Trial Title:
Relmacabtagene Autoleucel as Second-Line Therapy in Adult Patients With Aggressive B-cell NHL
NCT ID:
NCT06093841
Condition:
Lymphoma, Large B-Cell, Diffuse
Follicular Lymphoma Grade 3B
High-grade B-cell Lymphoma
Mediastinal B-Cell Diffuse Large Cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, Large B-Cell, Diffuse
Aggression
Cyclophosphamide
Fludarabine
Conditions: Keywords:
Relmacabtagene Autoleucel
aggressive B-cell non-Hodgkin lymphoma
Chimeric antigen receptor T cells
second-line
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Relmacabtagene Autoleucel
Description:
A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells
Arm group label:
Relmacabtagene Autoleucel
Other name:
JWCAR029
Intervention type:
Drug
Intervention name:
Fludarabine
Description:
Administered according to package insert
Arm group label:
Relmacabtagene Autoleucel
Intervention type:
Drug
Intervention name:
Cyclophosphamide
Description:
Administered according to package insert
Arm group label:
Relmacabtagene Autoleucel
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Ageā„18 years;
2. Signed written informed consent obtained prior to any study procedures;
3. 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;
4. Subjects must meet the definition of refractory or relapsed;
5. Subjects were not eligible for HDCT/ASCT based on the investigator's assessment ;
6. Adequate organ function;
7. Presence of positive PET assessable lesions as determined by the Lugano criteria ;
8. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
9. Expected survival greater than 12 weeks;
10. Adequate vascular access for leukapheresis procedure;
11. 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:
1. Subjects with non-Hodgkin's lymphoma who have received second or more line therapy;
2. Lymphoma of the primary center (subjects with secondary central nervous system
lymphoma are allowed to enroll;
3. History of another primary malignancy that has not been in remission for at least 2
years;
4. Subjects has active HBV, HCV, HIV or syphilis infection at the time of screening;
5. Deep venous thrombosis (DVT)/Pulmonary embolism (PE), or DVT/PE requires
anti-coagulation within 3 months prior to signing the ICF;
6. Subjects with uncontrolled systemic fungal, bacterial, viral or other infection;
7. Uncontrolled diabetes and hypertension;
8. Presence of acute or chronic graft-versus-host disease (GVHD);
9. Active autoimmune disease requiring immunosuppressive therapy;
10. History of any serious cardiovascular disease or presence of clinically relevant CNS
pathology;
11. Pregnant or nursing women;
12. Subjects Received an autologous or allogeneic hematopoietic stem cell transplant;
13. Uncontrolled conditions or unwillingness or inability to follow the procedures
required in the protocol;
14. Received CAR T-cell or other genetically-modified T-cell therapy previously;
15. Received live vaccination within 6 weeks prior to lymphocyte clearance chemotherapy;
16. History of severe hypersensitivity reactions to any of the drug ingredients used in
this study product.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen University Cancer Hospital
Address:
City:
Guangzhou
Country:
China
Contact:
Last name:
Qingqing Cai
Email:
caiqq@sysucc.org.cn
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Country:
China
Contact:
Last name:
Keshu Zhou
Email:
drzhouks77@163.com
Facility:
Name:
The First Affiliated Hospital of Zhengzhou University
Address:
City:
Zhengzhou
Country:
China
Contact:
Last name:
Mingzhi Zhang
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Country:
China
Contact:
Last name:
Hui Zhou
Email:
liyajun@hnca.org.cn
Facility:
Name:
The First Affiliated Hospital of Soochow University
Address:
City:
Suzhou
Zip:
215006
Country:
China
Contact:
Last name:
Depei Wu, PhD
Email:
drwudepei@163.com
Facility:
Name:
Shandong Cancer Hospital
Address:
City:
Jinan
Country:
China
Facility:
Name:
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,
Address:
City:
Shanghai
Zip:
200025
Country:
China
Contact:
Last name:
Weili Zhao, PhD
Email:
zwl_trial@163.com
Facility:
Name:
Institute of Hematology&Hospital of Blood Disease CAMS
Address:
City:
Tianjin
Zip:
300000
Country:
China
Contact:
Last name:
Dehui Zou, PhD
Email:
zoudehui@ihcams.ac.cn
Facility:
Name:
Tianjin Cancer Hospital
Address:
City:
Tianjin
Country:
China
Facility:
Name:
The First Affiliated Hospital of Zhejiang University School of Medicine
Address:
City:
Hangzhou
Country:
China
Contact:
Last name:
Jie Jin
Email:
jiej0503@163.com
Facility:
Name:
Beijing Tongren Hospital
Address:
City:
Beijing
Country:
China
Contact:
Last name:
Liang Wang
Email:
wangliangtrhos@126.com
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Country:
China
Contact:
Last name:
Wei Zhang
Email:
vv1223@vip.sina.com
Facility:
Name:
Jiangsu Provincial People's Hospital
Address:
City:
Nanjing
Country:
China
Contact:
Last name:
Huayuan Zhu
Email:
huayuan.zhu@hotmal.com
Start date:
November 2023
Completion date:
February 2027
Lead sponsor:
Agency:
Shanghai Ming Ju Biotechnology Co., Ltd.
Agency class:
Industry
Source:
Shanghai Ming Ju Biotechnology Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06093841
