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The primary objective of this study is to asess the efficacy of Relmacabtagene autoleucel as second-line therapy in adult patients with aggressive B-cell Non-Hodgkins Lymphoma who are ineligible for haematopoietic stem cell transplantation.
This is an open-label, multicenter, Phase 2 study to determine the antitumor activity, PK, and safety of JWCAR029(Relmacabtagene autoleucel ) in subjects who have relapsed within 12 months from, or are refractory to, a single line of immunochemotherapy for aggressive Bcell NHL and are ineligible for HSCT (as defined in the eligibility criteria). Subjects will be treated with lymphodepleting chemotherapy and JWCAR029.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Relmacabtagene Autoleucel | Experimental | Experimental: Relmacabtagene Autoleucel Participants will receive cyclophosphamide250 mg/m^2/day intravenously (IV) and fludarabine 25 mg/m^2/day IV conditioning chemotherapy for 3 days followed by 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 at 3 month | Percentage of participants with CR [CMR;CRR] or PR [partial metabolic response (PMR);](streamdown:incomplete-link) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| CRR at 3 month | Complete response rate in subjects at 3 month | 3 months |
| 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:
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| Name | Affiliation | Role |
|---|---|---|
| Weili Zhao, PhD | Ruijin Hospital | Principal Investigator |
| Depei Wu, PhD | The First Affiliated Hospital of Soochow University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Hospital | Guangzhou | Guangdong | China | |||
| Henan Cancer Hospital |
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| Fludarabine | Drug | Administered according to package insert |
|
| Cyclophosphamide | Drug | Administered according to package insert |
|
| up to 2 years after Relmacabtagene Autoleucel infusion |
| Duration of complete remission (DoCR) | Time from complete response (CR) to disease progression or death from any cause. | up to 2 years after Relmacabtagene Autoleucel infusion |
| Duration of partial remission (DoPR) | Time from partial response (PR) to disease progression or death from any cause. | up to 2 years after Relmacabtagene Autoleucel infusion |
| Time to response (TTR) | Time from JWCAR029 infusion to first documentation of CR or PR | up to 2 years after Relmacabtagene Autoleucel infusion |
| 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. | up to 2 years after Relmacabtagene Autoleucel infusion |
| Overall Survival (OS) | OS is defined as the time from Relmacabtagene Autoleucel infusion to the date of death from any cause. | up to 2 year after Relmacabtagene Autoleucel infusion |
| Adverse events (AEs) | Types, frequency, and severity of adverse events and laboratory anomalies Physiological parameter | up to 2 year after Relmacabtagene Autoleucel infusion |
| Pharmacokinetic (PK)- Cmax of Relmacabtagene Autoleucel | Maximum observed concentration of Relmacabtagene Autoleucel in peripheral blood | up to 1 year after Relmacabtagene Autoleucel infusion |
| Pharmacokinetic (PK)- Tmax of Relmacabtagene Autoleucel | Time to maximum concentration of Relmacabtagene Autoleucel in peripheral blood | up to 1 year after Relmacabtagene Autoleucel infusion |
| Pharmacokinetic (PK)- AUC of Relmacabtagene Autoleucel | Area under the concentration vs time curve of Relmacabtagene Autoleucel | up to 1 year after Relmacabtagene Autoleucel infusion |
| The concentration of Car-T cell | The concentration of Car-T cell in peripheral blood | up to 1 year after Relmacabtagene Autoleucel infusion |
| Zhengzhou |
| Henan |
| China |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | China |
| Hunan Cancer Hospital | Changsha | Hunan | China |
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215006 | China |
| Shandong Cancer Hospital | Jinan | Shandong | China |
| Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, | Shanghai | Shanghai Municipality | 200025 | China |
| Institute of Hematology&Hospital of Blood Disease CAMS | Tianjin | Tianjin Municipality | 300000 | China |
| Tianjin Cancer Hospital | Tianjin | Tianjin Municipality | China |
| The First Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | China |
| Beijing Tongren Hospital | Beijing | China |
| Peking Union Medical College Hospital | Beijing | China |
| Jiangsu Provincial People's Hospital | Nanjing | China |
| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000718412 | relmacabtagene autoleucel |
| C024352 | fludarabine |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
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