Status:
NOT_YET_RECRUITING
A Clinical Trial of B019 Injection in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma.
Lead Sponsor:
Shanghai Pharmaceutical Group Biological Therapy Technology Co., Ltd.
Conditions:
Relapsed or Refractory B Cell Non Hodgkin Lymphoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 31 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06970496
Start Date
December 31 2025
End Date
December 31 2027
Last Update
November 20 2025
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Sun Yat-sen University Cancer Center
Guangzhou, China
2
Zhujiang Hospital of Southern Medical University
Guangzhou, China
3
Jiangxi Cancer Hospital
Nanchang, China
4
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China