

Contacts

Anand Tandra, Site 01217

317-871-0000

Kansas University Medical Center

Recruiting

Westwood, Kansas, United States, 66205

Contacts

Al-Ola Abdallah, Site 01174

918-261-6196

Cancer Center of Kansas

Recruiting

Wichita, Kansas, United States, 67214

Contacts

Bassam Mattar, Site 01031

316-262-4467

University Of Kentucky

Recruiting

Lexington, Kentucky, United States, 40536

Norton Cancer Institute Louisville Oncology

Recruiting

Louisville, Kentucky, United States, 40207

Contacts

Don Stevens, Site 01032

502-899-3366

University of Maryland - Greenebaum Comprehensive Cancer Center

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Mehmet Kocoglu, Site 01164

501-526-6990

Sidney Kimmel Comp Cancer Center at Johns Hopkins

Recruiting

Baltimore, Maryland, United States, 21231

Contacts

Syed Abbas Ali, Site 01017

443-287-7104

Massachusetts General Hospital / Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Jeremy Abramson, Site 01012

617-571-3037

University Of Michigan Comprehensive Cancer Center

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Monalisa Ghosh, Site 01024

734-936-4000

Karmanos Cancer Center Wayne State University

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Abhinav Deol, Site 01025

313-576-8093

M Health Fairview University of Minnesota Medical Center - East Bank

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Veronika Bachanova, Site 01112

612-625-5469

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Siteman Cancer Center

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Ravi Vij, Site 01176

314-409-4144

University Of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198-6840

Contacts

Matthew Lunning, Site 01015

402-559-7164

Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

David Siegel, Site 01102

201-996-5900

Morristown Memorial Hosp

Recruiting

Morristown, New Jersey, United States, 07962

Contacts

Mohamad Cherry, Site 01027

973-971-7906

New York Oncology Hematology P.C.

Recruiting

Albany, New York, United States, 12206

Roswell Park Cancer Institute

Recruiting

Buffalo, New York, United States, 14263

Contacts

Francisco Hernandez-Ilizaliturri, Site 01111

716-845-3099

New York University - Langone Medical Center - The Center for Musculoskeletal Care

Recruiting

New York, New York, United States, 10016

Contacts

Amit Saxena, Site 01070

646-501-7400

Weill Cornell Medicine / New York Presbyterian Hospital

Recruiting

New York, New York, United States, 10021

Contacts

Roger Niles Pearse, Site 01198

212-746-2956

Icahn School Of Medicine At Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Sundar Jagannath, Site 01109

212-241-7873

Columbia University Medical Center/New York-Presbyterian Hospital

Recruiting

New York, New York, United States, 10032

Contacts

Ran Reshef, Site 01209

212-342-0530

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Maria Palomba, Site 01177

212-639-7186

The University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Saira Sheikh, Site 01071

919-966-0545

Levine Cancer Institute

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Bei Hu, Site 01204

980-442-5231

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27705

Novant Health

Recruiting

Salisbury, North Carolina, United States, 28147

Contacts

Alan Skarbnik, Site 01058

347-266-6406

Oncology Hematology Care, Inc.

Recruiting

Cincinnati, Ohio, United States, 45242

Contacts

James Essell, Site 01037

513-686-5482

University Hospitals of Cleveland

Recruiting

Cleveland, Ohio, United States, 44106-5000

Contacts

Leland Metheny, Site 01042

216-844-0139

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Brian Hill, Site 01062

216-445-9451

Ohio State University Comprehensive Cancer Center (OSUCCC) - The James Cancer Hospital and Solove Research Institute

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Srinivas Devarakonda, Site 01074

570-423-0522

University of Oklahoma Peggy and Charles Stephenson Cancer Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Adam Asch, Site 01038

405-271-4022

Willamette Valley Cancer Institute

Recruiting

Eugene, Oregon, United States, 97401

Contacts

Jeff Sharman, Site 01052

541-683-5001

Providence Portland Medical Center

Recruiting

Portland, Oregon, United States, 97213

Contacts

Stacy Lewis, Site 01028

503-215-5696

Oregon Health and Science University OHSU

Recruiting

Portland, Oregon, United States, 97239

Contacts

Richard Maziarz, Site 01022

503-231-2498

University of Pennsylvania Perelman Center for Advanced Medicine

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Stephen Schuster, Site 01016

215-614-1846

Thomas Jefferson University - Clinical Research Institute

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Xia Bi, Site 01173

302-220-7456

Fox Chase Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19111

UPMC Cancer Pavillion

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Alison Sehgal, Site 01210

412-648-6579

Hematology and Oncology Associates of SC, LLC

Recruiting

Greenville, South Carolina, United States, 29615

Contacts

Saeeda Chowdhury, Site 01034

864-241-6252

Sarah Cannon Research Inst

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Jesus Berdeja, Site 01101

615-329-0570

Texas Oncology

Recruiting

Dallas, Texas, United States, 75230

Contacts

Jay Courtright, Site 01044

972-566-4291

Texas Oncology - Baylor Charles A. Sammons Cancer Center

Recruiting

Dallas, Texas, United States, 75246

Contacts

Houston Holmes, Site 01180

214-584-3402

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Larry Anderson, Site 01104

214-648-5906

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Maureen Mayes, Site 01215

713-500-6905

University of Texas- MD Anderson

Recruiting

Houston, Texas, United States, 77030

Contacts

Hun Lee, Site 01013

713-794-1829

Sam Clinical Research Center

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Paul Shaughnessy, Site 01211

210-670-2313

University of Utah - Huntsman Cancer Institute

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Douglas Sborov, Site 01199

801-585-0255

Intermountain Healthcare - LDS Hospital

Recruiting

Salt Lake City, Utah, United States, 84143

University Of Virginia Health System

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Indumathy Varadarajan, Site 01065

434-924-9333

Swedish Cancer Institute

Recruiting

Seattle, Washington, United States, 98104

Contacts

Daniel Egan, Site 01166

617-699-2437

Fred Hutchinson Cancer Center

Recruiting

Seattle, Washington, United States, 98109

Contacts

Jordan Gauthier, Site 01110

206-667-2713

University Of Wisconsin

Recruiting

Madison, Wisconsin, United States, 53705

Contacts

Natalie Callander, Site 01036

082658690

Froedtert Hospital BMT Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

University Of Calgary

Recruiting

Calgary, Alberta, Canada, T2N 2T9

Contacts

Nizar Bahlis, Site 02302

4039441880

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Christine Chen, Site 02301

4169464501

CIUSSS de l'Est-de-l'Ile-de-Montreal

Recruiting

Montreal, Quebec, Canada, H1T 2M4

More Information

Sponsor

Celgene

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Keywords

Long-term follow up
Gene-Modified T Cells
CAR T Cell

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Celgene on 2026-09-04.