Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a phase II, open-label, single-arm, multicenter study to assess the efficacy and safety of JWCAR029 in adult R/R Mantle Cell Lymphoma subjects in China.
This is a phase II, open-label, single-arm, multicenter study conducted in adult subjects with relapsed and refractory (R/R) mantle cell lymphoma (MCL) in China to evaluate the safety, efficacy, pharmacokinetics(PK), pharmacodynamics(PD) of JWCAR029 and immune response after JWCAR029 treatment.
R/R MCL patients will be enrolled in dose level of 1.0 x 10^8 CAR+ T cells. All subjects will be followed for 5 years following JWCAR029 infusion.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JWCAR029 treatment | Experimental | JWCAR029 be administrated at dose level: 1 x 10^8 CAR+T cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD19-targeted Chimeric Antigen Receptor (CAR) T Cells | Biological | JWCAR029 will be administered at dose level: 1 x 10^8 CAR+T cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | Objective response rate (ORR) in 3 month in relapsed and refractory (R/R) mantle cell lymphoma (MCL) subjects | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response rate (CRR) | Complete response rate (CRR) in 3 month in relapsed and refractory (R/R) mantle cell lymphoma (MCL) subjects | 3 months |
| The best objective response rate | The best objective response rate in 3 month in relapsed and refractory (R/R) mantle cell lymphoma (MCL) subjects |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Cancer Hospital | Beijing | Beijing Municipality | 100000 | China | ||
| Peking University Third Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40811825 | Derived | Xie Y, Zhou KS, Li LF, Liang AB, Mei H, Zou DH, Li WY, Jin J, Jin ZM, Jing HM, Yang HY, Chen T, Huang HQ, He PC, Cao JN, Xia Z, Gu YE, Zang YB, Zhou ZS, Tian ZZ, Zhu J, Song YQ. Phase 2 study of relmacabtagene autoleucel (CD19 CAR-T) for relapsed/refractory mantle cell lymphoma in Chinese adults. Blood Adv. 2026 Feb 24;10(4):1134-1144. doi: 10.1182/bloodadvances.2024015763. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 3 months |
| The best complete response rate | The best complete response rate in 3 month in relapsed and refractory (R/R) mantle cell lymphoma (MCL) subjects | 3 months |
| Number of participants with adverse events (AEs) | Number of participants with adverse events | Up to 24 months after JWCAR029 infusion |
| Type of adverse events (AEs) | Type of adverse events | Up to 24 months after JWCAR029 infusion |
| Severity of adverse events(AEs) | Severity of adverse events | Up to 24 months after JWCAR029 infusion |
| Number of participants with laboratory abnormalities | Number of participants with laboratory abnormalities | Up to 24 months after JWCAR029 infusion |
| Type of laboratory abnormalities | Type of laboratory abnormalities | Up to 24 months after JWCAR029 infusion |
| Severity of laboratory abnormalities | 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 complete response (CR) or partial response (PR) | Up to 24 months after JWCAR029 infusion |
| Time to complete response (TTCR) | Time from JWCAR029 infusion to first documentation of complete response (CR) | Up to 24 months after JWCAR029 infusion |
| Cmax of JWCAR029 | Maximum observed concentration of JWCAR029 in peripheral blood | Up to 1 year after JWCAR029 infusion |
| Tmax of JWCAR029: | Time to maximum concentration of JWCAR029 in the peripheral blood | Up to 1 year after JWCAR029 infusion |
| AUC of JWCAR029: | Area under the concentration vs time curve of JWCAR029 in the peripheral blood | Up to 1 year after JWCAR029 infusion |
| Progression-free survival (PFS) | Progression-free survival | Up to 2 year after JWCAR029 infusion |
| Overall survival (OS) | Overall survival | Up to 5 year after JWCAR029 infusion |
| Anti-therapeutic JWCAR029 antibody | Anti-therapeutic JWCAR029 antibody | Up to 2 year after JWCAR029 infusion |
| Changes of T cell counts | Changes of T cell counts | Up to 2 year after JWCAR029 infusion |
| Changes of Subgroups of T cell | Changes of Subgroups of T cell | Up to 2 year after JWCAR029 infusion |
| Changes of serum cytokines | Changes of serum cytokines | Up to 2 year after JWCAR029 infusion |
| CD19 expression in tumor biopsy samples | CD19 expression in tumor biopsy samples | Up to 2 year after JWCAR029 infusion |
| Changes in inflammatory biomarkers such as CRP | Changes in inflammatory biomarkers such as CRP | Up to 2 year after JWCAR029 infusion |
| Changes in inflammatory biomarkers such as ferritin | Changes in inflammatory biomarkers such as CRP | Up to 2 year after JWCAR029 infusion |
| Beijing |
| Beijing Municipality |
| China |
| Fujian Medical University Consonancy Hospital | Fuzhou | Fujiang | China |
| Guangdong Province people hospital | Guanzhou | Guangdong | China |
| Henan Province Cancer Hospital | Zhengzhou | Henan | China |
| Jiangsu Province People Hospital | Nanjing | Jiangsu | China |
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | China |
| Zhongshan Hospital affiliated to Fudan University | Shanghai | Shanghai Municipality | China |
| Institute of Hematology, Chinese Academy of Medical Sciences | Tianjin | Tianjin Municipality | China |
| Tianjin Cancer Hospital | Tianjin | Tianjin Municipality | China |
| The First Affiliated Hospital of Zhejiang University | Hangzhou | Zhejiang | China |
| Zhejiang province Cancer Hospital | Hangzhou | Zhejiang | China |
| ID | Term |
|---|---|
| D020522 | Lymphoma, Mantle-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| 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 |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D001336 | Automobiles |
| ID | Term |
|---|---|
| D018986 | Motor Vehicles |
| D014186 | Transportation |
| D013676 | Technology, Industry, and Agriculture |
Not provided
Not provided