A Long-term Follow-up Study in Participants Who Received CTX001

NCT ID: NCT04208529

Last Updated: 2025-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE3

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-20

Study Completion Date

2039-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a multi-site, open- label rollover study to evaluate the long-term safety and efficacy of CTX001 in pediatric and adult participants who received CTX001 in parent studies 111 (NCT03655678) 141 (NCT05356195) or 161 (NCT05477563) (transfusion-dependent β-thalassemia \[TDT\] studies) or Study 121 (NCT03745287) or 151 (NCT05329649), 161(NCT05477563),171 (NCT05951205) (severe sickle cell disease \[SCD\] studies).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Beta-Thalassemia Thalassemia Sickle Cell Disease Hematologic Diseases Hemoglobinopathies Genetic Diseases, Inborn Sickle Cell Anemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Long Term Safety Follow-up
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CTX001

All participants who complete or discontinue one of the multiple parent studies (CTX001-111, CTX001-121, CTX001-141, CTX001-151, CTX001-161 and CTX001-171) after CTX001 infusion will be asked to participate in this long-term follow-up study.

Group Type EXPERIMENTAL

CTX001

Intervention Type BIOLOGICAL

CTX001 infusion.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CTX001

CTX001 infusion.

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Exagamglogene autotemcel Exa-cel

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Participants (or his or her legally appointed and authorized representative or guardian) must sign and date informed consent form (ICF) and, where applicable, an assent form
* Participants must have received CTX001 infusion in a parent study
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

CRISPR Therapeutics

INDUSTRY

Sponsor Role collaborator

Vertex Pharmaceuticals Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Lucile Packard Children's Hospital

Palo Alto, California, United States

Site Status

Ann & Robert H. Lurie Children's Hospital of Chicago - Hematology

Chicago, Illinois, United States

Site Status

Herbert Irving Pavilion - Hematology

New York, New York, United States

Site Status

New York Presbyterian Hospital - Morgan Stanley Children's Hospital

New York, New York, United States

Site Status

Levine Children's Hospital - Hematology

Charlotte, North Carolina, United States

Site Status

The Children's Hospital of Philadelphia - Hematology

Philadelphia, Pennsylvania, United States

Site Status

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Site Status

TriStar Medical Group Children's Specialists - Pediatric Oncology

Nashville, Tennessee, United States

Site Status

Methodist Healthcare System of San Antonio, Methodist Hospital, Methodist Children's Hospital

San Antonio, Texas, United States

Site Status

Hopital Universitaire des Enfants Reine Fabiola (HUDERF) - Hematology

Brussels, , Belgium

Site Status

Hospital for Sick Children - Hematology

Toronto, , Canada

Site Status

Toronto General Hospital - Hematology

Toronto, , Canada

Site Status

St. Paul's Hospital - Hematology

Vancouver, , Canada

Site Status

University Hospital Duesseldorf - Department of Pediatric Oncology, Hematology and Clinical Immunology

Düsseldorf, , Germany

Site Status

Center for Pediatric Clinical Studies (CPCS)

Klinik Für Kinder- Und Jugendmedizin, , Germany

Site Status

Regensburg University Hospital, Clinic and Polyclinic for Paediatric and Adolescent Medicine

Regensburg, , Germany

Site Status

IRCSS Ospedale Pediatrico Bambino Gesu - Dipartimento di Onco-Ematologia e Terapia Cellulare e Genica

Rome, , Italy

Site Status

Hammersmith Hospital - Haematology Dept

London, , United Kingdom

Site Status

University College London Hospital NHS Foundation - Main

London, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Belgium Canada Germany Italy United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

de la Fuente J, Frangoul H, Lang P, Wall D, Meisel R, Corbacioglu S, Li AM, Shah AJ, Carpenter B, Kwiatkowski JL, Mapara MY, Liem RI, Rupprecht J, Kuo KHM, Merkeley H, Algeri M, Smith W, Kohli P, Li N, Rubin J, Zhang S, Hobbs WE, Locatelli F. Improvements in Health-Related Quality of Life in Patients with Transfusion-Dependent beta-Thalassemia After Exagamglogene Autotemcel. Blood Adv. 2025 Aug 19:bloodadvances.2025016702. doi: 10.1182/bloodadvances.2025016702. Online ahead of print.

Reference Type DERIVED
PMID: 40862696 (View on PubMed)

Sharma A, Locatelli F, Bhatia M, Molinari L, Mapara MY, Liem RI, Dedeken L, Wall D, Eckrich MJ, Kuo KHM, Smith W, Imren S, Kohli P, Li N, Liu T, Rubin J, Hobbs WE, Grupp SA, Frangoul H. Improvements in Health-Related Quality of Life in Patients with Severe Sickle Cell Disease After Exagamglogene Autotemcel. Blood Adv. 2025 Aug 19:bloodadvances.2025016701. doi: 10.1182/bloodadvances.2025016701. Online ahead of print.

Reference Type DERIVED
PMID: 40857358 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2024-512654-19-00

Identifier Type: OTHER

Identifier Source: secondary_id

VX18-CTX001-131

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

CS-101 in Patients With β-thalassemia
NCT06328764 ENROLLING_BY_INVITATION EARLY_PHASE1
Clinical Study of BRL-101 in Severe SCD
NCT06300723 ENROLLING_BY_INVITATION NA
CS-206 in Patients With Sickle Cell Disease
NCT07000318 NOT_YET_RECRUITING EARLY_PHASE1