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Clinical Trials in China / NCT06093841
Active, not recruiting Phase 2

Relmacabtagene Autoleucel As Second-Line Therapy in Adult Patients with Aggressive B-cell NHL

NCT06093841 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Ming Ju Biotechnology Co., Ltd.
Phase
Phase 2
Started
2023-11-03
Last updated
2025-02-11

Condition(s) studied

Lymphoma, Large B-Cell, DiffuseFollicular Lymphoma Grade 3BHigh-grade B-cell LymphomaMediastinal B-Cell Diffuse Large Cell Lymphoma

Investigational drug(s) / intervention(s)

Relmacabtagene AutoleucelFludarabineCyclophosphamide

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)

Trial sites (13)

FacilityCityRegionStatus
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

Other trials for the same condition

Official registry record

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.

View NCT06093841 on ClinicalTrials.gov ↗ ← All trials in China