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

NCT ID: NCT06970496

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2027-12-31

Brief 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.

Conditions

Relapsed or Refractory B Cell Non Hodgkin Lymphoma

Study Design

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

Study Groups

B019

Group Type: EXPERIMENTAL

B019

Intervention Type: DRUG

B019： Intravenous infusion, 2.0×10\^6 cell/kg-8.0×10\^6 cell/kg

Interventions

B019

B019： Intravenous infusion, 2.0×10\^6 cell/kg-8.0×10\^6 cell/kg

Intervention Type: DRUG

Eligibility Criteria

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;

11. A history of severe allergic reactions to the drugs or excipients that were definitely needed in this study. Or have a history of allergic reactions to tocilizumab;

12. Any indwelling tubes or drainage tubes in the bodies, the use of dedicated central venous access catheters is permitted;

13. Pregnant or breastfeeding women; or male or female subjects who are unwilling to use contraception from the time of signing the ICF until 1 year after receiving B019 injection cell infusion or until CAR is detectable in peripheral blood.;

14. The subjects who have participated in other clinical studies within the past 1 month, or whose last medication use for the last clinical study is still within the 5 half-life periods of the current drug at the time of screening;

15. Other circumstances that the researchers consider unsuitable for participating in this study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Pharmaceutical Group Biological Therapy Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

China

Central Contacts

Xianmin Song

Role: CONTACT

shiyilunli@sina.com

0086-021-36126254

Facility Contacts

Zhiming Li

Role: primary

Yuhua Li

Role: primary

Wuping Li

Role: primary

Weili Zhao

Role: primary

Xianmin Song

Role: primary

Songfu Jiang

Role: primary

Guangxu Gao

Role: primary

Other Identifiers

B019-102

Identifier Type: -

Identifier Source: org_study_id