Relmacabtagene Autoleucel as Second-Line Therapy in Adult Patients With Aggressive B-cell NHL

• Status: Not yet recruiting
• Trial end date: 2027-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Ming Ju Biotechnology Co., Ltd.
• Treatments: Cyclophosphamide; Fludarabine

Criteria

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.