Relmacabtagene Autoleucel in Hematologic Malignancies

Not yet recruiting

• Conditions: Lymphoma, B-Cell; Large B-cell Lymphoma; Follicular Lymphoma
• Interventions: Biological: Relmacabtagene Autoleucel

• Registration Number: NCT06142188
• Lead Sponsor: Shanghai Ming Ju Biotechnology Co., Ltd.

Brief Summary

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.

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-15
• Study First Submitted QC: 2023-11-15
• Last Update Submitted: 2023-11-15
• Study First Posted: 2023-11-21
• Last Update Posted: 2023-11-21
• Study Start: 2023-12-28
• Primary Completion: 2038-12-31
• Study Completion: 2038-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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 If previously enrolled in another clinical study, they must have completed follow-up in the previous study, or have withdrawn or lost follow-up in the previous study.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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Relmacabtagene Autoleucel	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.

Primary Outcome Measures

Name	Time	Method
ORR	15 years	Percentage of participants with CR \[CMR;CRR\] or PR \[partial metabolic response (PMR);

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China

Peking University International Hospital; 🇨🇳 Beijing, Beijing, China