Status:
ACTIVE_NOT_RECRUITING
Relmacabtagene Autoleucel As Second-Line Therapy in Adult Patients with Aggressive B-cell NHL
Lead Sponsor:
Shanghai Ming Ju Biotechnology Co., Ltd.
Conditions:
Lymphoma, Large B-Cell, Diffuse
Follicular Lymphoma Grade 3B
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 h...
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 ar...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 3 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 4 2029
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT06093841
Start Date
November 3 2023
End Date
November 4 2029
Last Update
February 11 2025
Active Locations (13)
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1
Sun Yat-sen University Cancer Hospital
Guangzhou, Guangdong, China
2
Henan Cancer Hospital
Zhengzhou, Henan, China
3
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
4
Hunan Cancer Hospital
Changsha, Hunan, China