A Clinical Trial of B019 Injection in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma.

A Phase I Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Efficacy of B019 Injection in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma.

NCT06970496•Shanghai Pharmaceutical Group Biological Therapy Technology Co., Ltd.

View on ClinicalTrials.gov

Summary

The purpose of the study is to evaluate the safety、tolerability and preliminary efficacy of B019 in subjects with relapsed or refractory B-cell non-Hodgkin's lymphoma.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subjects who can fully understand this trial and voluntarily sign the informed consent form (ICF) before any research-related procedures;
•2. Histologically confirmed B-cell non-Hodgkin's lymphoma (B-NHL) with specified pathological subtypes;
•3. Histologically confirmed CD19 and/or CD22 positivity;
•4. Expected survival time exceeding 12 weeks;
•5. ECOG performance status 0-1 (Ia) or 0-2 (Ib);
•6. At least one measurable lesion in two dimensions according to the Lugano 2014 criteria;
•7. Bone marrow, liver, kidney, and cardiac-pulmonary functions meeting the specified requirements; 8 Subjects who were evaluated by the researchers as tolerant to the collection of peripheral blood mononuclear cells (PBMC); 9 Subjects who were evaluated by the researchers as having no contraindications for lymphodepleting chemotherapy.

Exclusion Criteria

•1. Primary central nervous system (CNS) lymphoma; However, secondary CNS lymphoma without clinical symptoms can be enrolled after being determined by the researchers；
•2. Use of the prescribed drugs or treatments within the specified time before the collection of PBMC;
•3. Prior allogeneic hematopoietic stem cell transplantation;
•4. Systemic intravenous infusion treatment or uncontrollable bacterial, fungal or viral infection within 2 weeks before signing the ICF;
•5. A history of deep vein thrombosis or pulmonary embolism or anticoagulant therapy within 6 months before signing the ICF;
•6. A clinically significant history of severe heart disease within 6 months before signing the ICF;
•7. Terminal organ damage or autoimmune diseases requiring systemic immunosuppressive/systemic treatments within 2 years before signing the ICF; Or have graft-versus-host disease;
•8. Prescribed malignant tumors within 5 years before signing the ICF;
•9. Intestinal obstruction caused by tumor compression or vascular compression requiring emergency treatment; gastrointestinal involvement with a risk of bleeding assessed by the researchers;
•10. Clinically significant CNS diseases in the past or at the time of screening;
+5 more criteria

Locations (7)

Sun Yat-sen University Cancer Center

Guangzhou, China

Zhujiang Hospital of Southern Medical University

Guangzhou, China

Jiangxi Cancer Hospital

Nanchang, China

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, China

Shanghai General Hospital

Shanghai, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, China

Xijing Hospital

Xi'an, China

Key Dates

Start Date

December 31, 2025

Primary Completion Date

December 31, 2026

Completion Date

December 31, 2027

Last Updated

November 20, 2025

Enrollment

ESTIMATED participants

Conditions

Relapsed or Refractory B Cell Non Hodgkin Lymphoma

Interventions

B019

DRUG

Contacts

Xianmin Song

CONTACT

0086-021-36126254 shiyilunli@sina.com