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Clinical Trials in China / NCT04718883
Active, not recruiting Phase 2

CD19-targeted CAR T Cells for Relapsed and Refractory (R/R) Mantle Cell Lymphoma

NCT04718883 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Ming Ju Biotechnology Co., Ltd.
Phase
Phase 2
Started
2021-01-13
Last updated
2023-11-24

Condition(s) studied

Mantle Cell Lymphoma

Investigational drug(s) / intervention(s)

CD19-targeted Chimeric Antigen Receptor (CAR) T Cells

CD19-targeted Chimeric Antigen Receptor (CAR) T Cells: JWCAR029 will be administered at dose level: 1 x 10\^8 CAR+T cells

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * ≥ 18 years old; * Sign on the informed consent; * Subject must have histologically confirmed mantle cell lymphoma; * Relapsed/refractory patients; * Subjects have accessible PET-positive lesion and have measurable CT-positive lesion according to Lugano Classification; * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; * Expected survival is greater than 12 weeks; * Adequate organ function; * Adequate vascular access for leukapheresis procedure; * Subjects who have previously received CD19 targeted therapy must confirm that lymphoma lesions still express CD19; * Women of childbearing potential must agree to use highly effective methods of contraception for 1 year after the last dose of JWCAR029; * Males who have partners of childbearing potential must agree to use an effective barrier contraceptive method for 1 year after the last dose of JWCAR029. Exclusion Criteria: * Central nervous system (CNS) only involvement by malignancy or primary CNS lymphoma; * History of another primary malignancy that has not been in remission for at least 2 years; * Subjects has HBV, HCV, HIV or syphilis infection at the time of screening; * Deep venous thrombosis (DVT)/Pulmonary embolism (PE), or DVT/PE requires anti-coagulation within 3 months prior to signing the ICF; * Subjects with uncontrolled systemic fungal, bacterial, viral or other infection; * Presence of acute or chronic graft-versus-host disease (GVHD); * History of any serious cardiovascular disease or presence of clinically relevant CNS pathology; * Pregnant or nursing women; * Subjects using of any chemotherapy, corticosteriod, experiment agents, GVHD therapies, radiation or any other therapies for lymphoma must go through a specific wash-out period before leukapheresis; * Received allo-hematopoietic stem cell transplantation therapy previously. * Uncontrolled conditions or unwillingness or inability to follow the procedures required in the protocol; * Received CAR T-cell or other genetically-modified T-cell therapy previously.

Primary outcome measure(s)

Trial sites (12)

FacilityCityRegionStatus
Peking University Cancer Hospital Beijing Beijing Municipality
Peking University Third Hospital Beijing Beijing Municipality
Fujian Medical University Consonancy Hospital Fuzhou Fujiang
Guangdong Province people hospital Guanzhou Guangdong
Henan Province Cancer Hospital Zhengzhou Henan
Jiangsu Province People Hospital Nanjing Jiangsu
Fudan University Shanghai Cancer Center Shanghai Shanghai Municipality
Zhongshan Hospital affiliated to Fudan University Shanghai Shanghai Municipality
Institute of Hematology, Chinese Academy of Medical Sciences Tianjin Tianjin Municipality
Tianjin Cancer Hospital Tianjin Tianjin Municipality
The First Affiliated Hospital of Zhejiang University Hangzhou Zhejiang
Zhejiang province Cancer Hospital Hangzhou Zhejiang

More Shanghai Ming Ju Biotechnology Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04718883 on ClinicalTrials.gov ↗ ← All trials in China