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NCT Number: NCT06142188

Relmacabtagene Autoleucel in Hematologic Malignancies

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

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Key information

Conditions

Lymphoma, B-Cell Follicular Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Large B-cell Lymphoma Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Cancer Hospital, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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  • If previously enrolled in another clinical study, they must have completed follow-up in the previous study, or have withdrawn or lost follow-up in the previous study.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

Treatment and study plan

Relmacabtagene Autoleucel

Biological

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

Other names: JWCAR029

Primary outcomes

  1. ORR

    Time frame: 15 years

    Percentage of participants with CR [CMR;CRR] or PR [partial metabolic response (PMR);

Secondary outcomes

  1. CRR

    Time frame: 15 years

    Complete response rate

  2. Duration of response (DOR)

    Time frame: 15 years

    Time from first response(PR or CR) to disease progression or death from any cause.

  3. 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.

  4. 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.

  5. Adverse events (AEs)

    Time frame: 15 years

    Types, frequency, and severity of adverse events and laboratory anomalies Physiological parameter

Study contacts

Contact information is provided by the study sponsor or research team.

Medical JWCAR029

CONTACT

[email protected]

+86 21 50464201

Yuqing Song, PhD

CONTACT

[email protected]

+86 010-88121122

Sponsors and collaborators

Lead sponsor

Shanghai Ming Ju Biotechnology Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2038
Study completion
2038
First posted
Nov 21, 2023
Registry last updated
Nov 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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