Relapsed or Refractory B Cell Non Hodgkin LymphomaPhase 1NCT06970496
A Clinical Trial of B019 Injection in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma.
A Phase 1 study testing B019 in people with Relapsed or Refractory B Cell Non Hodgkin Lymphoma, run by Shanghai Pharmaceutical Group Biological Therapy Technology Co., Ltd. at 7 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Relapsed or Refractory B Cell Non Hodgkin Lymphoma
- What is being tested?
- B019
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 7 sitesChina
- Study dates
- 31 Aug 2026to 31 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 15Show fewer
- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
China7 sites
Sun Yat-sen University Cancer Center
Guangzhou
Zhiming Li
Zhujiang Hospital of Southern Medical University
Guangzhou
Yuhua Li
Jiangxi Cancer Hospital
Nanchang
Wuping Li
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai
Weili Zhao
Shanghai General Hospital
Shanghai
Xianmin Song
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou
Songfu Jiang
Xijing Hospital
Xi'an
Guangxu Gao
About this study
Official title: 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.
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.
- Being tested
- B019
- Medical subject headings
- Recurrence, Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B019Drug
B019： Intravenous infusion, 2.0×10^6 cell/kg-8.0×10^6 cell/kg
| Study group | Role | What they receive |
|---|---|---|
| B019 | Experimental | Not described Receives: Drug: B019 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT)
Measurement of DLT of B019 in all subjects
Measured: Approximately 2 years
MTD（Maximum tolerated dose）
Maximum tolerated dose
Measured: Approximately 2 years
Secondary outcomes (1)
The overall response rate (ORR)
Tumor response will be evaluated according to the Lugano 2014 criteria.
Measured: Approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start31 Aug 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory B Cell Non Hodgkin LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pharmaceutical Group Biological Therapy Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06970496
- Sponsor's protocol ID
- B019-102
- Status last verified
- Aug 2026
- First submitted
- 6 May 2025
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06970496
- Acronym / sponsor ID
- B019-102
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Shanghai Pharmaceutical Group Biological Therapy Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| B019 | Experimental | Drug: B019 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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);
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| B019B019： Intravenous infusion, 2.0×10^6 cell/kg-8.0×10^6 cell/kg | Drug | B019 |
Primary outcome
Dose-limiting toxicity (DLT)
Time frame: Approximately 2 years
Measurement of DLT of B019 in all subjects
MTD（Maximum tolerated dose）
Time frame: Approximately 2 years
Maximum tolerated dose
1 secondary outcome
The overall response rate (ORR)
Time frame: Approximately 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing B019 in people with Relapsed or Refractory B Cell Non Hodgkin Lymphoma, run by Shanghai Pharmaceutical Group Biological Therapy Technology Co., Ltd. at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xianmin Song (0086-021-36126254, shiyilunli@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (DLT) (time frame: Approximately 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.