Relmacabtagene Autoleucel in Hematologic Malignancies

NCT ID: NCT06142188

Last Updated: 2023-11-21

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

NOT_YET_RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-28

Study Completion Date

2038-12-31

Brief Summary

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

To evaluate the efficacy and safety of Relmacabtagene Autoleucel in the treatment of adult patients with hematologic malignancies in real-world

Detailed Description

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

The purpose of this study is to observationally evaluate the efficacy and safety data of Relmacabtagene Autoleucel for the treatment of patients with hematologic malignancies for up to 15 years after infusion. The treating physician will determine the most appropriate diagnostic and therapeutic regimen for the patient based on clinical practice. No therapeutic intervention will be administered to patients in this study.

Conditions

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

Lymphoma, B-Cell Large B-cell Lymphoma Follicular Lymphoma

Study Design

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

Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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

Relmacabtagene Autoleucel

Relmacabtagene Autoleucel administered as a single IV infusion at a target dose of 1 x 10\^8 anti-cluster of differentiation (CD)19 chimeric antigen receptor (CAR) transduced autologous T cells on Day1.

Relmacabtagene Autoleucel

Intervention Type BIOLOGICAL

A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells

Interventions

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

Relmacabtagene Autoleucel

A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells

Intervention Type BIOLOGICAL

Other Intervention Names

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

JWCAR029

Eligibility Criteria

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

Inclusion Criteria

1. Signed informed consent
2. Patients who have been treated with Relma-cel, including those who have received off-label products;
3. If previously enrolled in another clinical study, they must have completed follow-up in the previous study, or have withdrawn or lost follow-up in the previous study.

Exclusion Criteria

1.Patients who have been treated with Relma-cel and then have been treated with other CAR-T products.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

Shanghai Ming Ju Biotechnology Co., Ltd.

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.

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status

Peking University International Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yuqing Song, PhD

Role: CONTACT

+86 010-88121122

Medical JWCAR029

Role: CONTACT

+86 21 50464201

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Yuqing Song, PhD

Role: primary

Xinjian Liu

Role: primary

Other Identifiers

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

JWCAR029418

Identifier Type: -

Identifier Source: org_study_id