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Relmacabtagene Autoleucel as Second-Line Therapy in Adult Patients With Aggressive B-cell NHL

Primary Purpose

Lymphoma, Large B-Cell, Diffuse, Follicular Lymphoma Grade 3B, High-grade B-cell Lymphoma

Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Relmacabtagene Autoleucel
Fludarabine
Cyclophosphamide
Sponsored by
Shanghai Ming Ju Biotechnology Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, Large B-Cell, Diffuse focused on measuring Relmacabtagene Autoleucel, aggressive B-cell non-Hodgkin lymphoma, Chimeric antigen receptor T cells, second-line

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age≥18 years; Signed written informed consent obtained prior to any study procedures; Histologically confirmed relapsed or refractory (R/R) aggressive B-cell NHL of the following histologiesLBCL as defined by the World Health Organization (WHO) Classification 2022:Diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), high-grade B-cell lymphoma (HGL) with MYC and BCL2 rearrangements,HGL-NOS, Primary mediastinal large B-cell lymphoma, Follicular lymphoma Grade 3B (FL3B),Indolent B-NHL-transformed large B-cell lymphoma with adequate prior treatment with anthracycline-containing agents and rituximab or other CD20-targeted agents; Subjects must meet the definition of refractory or relapsed; Subjects were not eligible for HDCT/ASCT based on the investigator's assessment ; Adequate organ function; Presence of positive PET assessable lesions as determined by the Lugano criteria ; Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; Expected survival greater than 12 weeks; Adequate vascular access for leukapheresis procedure; Women of childbearing potential must agree to use highly effective methods of contraception for at least 28 days prior to lymphocyte clearance chemotherapy through 2 year after Relmacabtagene Autoleucel infusion; Males who have partners of childbearing potential must agree to use an effective barrier contraceptive method for 2 year after Relmacabtagene Autoleucel infusion; Exclusion Criteria: Subjects with non-Hodgkin's lymphoma who have received second or more line therapy; Lymphoma of the primary center (subjects with secondary central nervous system lymphoma are allowed to enroll; History of another primary malignancy that has not been in remission for at least 2 years; Subjects has active 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; Uncontrolled diabetes and hypertension; Presence of acute or chronic graft-versus-host disease (GVHD); Active autoimmune disease requiring immunosuppressive therapy; History of any serious cardiovascular disease or presence of clinically relevant CNS pathology; Pregnant or nursing women; Subjects Received an autologous or allogeneic hematopoietic stem cell transplant; 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; Received live vaccination within 6 weeks prior to lymphocyte clearance chemotherapy; History of severe hypersensitivity reactions to any of the drug ingredients used in this study product.

Sites / Locations

  • Sun Yat-sen University Cancer Hospital
  • Henan Cancer Hospital
  • The First Affiliated Hospital of Zhengzhou University
  • Hunan Cancer Hospital
  • The First Affiliated Hospital of Soochow University
  • Shandong Cancer Hospital
  • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,
  • Institute of Hematology&Hospital of Blood Disease CAMS
  • Tianjin Cancer Hospital
  • The First Affiliated Hospital of Zhejiang University School of Medicine
  • Beijing Tongren Hospital
  • Peking Union Medical College Hospital
  • Jiangsu Provincial People's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Relmacabtagene Autoleucel

Arm Description

Experimental: Relmacabtagene Autoleucel Participants will receive cyclophosphamide250 mg/m^2/day intravenously (IV) and fludarabine 25 mg/m^2/day IV conditioning chemotherapy for 3 days followed by Relmacabtagene Autoleucel administered as a single IV infusion at a target dose of 1 x 10^8 anti-cluster of differentiation (CD)19 chimeric antigen receptor (CAR) transduced autologous T cells on Day1.

Outcomes

Primary Outcome Measures

ORR at 3 month
Percentage of participants with CR [CMR;CRR] or PR [partial metabolic response (PMR);

Secondary Outcome Measures

CRR at 3 month
Complete response rate in subjects at 3 month
Duration of response (DOR)
Time from first response(PR or CR) to disease progression or death from any cause.
Duration of complete remission (DoCR)
Time from complete response (CR) to disease progression or death from any cause.
Duration of partial remission (DoPR)
Time from partial response (PR) to disease progression or death from any cause.
Time to response (TTR)
Time from JWCAR029 infusion to first documentation of CR or PR
Progression-Free Survival (PFS)
PFS is defined as the time from the Relmacabtagene Autoleucel infusion date to the date of disease progression per Lugano classification or death from any cause.
Overall Survival (OS)
OS is defined as the time from Relmacabtagene Autoleucel infusion to the date of death from any cause.
Adverse events (AEs)
Types, frequency, and severity of adverse events and laboratory anomalies Physiological parameter
Pharmacokinetic (PK)- Cmax of Relmacabtagene Autoleucel
Maximum observed concentration of Relmacabtagene Autoleucel in peripheral blood
Pharmacokinetic (PK)- Tmax of Relmacabtagene Autoleucel
Time to maximum concentration of Relmacabtagene Autoleucel in peripheral blood
Pharmacokinetic (PK)- AUC of Relmacabtagene Autoleucel
Area under the concentration vs time curve of Relmacabtagene Autoleucel
The concentration of Car-T cell
The concentration of Car-T cell in peripheral blood

Full Information

First Posted
October 16, 2023
Last Updated
October 24, 2023
Sponsor
Shanghai Ming Ju Biotechnology Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT06093841
Brief Title
Relmacabtagene Autoleucel as Second-Line Therapy in Adult Patients With Aggressive B-cell NHL
Official Title
Relmacabtagene Autoleucel as Second-Line Therapy in Adult Patients With Aggressive B-cell NHL: a Single-arm, Multicenter, Open, Phase II Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
February 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Ming Ju Biotechnology Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of this study is to asess the efficacy of Relmacabtagene autoleucel as second-line therapy in adult patients with aggressive B-cell Non-Hodgkins Lymphoma who are ineligible for haematopoietic stem cell transplantation.
Detailed Description
This is an open-label, multicenter, Phase 2 study to determine the antitumor activity, PK, and safety of JWCAR029(Relmacabtagene autoleucel ) in subjects who have relapsed within 12 months from, or are refractory to, a single line of immunochemotherapy for aggressive Bcell NHL and are ineligible for HSCT (as defined in the eligibility criteria). Subjects will be treated with lymphodepleting chemotherapy and JWCAR029.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Large B-Cell, Diffuse, Follicular Lymphoma Grade 3B, High-grade B-cell Lymphoma, Mediastinal B-Cell Diffuse Large Cell Lymphoma
Keywords
Relmacabtagene Autoleucel, aggressive B-cell non-Hodgkin lymphoma, Chimeric antigen receptor T cells, second-line

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Relmacabtagene Autoleucel
Arm Type
Experimental
Arm Description
Experimental: Relmacabtagene Autoleucel Participants will receive cyclophosphamide250 mg/m^2/day intravenously (IV) and fludarabine 25 mg/m^2/day IV conditioning chemotherapy for 3 days followed by Relmacabtagene Autoleucel administered as a single IV infusion at a target dose of 1 x 10^8 anti-cluster of differentiation (CD)19 chimeric antigen receptor (CAR) transduced autologous T cells on Day1.
Intervention Type
Biological
Intervention Name(s)
Relmacabtagene Autoleucel
Other Intervention Name(s)
JWCAR029
Intervention Description
A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Intervention Description
Administered according to package insert
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
Administered according to package insert
Primary Outcome Measure Information:
Title
ORR at 3 month
Description
Percentage of participants with CR [CMR;CRR] or PR [partial metabolic response (PMR);
Time Frame
3 months
Secondary Outcome Measure Information:
Title
CRR at 3 month
Description
Complete response rate in subjects at 3 month
Time Frame
3 months
Title
Duration of response (DOR)
Description
Time from first response(PR or CR) to disease progression or death from any cause.
Time Frame
up to 2 years after Relmacabtagene Autoleucel infusion
Title
Duration of complete remission (DoCR)
Description
Time from complete response (CR) to disease progression or death from any cause.
Time Frame
up to 2 years after Relmacabtagene Autoleucel infusion
Title
Duration of partial remission (DoPR)
Description
Time from partial response (PR) to disease progression or death from any cause.
Time Frame
up to 2 years after Relmacabtagene Autoleucel infusion
Title
Time to response (TTR)
Description
Time from JWCAR029 infusion to first documentation of CR or PR
Time Frame
up to 2 years after Relmacabtagene Autoleucel infusion
Title
Progression-Free Survival (PFS)
Description
PFS is defined as the time from the Relmacabtagene Autoleucel infusion date to the date of disease progression per Lugano classification or death from any cause.
Time Frame
up to 2 years after Relmacabtagene Autoleucel infusion
Title
Overall Survival (OS)
Description
OS is defined as the time from Relmacabtagene Autoleucel infusion to the date of death from any cause.
Time Frame
up to 2 year after Relmacabtagene Autoleucel infusion
Title
Adverse events (AEs)
Description
Types, frequency, and severity of adverse events and laboratory anomalies Physiological parameter
Time Frame
up to 2 year after Relmacabtagene Autoleucel infusion
Title
Pharmacokinetic (PK)- Cmax of Relmacabtagene Autoleucel
Description
Maximum observed concentration of Relmacabtagene Autoleucel in peripheral blood
Time Frame
up to 1 year after Relmacabtagene Autoleucel infusion
Title
Pharmacokinetic (PK)- Tmax of Relmacabtagene Autoleucel
Description
Time to maximum concentration of Relmacabtagene Autoleucel in peripheral blood
Time Frame
up to 1 year after Relmacabtagene Autoleucel infusion
Title
Pharmacokinetic (PK)- AUC of Relmacabtagene Autoleucel
Description
Area under the concentration vs time curve of Relmacabtagene Autoleucel
Time Frame
up to 1 year after Relmacabtagene Autoleucel infusion
Title
The concentration of Car-T cell
Description
The concentration of Car-T cell in peripheral blood
Time Frame
up to 1 year after Relmacabtagene Autoleucel infusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age≥18 years; Signed written informed consent obtained prior to any study procedures; Histologically confirmed relapsed or refractory (R/R) aggressive B-cell NHL of the following histologiesLBCL as defined by the World Health Organization (WHO) Classification 2022:Diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), high-grade B-cell lymphoma (HGL) with MYC and BCL2 rearrangements,HGL-NOS, Primary mediastinal large B-cell lymphoma, Follicular lymphoma Grade 3B (FL3B),Indolent B-NHL-transformed large B-cell lymphoma with adequate prior treatment with anthracycline-containing agents and rituximab or other CD20-targeted agents; Subjects must meet the definition of refractory or relapsed; Subjects were not eligible for HDCT/ASCT based on the investigator's assessment ; Adequate organ function; Presence of positive PET assessable lesions as determined by the Lugano criteria ; Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; Expected survival greater than 12 weeks; Adequate vascular access for leukapheresis procedure; Women of childbearing potential must agree to use highly effective methods of contraception for at least 28 days prior to lymphocyte clearance chemotherapy through 2 year after Relmacabtagene Autoleucel infusion; Males who have partners of childbearing potential must agree to use an effective barrier contraceptive method for 2 year after Relmacabtagene Autoleucel infusion; Exclusion Criteria: Subjects with non-Hodgkin's lymphoma who have received second or more line therapy; Lymphoma of the primary center (subjects with secondary central nervous system lymphoma are allowed to enroll; History of another primary malignancy that has not been in remission for at least 2 years; Subjects has active 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; Uncontrolled diabetes and hypertension; Presence of acute or chronic graft-versus-host disease (GVHD); Active autoimmune disease requiring immunosuppressive therapy; History of any serious cardiovascular disease or presence of clinically relevant CNS pathology; Pregnant or nursing women; Subjects Received an autologous or allogeneic hematopoietic stem cell transplant; 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; Received live vaccination within 6 weeks prior to lymphocyte clearance chemotherapy; History of severe hypersensitivity reactions to any of the drug ingredients used in this study product.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Medical JWCAR029, PhD
Phone
+86 21 50464201
Email
JWCAR029Medical@jwtherapeutics.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weili Zhao, PhD
Organizational Affiliation
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Depei Wu, PhD
Organizational Affiliation
The First Affiliated Hospital of Soochow University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-sen University Cancer Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qingqing Cai
Email
caiqq@sysucc.org.cn
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keshu Zhou
Email
drzhouks77@163.com
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mingzhi Zhang
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui Zhou
Email
liyajun@hnca.org.cn
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Depei Wu, PhD
Email
drwudepei@163.com
Facility Name
Shandong Cancer Hospital
City
Jinan
State/Province
Shandong
Country
China
Facility Name
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weili Zhao, PhD
Email
zwl_trial@163.com
Facility Name
Institute of Hematology&Hospital of Blood Disease CAMS
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dehui Zou, PhD
Email
zoudehui@ihcams.ac.cn
Facility Name
Tianjin Cancer Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Facility Name
The First Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Jin
Email
jiej0503@163.com
Facility Name
Beijing Tongren Hospital
City
Beijing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liang Wang
Email
wangliangtrhos@126.com
Facility Name
Peking Union Medical College Hospital
City
Beijing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Zhang
Email
vv1223@vip.sina.com
Facility Name
Jiangsu Provincial People's Hospital
City
Nanjing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huayuan Zhu
Email
huayuan.zhu@hotmal.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Relmacabtagene Autoleucel as Second-Line Therapy in Adult Patients With Aggressive B-cell NHL

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