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To evaluate the efficacy and safety of Relmacabtagene Autoleucel in the treatment of adult patients with hematologic malignancies in real-world
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Relmacabtagene Autoleucel | Biological | A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Percentage of participants with CR [CMR;CRR] or PR [partial metabolic response (PMR);](streamdown:incomplete-link) | 15 years |
| Measure | Description | Time Frame |
|---|---|---|
| CRR | Complete response rate | 15 years |
| Duration of response (DOR) | Time from first response(PR or CR) to disease progression or death from any cause. |
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Inclusion Criteria:
Exclusion Criteria:
1.Patients who have been treated with Relma-cel and then have been treated with other CAR-T products.
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Hematologic Malignancies
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuqing Song, PhD | Contact | +86 010-88121122 | songyuqin622@163.com | |
| Medical JWCAR029 | Contact | +86 21 50464201 | JWCAR029Medical@jwtherapeutics.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100010 | China |
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| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000718412 | relmacabtagene autoleucel |
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| 15 years |
| 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 |
| Overall Survival (OS) | OS is defined as the time from Relmacabtagene Autoleucel infusion to the date of death from any cause. | 15 years |
| Adverse events (AEs) | Types, frequency, and severity of adverse events and laboratory anomalies Physiological parameter | 15 years |
| Peking University International Hospital | Beijing | Beijing Municipality | 100010 | China |
|
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |