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This is a phase II, open-label, single-arm, multicenter study to asess the efficacy and safety of JWCAR029 in adult R/R Non-Hodgkins Lymphoma subjects in China.
This is a phase II, open-label, single-arm, multicenter study conducted in adult subjects with R/R Non-Hodgkins Lymphoma in China to evaluate the safety, efficacy, pharmacokinetics(PK), pharmacodynamics(PD) of JWCAR029 and collect the patient reported quality of life changes and immune response after JWCAR029 treatment.
There will be two cohorts of cohort A and cohort B. Large B cell lymphoma (LBCL) patients will be enrolled in cohort A and follicular lymphoma patients will be enrolled in cohort B. Two dose levels of 1.0 x 10^8 CAR+ T cells and 1.5 x 10^8 CAR+ T cells are adopted in this study in both cohorts, subjects will be randomly assigned into the two dose levels with a 1:1 ratio. All sujects will be followed for 2 years following JWCAR029 infusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JWCAR029 treatment | Experimental | JWCAR029 be administrated in two dose level |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD19-targeted Chimeric Antigen Receptor (CAR) T Cells | Biological | JWCAR029 be administered at dose level: 1 x 10^8 CAR+T cells and 1.5 x 10^8 CAR+T cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) in LBCL subjects in cohort A; | Objective response rate (ORR) in 3 month in cohort A of large B cell lymphoma (LBCL) subjectsï¼› | 3 months |
| Complete response rate (CRR) in FL subjects in cohort B | Complete response rate (CRR) in 3 month in cohort B of follicular lymphoma (FL) subjects | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response rate (CRR) in cohort A of LBCL subjects | 3 months | |
| Objective response rate (ORR) in cohort B of FL subjects | 3 months | |
| Adverse events (AEs) |
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Inclusion Criteria:
Subjects must meet all of the following criteria to participate in the study:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yuqin Song | Peking University Cancer Hospital & Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | China | |||
| Beijing Friendship Hospital, Capital Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33382529 | Result | Ying Z, Yang H, Guo Y, Li W, Zou D, Zhou D, Wang Z, Zhang M, Wu J, Liu H, Zhang P, Yang S, Zhou Z, Zheng H, Song Y, Zhu J. Relmacabtagene autoleucel (relma-cel) CD19 CAR-T therapy for adults with heavily pretreated relapsed/refractory large B-cell lymphoma in China. Cancer Med. 2021 Feb;10(3):999-1011. doi: 10.1002/cam4.3686. Epub 2020 Dec 31. | |
| 40888120 |
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Number of participants with adverse events, type of adverse events, severity of adverse events, and number of participants with laboratory abnormalities, type of laboratory abnormalities and severity of laboratory abnormalities. |
| up to 24 months after JWCAR029 infusion |
| Duration of response (DOR) | Time from first response(PR or CR) to disease progression or death from any cause. | up to 24 months after JWCAR029 infusion |
| Duration of complete remission (DoCR) | Time from complete response (CR) to disease progression or death from any cause. | up to 24 months after JWCAR029 infusion |
| Duration of partial remission (DoPR) | Time from partial response (PR) to disease progression or death from any cause. | up to 24 months after JWCAR029 infusion |
| Time to response (TTR) | Time from JWCAR029 infusion to first documentation of CR or PR | up to 24 months after JWCAR029 infusion |
| Time to complete response (TTCR) | Time from JWCAR029 infusion to first documentation of CR | up to 24 months after JWCAR029 infusion |
| Pharmacokinetic (PK)- Cmax of JWCAR029 | Maximum observed concentration of JWCAR029 in peripheral blood | up to 1 year after JWCAR029 infusion |
| Pharmacokinetic (PK)- Tmax of JWCAR029 | Time to maximum concentration of JWCAR029 in the peripheral blood | up to 1 year after JWCAR029 infusion |
| Pharmacokinetic (PK)- AUC of JWCAR029 | Area under the concentration vs time curve of JWCAR029 | up to 1 year after JWCAR029 infusion |
| Progression-free survival (PFS) | 3 to 5 years after JWCAR029 infusion |
| Overall survival | 3 to 5 years after JWCAR029 infusion |
| Quality of Life C30 questionnaire (EORTC-QLQ-C30) | EORTC-QLQ-C30 is composed of both multi-item scales and single item measures. These include five functional scales (physical, role, emotional, cognitive and social), three symptom scales (fatigue, nausea/vomiting, and pain), a global health status/health-related quality of life (HRQoL) scale, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Each of the multi-item scales includes a different set of items - no item occurs in more than one scale | up to 2 year after JWCAR029 infusion |
| European Quality of Life-5 Dimensions health state classifier to 5 Levels (EQ-5D-5L) | The EQ-5D-5L consists of the EQ-5D-5L descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels (no problems, slight problems, moderate problems, severe problems, extreme problems) | up to 2 year after JWCAR029 infusion |
| ICU and non-ICU hospitalization days | up to 2 year after JWCAR029 infusion |
| ICU and non-ICU hospitalization reasons | up to 2 year after JWCAR029 infusion |
| Anti-therapeutic JWCAR029 antibody | up to 2 year after JWCAR029 infusion |
| Changes of T cell counts, subgroups and serum cytokines | up to 2 year after JWCAR029 infusion |
| CD19 expression in tumor biopsy samples | up to 2 year after JWCAR029 infusion |
| Changes of inflammation biomarkers-CRP | up to 1 year after JWCAR029 infusion |
| Changes of inflammation biomarkers-serum ferritin | up to 1 year after JWCAR029 infusion |
| Beijing |
| Beijing Municipality |
| China |
| Beijing Hospital | Beijing | Beijing Municipality | China |
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | China |
| Guangdong General Hospital | Guangzhou | Guangdong | China |
| The First Affiliated Hospital of Zhenzhou Universtity | Zhenzhou | Henan | China |
| Jiangsu Cancer Hospital | Nanjing | Jiangsu | China |
| Shanghai East Hospital | Shanghai | Shanghai Municipality | China |
| Institute of Hematology&Hospital of Blood Disease CAMS | Tianjin | Tianjin Municipality | China |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | China |
| Song Y, Zou D, Yang H, Wu J, Guo Y, Li W, Liu H, Xia Z, Zhang Y, Zhou Z, Zhu J. Two-year follow-up of relmacabtagene autoleucel in relapsed or refractory follicular lymphoma in RELIANCE study. Br J Haematol. 2025 Oct;207(4):1476-1483. doi: 10.1111/bjh.20122. Epub 2025 Sep 1. |
| 36842849 | Derived | Ying Z, Yang H, Guo Y, Li W, Zou D, Zhou D, Wang Z, Zhang M, Wu J, Liu H, Wang C, Ma L, Yang S, Zhou Z, Qin Y, Song Y, Zhu J. Long-term outcomes of relmacabtagene autoleucel in Chinese patients with relapsed/refractory large B-cell lymphoma: Updated results of the RELIANCE study. Cytotherapy. 2023 May;25(5):521-529. doi: 10.1016/j.jcyt.2022.10.011. Epub 2023 Feb 24. |
| 36053875 | Derived | Ying Z, Zou D, Yang H, Wu J, Guo Y, Li W, Liu H, Wang C, Ma L, Yang S, Zhou Z, Qin Y, Song Y, Zhu J. Preliminary efficacy and safety of Relmacabtagene autoleucel (Carteyva) in adults with relapsed/refractory follicular lymphoma in China: A phase I/II clinical trial. Am J Hematol. 2022 Dec;97(12):E436-E438. doi: 10.1002/ajh.26711. Epub 2022 Sep 14. No abstract available. |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008224 | Lymphoma, Follicular |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| 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 |
| D016393 | Lymphoma, B-Cell |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001336 | Automobiles |
| ID | Term |
|---|---|
| D018986 | Motor Vehicles |
| D014186 | Transportation |
| D013676 | Technology, Industry, and Agriculture |
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