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

NCT06970496 | Not Yet Recruiting Phase 1

• 1 other identifier: B019-102
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 7

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

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicity (DLT)

  Measurement of DLT of B019 in all subjects

  Approximately 2 years

• MTD（Maximum tolerated dose）

  Maximum tolerated dose

  Approximately 2 years

Secondary Outcomes (1)

• The overall response rate (ORR)

  Approximately 2 years

Study Arms (1)

B019

EXPERIMENTAL

Drug: B019

Interventions

B019 DRUG

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

B019

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who can fully understand this trial and voluntarily sign the informed consent form (ICF) before any research-related procedures;
• Histologically confirmed B-cell non-Hodgkin's lymphoma (B-NHL) with specified pathological subtypes;
• Histologically confirmed CD19 and/or CD22 positivity;
• Expected survival time exceeding 12 weeks;
• ECOG performance status 0-1 (Ia) or 0-2 (Ib);
• At least one measurable lesion in two dimensions according to the Lugano 2014 criteria;
• 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.

You may not qualify if:

• Primary central nervous system (CNS) lymphoma; However, secondary CNS lymphoma without clinical symptoms can be enrolled after being determined by the researchers；
• Use of the prescribed drugs or treatments within the specified time before the collection of PBMC;
• Prior allogeneic hematopoietic stem cell transplantation;
• Systemic intravenous infusion treatment or uncontrollable bacterial, fungal or viral infection within 2 weeks before signing the ICF;
• A history of deep vein thrombosis or pulmonary embolism or anticoagulant therapy within 6 months before signing the ICF;
• A clinically significant history of severe heart disease within 6 months before signing the ICF;
• Terminal organ damage or autoimmune diseases requiring systemic immunosuppressive/systemic treatments within 2 years before signing the ICF; Or have graft-versus-host disease;
• Prescribed malignant tumors within 5 years before signing the ICF;
• Intestinal obstruction caused by tumor compression or vascular compression requiring emergency treatment; gastrointestinal involvement with a risk of bleeding assessed by the researchers;
• Clinically significant CNS diseases in the past or at the time of screening;
• 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;
• Any indwelling tubes or drainage tubes in the bodies, the use of dedicated central venous access catheters is permitted;
• 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.;
• 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;
• Other circumstances that the researchers consider unsuitable for participating in this study.

Sponsors & Collaborators

• Shanghai Pharmaceutical Group Biological Therapy Technology Co., Ltd.: lead

Study Sites (7)

Sun Yat-sen University Cancer Center

Guangzhou, China

Location

Zhujiang Hospital of Southern Medical University

Guangzhou, China

Location

Jiangxi Cancer Hospital

Nanchang, China

Location

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, China

Location

Shanghai General Hospital

Shanghai, China

Location

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, China

Location

Xijing Hospital

Xi'an, China

Location

MeSH Terms

Conditions

Recurrence; Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Xianmin Song

CONTACT

0086-021-36126254; shiyilunli@sina.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 14, 2025
• Study Start (Estimated): August 31, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 5, 2026

Record last verified: 2025-05

Locations

CN (7)