Relmacabtagene Autoleucel: A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells
Fludarabine: Administered according to package insert
Cyclophosphamide: Administered according to package insert
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Age≥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.
Primary outcome measure(s)
ORR at 3 month — 3 months Percentage of participants with CR \[CMR;CRR\] or PR \[partial metabolic response (PMR);
Trial sites (13)
Facility
City
Region
Status
Sun Yat-sen University Cancer Hospital
Guangzhou
Guangdong
Henan Cancer Hospital
Zhengzhou
Henan
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
Henan
Hunan Cancer Hospital
Changsha
Hunan
The First Affiliated Hospital of Soochow University
Suzhou
Jiangsu
Shandong Cancer Hospital
Jinan
Shandong
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,
Shanghai
Shanghai Municipality
Institute of Hematology&Hospital of Blood Disease CAMS
Tianjin
Tianjin Municipality
Tianjin Cancer Hospital
Tianjin
Tianjin Municipality
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou
Zhejiang
Beijing Tongren Hospital
Beijing
China
Peking Union Medical College Hospital
Beijing
China
Jiangsu Provincial People's Hospital
Nanjing
China
More Shanghai Ming Ju Biotechnology Co., Ltd. trials in China
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.