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Not yet recruiting NCT06142188

Relmacabtagene Autoleucel in Hematologic Malignancies

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Relmacabtagene Autoleucel.
Who it may be relevant to
Registry conditions: Lymphoma, B-Cell, Large B-cell Lymphoma, Follicular Lymphoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

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.

Interventions

  • Biological Relmacabtagene Autoleucel
    A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells

Primary outcome measures

  • ORR [Time frame: 15 years]
Secondary outcome measures (5)
  • CRR [Time frame: 15 years]
  • Duration of response (DOR) [Time frame: 15 years]
  • Progression-Free Survival (PFS) [Time frame: 15 years]
  • Overall Survival (OS) [Time frame: 15 years]
  • Adverse events (AEs) [Time frame: 15 years]

Eligibility criteria

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 • If previously enrolled in another clinical study, they must have completed follow-up in the previous study, or have withdrawn or lost follow-up in the previous study.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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

China · 2 centers
  • Beijing Cancer Hospital — Beijing
  • Peking University International Hospital — Beijing

Identifiers

NCT: NCT06142188 · JWCAR029418

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗