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

NCT ID: NCT06093841

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-03
• Study Completion Date: 2029-11-04

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 haematopoietic stem cell transplantation.

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 are refractory to, a single line of immunochemotherapy for aggressive Bcell NHL and are ineligible for HSCT (as defined in the eligibility criteria). Subjects will be treated with lymphodepleting chemotherapy and JWCAR029.

Conditions

Lymphoma, Large B-Cell, Diffuse; Follicular Lymphoma Grade 3B; High-grade B-cell Lymphoma; Mediastinal B-Cell Diffuse Large Cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Relmacabtagene Autoleucel

Experimental: Relmacabtagene Autoleucel Participants will receive cyclophosphamide250 mg/m\^2/day intravenously (IV) and fludarabine 25 mg/m\^2/day IV conditioning chemotherapy for 3 days followed by Relmacabtagene Autoleucel administered as a single IV infusion at a target dose of 1 x 10\^8 anti-cluster of differentiation (CD)19 chimeric antigen receptor (CAR) transduced autologous T cells on Day1.

Group Type: EXPERIMENTAL

Relmacabtagene Autoleucel

Intervention Type: BIOLOGICAL

A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells

Fludarabine

Intervention Type: DRUG

Administered according to package insert

Cyclophosphamide

Intervention Type: DRUG

Administered according to package insert

Interventions

Relmacabtagene Autoleucel

A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells

Intervention Type: BIOLOGICAL

Fludarabine

Administered according to package insert

Intervention Type: DRUG

Cyclophosphamide

Administered according to package insert

Intervention Type: DRUG

Other Intervention Names

JWCAR029

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Ming Ju Biotechnology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Weili Zhao, PhD

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Depei Wu, PhD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Soochow University

Locations

Sun Yat-sen University Cancer Hospital

Guangzhou, Guangdong, China

Henan Cancer Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Hunan Cancer Hospital

Changsha, Hunan, China

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Shandong Cancer Hospital

Jinan, Shandong, China

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,

Shanghai, Shanghai Municipality, China

Institute of Hematology&Hospital of Blood Disease CAMS

Tianjin, Tianjin Municipality, China

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Beijing Tongren Hospital

Beijing, , China

Peking Union Medical College Hospital

Beijing, , China

Jiangsu Provincial People's Hospital

Nanjing, , China

Countries

China

Other Identifiers

JWCAR029216

Identifier Type: -

Identifier Source: org_study_id