Relmacabtagene Autoleucel in Hematologic Malignancies

November 15, 2023 updated by: Shanghai Ming Ju Biotechnology Co., Ltd.

A Real-world Study for the Treatment of Hematologic Malignancies With Relmacabtagene Autoleucel

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100010
        • Beijing Cancer Hospital
        • Contact:
          • Yuqing Song, PhD
      • Beijing, Beijing, China, 100010
        • Peking University International Hospital
        • Contact:
          • Xinjian Liu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Hematologic Malignancies

Description

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 If previously enrolled in another clinical study, they must have completed follow-up in the previous study, or have withdrawn or lost follow-up in the previous study.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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Biological: Relmacabtagene Autoleucel
A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells
Other Names:
  • JWCAR029

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: 15 years
Percentage of participants with CR [CMR;CRR] or PR [partial metabolic response (PMR);
15 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CRR
Time Frame: 15 years
Complete response rate
15 years
Duration of response (DOR)
Time Frame: 15 years
Time from first response(PR or CR) to disease progression or death from any cause.
15 years
Progression-Free Survival (PFS)
Time Frame: 15 years
PFS is defined as the time from the Relmacabtagene Autoleucel infusion date to the date of disease progression per Lugano classification or death from any cause.
15 years
Overall Survival (OS)
Time Frame: 15 years
OS is defined as the time from Relmacabtagene Autoleucel infusion to the date of death from any cause.
15 years
Adverse events (AEs)
Time Frame: 15 years
Types, frequency, and severity of adverse events and laboratory anomalies Physiological parameter
15 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Ming Ju Biotechnology Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 28, 2023

Primary Completion (Estimated)

December 31, 2038

Study Completion (Estimated)

December 31, 2038

Study Registration Dates

First Submitted

November 15, 2023

First Submitted That Met QC Criteria

November 15, 2023

First Posted (Estimated)

November 21, 2023

Study Record Updates

Last Update Posted (Estimated)

November 21, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JWCAR029418

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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