NCT04718883

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P50-P75 for phase_2

Timeline
27mo left

Started Jan 2021

Longer than P75 for phase_2

Geographic Reach
1 country

12 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Jan 2021Aug 2028

Study Start

First participant enrolled

January 13, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 14, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2023

Completed
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 7, 2028

Expected
Last Updated

November 24, 2023

Status Verified

November 1, 2023

Enrollment Period

2.8 years

First QC Date

January 14, 2021

Last Update Submit

November 21, 2023

Conditions

Mantle Cell Lymphoma

Keywords

JWCAR029B-Cell MalignanciesNon-Hodgkin lymphomaCAR T cellsChimeric antigen receptorRelapsed/RefractoryMantle Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Objective response rate (ORR)

    Objective response rate (ORR) in 3 month in relapsed and refractory (R/R) mantle cell lymphoma (MCL) subjects

    3 months

Secondary Outcomes (26)

  • Complete response rate (CRR)

    3 months

  • The best objective response rate

    3 months

  • The best complete response rate

    3 months

  • Number of participants with adverse events (AEs)

    Up to 24 months after JWCAR029 infusion

  • Type of adverse events (AEs)

    Up to 24 months after JWCAR029 infusion

  • +21 more secondary outcomes

Study Arms (1)

JWCAR029 treatment

EXPERIMENTAL

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

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

Interventions

CD19-targeted Chimeric Antigen Receptor (CAR) T CellsBIOLOGICAL

JWCAR029 will be administered at dose level: 1 x 10\^8 CAR+T cells

JWCAR029 treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100000, China

Location

Peking University Third Hospital

Beijing, Beijing Municipality, China

Location

Fujian Medical University Consonancy Hospital

Fuzhou, Fujiang, China

Location

Guangdong Province people hospital

Guanzhou, Guangdong, China

Location

Henan Province Cancer Hospital

Zhengzhou, Henan, China

Location

Jiangsu Province People Hospital

Nanjing, Jiangsu, China

Location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Location

Zhongshan Hospital affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Location

Institute of Hematology, Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

Location

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, China

Location

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Location

Zhejiang province Cancer Hospital

Hangzhou, Zhejiang, China

Location

Related Publications (1)

  • Xie Y, Zhou K, Li L, Liang A, Mei H, Zou D, Li W, Jin J, Jin Z, Jing HM, Yang H, Chen T, Huang H, He P, Cao J, Zhu J, Song Y, Xia Z, Gu YE, Zang Y, Zhou Z, Tian ZZ. Phase 2 Study of Relmacabtagene Autoleucel (CD19 CAR-T) for Relapsed/Refractory Mantle Cell Lymphoma in Chinese Adults. Blood Adv. 2025 Aug 14:bloodadvances.2024015763. doi: 10.1182/bloodadvances.2024015763. Online ahead of print.

    PMID: 40811825DERIVED

MeSH Terms

Conditions

Lymphoma, Mantle-CellLymphoma, Non-HodgkinRecurrence

Interventions

Automobiles

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor VehiclesTransportationTechnology, Industry, and Agriculture

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2021

First Posted

January 22, 2021

Study Start

January 13, 2021

Primary Completion

October 25, 2023

Study Completion (Estimated)

August 7, 2028

Last Updated

November 24, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(12)