Active, not recruiting
Phase 2
Relmacabtagene Autoleucel As Second-Line Therapy in Adult Patients with Aggressive B-cell NHL
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 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
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 |
|
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