Relapsed or Refractory B-cell Acute Lymphoblastic LeukemiaPhase 1NCT06927466
A Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of B019 Injection in Subjects With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia.
A Phase 1 study testing B019 in people with Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia, run by Shanghai Pharmaceutical Group Biological Therapy Technology Co., Ltd. at 8 sites in China.
Trial summary
The purpose of the study is to evaluate the safety and tolerability of B019 in subjects. Read more about this study
- Who is it for?
- Ages 3 to 25 years
- Conditions the study is for
- Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia
- 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
- 33 participants
- Where
- 8 sitesChina
- Study dates
- 19 Sep 2024to 30 Jun 2028
- 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 3 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- The patient himself/herself , and/or his/her legal guardian, agree to participate in the trial and sign the informed consent form；
- Meet the diagnostic criteria for recurrent or refractory acute B cell lymphoblastic leukemia；
- Documentation of CD19/CD22 tumor expression
- 3. Liver, kidney, lung and heart function meet requirements; 4. Expected survival >3 months; 5. Women of childbearing age and all post-adolescent male participants are willing to use highly effective contraceptive methods within 1 year after the infusion of B019 injection. At the same time, the subject should promise not to donate eggs or sperm for assisted reproduction for 1 year after the cell infusion.
- -
Who cannot join
- Active CNS involvement by malignancy；
- Isolated extramedullary leukemia recurrence；
- Subjects with ≥grade 2 acute or moderate to severe chronic graft-versus-host disease (GVHD) within 4 weeks prior to screening;
- Has had treatment with any prior CAR-T therapy or other therapy abandoned in protocal.
- 4. Subjects who received therapy abandoned in protocal before PBMC (peripheral blood mononuclear cells) collection or before B019 injection; 5.Active other malignancy in 5 years. 6. Subjects who are positive for any of HBsAg, HBeAg, HBeAb, HBcAb, HCV-RNA, HIV EBV DNA, CMV DNA, HTLV-ab.
- 7. Other situations deemed inappropriate for participation in this study by the investigator.
- -
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
China8 sites, 8 recruiting
- Recruiting
Peking University People's Hospital
Beijing
Yifei Cheng
- Recruiting
Jiangxi Province pediatric hospital
Nanchang
Fei He
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang
Fei Li
- Recruiting
Children's Hospital of Shanghai
Shanghai
Jingbo Shao
- Recruiting
Shanghai Children's Medical Center
Shanghai
Jing Chen
- Recruiting
Children's Hospital of Soochow University
Suzhou
Shaoyan Hu
- Recruiting
Tongji Hospital
Wuhan
Jia Kui
- Recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou
Zhenyu Li
About this study
The purpose of the study is to evaluate the safety and tolerability of B019 in subjects.
- Being tested
- B019
- Medical subject headings
- Recurrence, Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B019Biological
B019： Intravenous infusion, 1.0×10^6 CAR T cell/kg-10.0×10^6 CAR T cell/kg
| Study group | Role | What they receive |
|---|---|---|
| B019 | Experimental | Not described Receives: Biological: B019 |
What is being measured
The primary outcome is the main question the study is designed to answer.
(一) Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Measured: Approximately 2 years
Secondary outcomes (4)
The overall response rate (ORR)
Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.
Measured: 3 months
Overall Survival (OS)
Determination of the overall survival times of all patients.
Measured: Approximately 2 years
PK(Pharmacokinetics):Tmax
Time to peak plasma concentration (Tmax)
Measured: Approximately 2 years
PK(Pharmacokinetics):Cmax
Maximum serum concentration(Cmax)
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 posted15 Apr 2025
- Study start19 Sep 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2028 (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 Acute Lymphoblastic LeukemiaStudies 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
- 33 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
- NCT06927466
- Sponsor's protocol ID
- B019-001
- Status last verified
- Aug 2026
- First submitted
- 7 Apr 2025
- Last updated
- 17 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 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of B019 Injection in Subjects With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia.
- ClinicalTrials.gov ID
- NCT06927466
- Acronym / sponsor ID
- B019-001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Shanghai Pharmaceutical Group Biological Therapy Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Sep 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 15 Apr 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 and tolerability of B019 in subjects.
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 | Biological: B019 |
Who may qualify
- Ages
- 3 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- The patient himself/herself , and/or his/her legal guardian, agree to participate in the trial and sign the informed consent form；
- Meet the diagnostic criteria for recurrent or refractory acute B cell lymphoblastic leukemia；
- Documentation of CD19/CD22 tumor expression
- 3. Liver, kidney, lung and heart function meet requirements; 4. Expected survival >3 months; 5. Women of childbearing age and all post-adolescent male participants are willing to use highly effective contraceptive methods within 1 year after the infusion of B019 injection. At the same time, the subject should promise not to donate eggs or sperm for assisted reproduction for 1 year after the cell infusion.
- -
Key exclusion criteria (7 listed)
- Active CNS involvement by malignancy；
- Isolated extramedullary leukemia recurrence；
- Subjects with ≥grade 2 acute or moderate to severe chronic graft-versus-host disease (GVHD) within 4 weeks prior to screening;
- Has had treatment with any prior CAR-T therapy or other therapy abandoned in protocal.
- 4. Subjects who received therapy abandoned in protocal before PBMC (peripheral blood mononuclear cells) collection or before B019 injection; 5.Active other malignancy in 5 years. 6. Subjects who are positive for any of HBsAg, HBeAg, HBeAb, HBcAb, HCV-RNA, HIV EBV DNA, CMV DNA, HTLV-ab.
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, 1.0×10^6 CAR T cell/kg-10.0×10^6 CAR T cell/kg | Biological | B019 |
Primary outcome
(一) Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Approximately 2 years
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
4 secondary outcomes
The overall response rate (ORR)
Time frame: 3 months
Overall Survival (OS)
Time frame: Approximately 2 years
PK(Pharmacokinetics):Tmax
Time frame: Approximately 2 years
PK(Pharmacokinetics):Cmax
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 17 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.
8 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 Acute Lymphoblastic Leukemia, run by Shanghai Pharmaceutical Group Biological Therapy Technology Co., Ltd. at 8 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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 17 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 8 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 Jing Chen (0086-021-38626161, chenjing@scmc.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(一) Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (time frame: Approximately 2 years). 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 17 Aug 2026.