Clinical trial · Interventional
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.
NCT06970496CI-TRIAL-00122088not yet recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed or Refractory B Cell Non Hodgkin Lymphoma | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| B019 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- B019
- interventionNames
- Drug: B019
Primary outcomes (2)
- measure
- Dose-limiting toxicity (DLT)
- timeFrame
- Approximately 2 years
- description
- Measurement of DLT of B019 in all subjects
- measure
- MTD(Maximum tolerated dose)
- timeFrame
- Approximately 2 years
- description
- Maximum tolerated dose
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.