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NCT04718883 | Recruiting | Mantle Cell Lymphoma


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

Shanghai Ming Ju Biotechnology Co., Ltd.

Brief 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.

Condition or disease

Mantle Cell Lymphoma

Intervention/treatment

CD19-targeted Chimeric Antigen Receptor (CAR) T Cells

Phase

Phase 2

Detailed Description:

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 2 years following JWCAR029 infusion.

Study Type : Interventional
Estimated Enrollment : 59 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Open-Label, Single-Arm, Multicenter Study of JWCAR029, CD19-targeted Chimeric Antigen Receptor (CAR) T Cells for Relapsed and Refractory (R/R) Mantle Cell Lymphoma
Actual Study Start Date : January 13, 2021
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2025
Arm Intervention/treatment

Experimental: JWCAR029 treatment

JWCAR029 be administrated at dose level: 1 x 10^8 CAR+T cells

Biological: CD19-targeted Chimeric Antigen Receptor (CAR) T Cells

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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.

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Recruiting

China, Beijing

Peking University Cancer Hospital

Beijing, Beijing, China, 100000

Recruiting

China, Beijing

Peking University Third Hospital

Beijing, Beijing, China,

Recruiting

China, Fujiang

Fujian Medical University Consonancy Hospital

Fuzhou, Fujiang, China,

Recruiting

China, Guangdong

Guangdong Province people hospital

Guanzhou, Guangdong, China,

Recruiting

China, Henan

Henan Province Cancer Hospital

Zhengzhou, Henan, China,

Recruiting

China, Jiangsu

Jiangsu Province People Hospital

Nanjing, Jiangsu, China,

Recruiting

China, Shanghai

Fudan University Shanghai Cancer Center

Shanghai, Shanghai, China,

Recruiting

China, Shanghai

Zhongshan Hospital affiliated to Fudan University

Shanghai, Shanghai, China,

Recruiting

China, Tianjin

Institute of Hematology, Chinese Academy of Medical Sciences

Tianjin, Tianjin, China,

Recruiting

China, Tianjin

Tianjin Cancer Hospital

Tianjin, Tianjin, China,

Recruiting

China, Zhejiang

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China,

Recruiting

China, Zhejiang

Zhejiang province Cancer Hospital

Hangzhou, Zhejiang, China,

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