Relmacabtagene Autoleucel in Hematologic Malignancies

Follicular Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06142188
• Other study ID #: JWCAR029418
• Status: Not yet recruiting
• Start date: December 28, 2023
• Est. completion date: December 31, 2038

Study information

• Verified date: November 2023
• Source: Shanghai Ming Ju Biotechnology Co., Ltd.
• Contact: Yuqing Song, PhD
• Phone: +86 010-88121122
• Email: songyuqin622[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 31, 2038
• Est. primary completion date: December 31, 2038
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 If previously enrolled in another clinical study, they must have completed follow-up in the previous study, or have withdrawn or lost follow-up in the previous study.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

Related Conditions & MeSH terms

• Follicular Lymphoma
• Hematologic Neoplasms
• Large B-cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell

Intervention

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

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	Peking University International Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Ming Ju Biotechnology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR	Percentage of participants with CR [CMR;CRR] or PR [partial metabolic response (PMR);	15 years
Secondary	CRR	Complete response rate	15 years
Secondary	Duration of response (DOR)	Time from first response(PR or CR) to disease progression or death from any cause.	15 years
Secondary	Progression-Free Survival (PFS)	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
Secondary	Overall Survival (OS)	OS is defined as the time from Relmacabtagene Autoleucel infusion to the date of death from any cause.	15 years
Secondary	Adverse events (AEs)	Types, frequency, and severity of adverse events and laboratory anomalies Physiological parameter	15 years