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

NCT06093841 | Active Not Recruiting Phase 2

• 1 other identifier: JWCAR029216
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 13

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.

Conditions

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

Keywords

Relmacabtagene Autoleucel; aggressive B-cell non-Hodgkin lymphoma; Chimeric antigen receptor T cells; second-line

Outcome Measures

Primary Outcomes (1)

• ORR at 3 month

  Percentage of participants with CR \[CMR;CRR\] or PR \[partial metabolic response (PMR);

  3 months

Secondary Outcomes (12)

• CRR at 3 month

  3 months

• Duration of response (DOR)

  up to 2 years after Relmacabtagene Autoleucel infusion

• Duration of complete remission (DoCR)

  up to 2 years after Relmacabtagene Autoleucel infusion

• Duration of partial remission (DoPR)

  up to 2 years after Relmacabtagene Autoleucel infusion

• Time to response (TTR)

  up to 2 years after Relmacabtagene Autoleucel infusion

Study Arms (1)

Relmacabtagene Autoleucel

EXPERIMENTAL

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.

Biological: Relmacabtagene Autoleucel; Drug: Fludarabine; Drug: Cyclophosphamide

Interventions

Relmacabtagene Autoleucel BIOLOGICAL

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

Also known as: JWCAR029

Relmacabtagene Autoleucel

Fludarabine DRUG

Administered according to package insert

Relmacabtagene Autoleucel

Cyclophosphamide DRUG

Administered according to package insert

Relmacabtagene Autoleucel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai Ming Ju Biotechnology Co., Ltd.: lead

Study Sites (13)

Sun Yat-sen University Cancer Hospital

Guangzhou, Guangdong, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

Hunan Cancer Hospital

Changsha, Hunan, China

Location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

Shandong Cancer Hospital

Jinan, Shandong, China

Location

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

Shanghai, Shanghai Municipality, 200025, China

Location

Institute of Hematology&Hospital of Blood Disease CAMS

Tianjin, Tianjin Municipality, 300000, China

Location

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, China

Location

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

Beijing Tongren Hospital

Beijing, China

Location

Peking Union Medical College Hospital

Beijing, China

Location

Jiangsu Provincial People's Hospital

Nanjing, China

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

relmacabtagene autoleucel; fludarabine; Cyclophosphamide

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Weili Zhao, PhD

  Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

• Depei Wu, PhD

  The First Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: October 23, 2023
• Study Start: November 3, 2023
• Primary Completion: January 21, 2024
• Study Completion (Estimated): November 4, 2029
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (13)