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Acute Lymphoblastic LeukemiaPhase 2NCT05334823

A Study of pCAR-19B in the Treatment of CD19-positive Relapsed/Refractory B-ALL in Children and Adolescents

A Phase 2 study testing pCAR-19B cells in people with Acute Lymphoblastic Leukemia and Relapsed Pediatric ALL, run by Chongqing Precision Biotech Co., Ltd at 16 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a phase II clinical study to evaluate the safety and efficacy of pCAR-19 B cell autologous infusion preparation in the treatment of CD19-positive relapsed/refractory B-cell acute lymphoblastic leukemia. Read more about this study

Who is it for?
Ages 3 to 21 years
What is being tested?
pCAR-19B cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
16 sitesChina
Study dates
26 Jan 2022to 1 Jul 2029
Phase
Phase 2
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 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • The patient himself or his guardian agrees to participate in this clinical trial and signs the Informed Consent Form (ICF), indicating that he understands the purpose and procedures of this clinical trial and is willing to participate in the research;
  • Diagnosed with B-ALL，and meet one of the following conditions:
  • Refractory B-ALL: early-stage refractory patients who failed to achieve complete remission after 2 courses of standard induction chemotherapy;
  • Relapsed B-ALL: patients with early relapse (<12 months) after complete remission;or late relapse (≥12 months) after complete remission, and relapsed patients who have not achieved complete remission after standard treatment or have poor response to early treatment; experience Patients with 2 or more bone marrow recurrences; patients with recurrence after allogeneic hematopoietic stem cell transplantation;
  • For Ph+ALL patients, patients who have not achieved complete remission after receiving at least two Tyrosine kinase inhibitors (TKI) treatments or have relapsed after complete remission (except those who cannot tolerate TKI treatment or have contraindications to TKI treatment or have T315i mutation resistance to TKI drugs);
  • The malignant cells in the bone marrow were confirmed to express CD19 by flow cytometry;
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  • Bone marrow morphology at the time of screening indicated that blasts≥ 5%;
  • Eastern Cooperative Oncology Group (ECOG) 0-1 points ;
  • Expected survival is ≥ 12 weeks;
  • The function of important organs is basically normal:
  • Cardiac function: echocardiography showed cardiac ejection fraction ≥50%, and no obvious abnormality was found on electrocardiogram;
  • Renal function: serum creatinine≤2.0×ULN;
  • Liver function: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤5.0×ULN;
  • Total bilirubin≤2.0×ULN (for Gilbert syndrome, total bilirubin≤3.0×ULN);
  • Blood oxygen saturation≥92% in non-oxygen state.
  • No serious mental disorder;
  • Have apheresis or venous blood collection standards, and have no other contraindications for cell collection;
  • Subjects of childbearing age agree to use reliable and effective contraceptive methods for contraception (excluding rhythm contraception) from signing the informed consent to receiving pCAR-19B cell infusion within 1 year.

Who cannot join

  • Relapse of isolated extramedullary disease;
  • Active central nervous system leukemia at screening, defined as Central Nervous System (CNS)-grade 2 and 3 according to National Comprehensive Cancer Network (NCCN) guidelines (note: those with central nervous system involvement but improved after treatment can be included);
  • Those who have received CAR-T therapy or other gene-modified cell therapy before screening;
  • Received anti-CD19 drug treatment before screening;
  • Received the following anti-tumor treatments before screening: Received chemotherapy, targeted therapy and other drug treatments within 14 days or at least 5 half-lives (whichever is shorter); Received radiotherapy within 14 days;
  • HBsAg or HBcAb positive and hepatitis B virus (HBV) DNA is greater than the normal range; hepatitis C virus (HCV) antibody is positive and HCV RNA greater than the normal range; HIV antibody positive; syphilis positive; Cytomegalovirus (CMV) DNA positive;
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  • Have any of the following heart conditions:
  • New York Heart Association (NYHA) stage III or IV congestive heart failure;
  • Myocardial infarction or coronary artery bypass grafting within 6 months prior to enrollment (CABG);
  • Clinically significant ventricular arrhythmia, or history of syncope of unknown origin (by vasovagal except those caused by menstruation or dehydration);
  • History of severe non-ischemic cardiomyopathy;
  • Active infection or uncontrollable infection requiring systemic treatment within 1 week before screening;
  • The presence of grade 2-4 acute graft-versus-host disease (GVHD) or moderate to severe chronic GVHD within 4 weeks before screening;
  • Cerebrovascular accident or epileptic seizure within 6 months before screening;
  • Active autoimmune diseases；
  • Patients with malignant tumors other than acute lymphoblastic leukemia within 5 years before screening, except for fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical resection, and duct in situ after radical resection cancer;
  • Received live attenuated vaccine within 4 weeks before screening;
  • Participated in other interventional clinical studies before screening, including: the last use of unmarketed new drugs is less than 3 months from the time of cell reinfusion, or the last use of marketed drugs is less than 5 half-lives from the time of cell reinfusion;
  • Women who are pregnant or breastfeeding, and male or female subjects who plan to have children within 1 year after receiving pCAR-19B cell reinfusion;
  • Other investigators deem it inappropriate to participate in the study.

Trial locations and contacts

16 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Tianyou Wang, M.D contact

010-59616161

wangtianyou@bch.com.cn

Yicheng Zhang, M.D contact

18607140317

yczhang@tjh.tjmu.edu.cn

16 sites in 1 country

China16 sites, 16 recruiting

  • Beijing Children's Hospital.Capital Medical University

    Beijing, Beijing Municipality, 100000

    Tianyou Wang, M.D

    Tianyou Wang, M.D

    Recruiting

  • Beijing GoBroad Boren Hospital

    Beijing, Beijing Municipality, 100000

    Jing Pan, M.D

    Jin Pan, M.D

    Recruiting

  • The Second Xiangya Hospital, Central South University

    Changsha, Hunan, 410000

    Hongling Peng, M.D

    Hongling Peng, M.D

    Recruiting

  • West China Second University Hospital,Sichuan University

    Chengdu, Sichuan, 610000

    Ju Gao, M.D

    Ju Gao, M.D

    Recruiting

  • Children's Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400014

    Jianwen Xiao, M.D

    Jianwen Xiao, M.D

    Recruiting

  • Children's Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310052

    Yongmin Tang, M.D

    Yongmin Tang, M.D

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Henan, Zhengzhou, 450000

    Yufeng Liu, M.D

    Yufeng Liu, M.D

    Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330000

    Fei Li, M.D

    Fei Li, M.D

    Recruiting

  • Affiliated Drum Tower Hospital, Medical School of Nanjing University

    Nanjing, Jiangsu, 210008

    Bing Chen, M.D

    Bing Chen, M.D

    Recruiting

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

    Sixuan Qian, M.D

    Sixuan Qian, M.D

    Recruiting

  • Shenzhen Children's Hospital

    Shenzhen, Guangdong, 518026

    Sixi Liu, M.D

    Sixi Liu, M.D

    Recruiting

  • Children's Hospital Of Soochow University

    Suzhou, Jiangsu, 215000

    Shaoyan Hu, M.D

    Shaoyan Hu, M.D

    Recruiting

  • Institute Of Hematology&Blood Diseases Hospital,Chinese Academy Of Medicai Sciences

    Tianjin, Tianjin Municipality, 300000

    Xiaofan Zhu, M.D

    Xiaofan Zhu, M.D

    Recruiting

  • Pediatric Hematology department of Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, Hubei, 430000

    Qun Hu, M.D

    Qun Hu, M.D

    Recruiting

  • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, Hubei, 430000

    Yicheng Zhang, M.D

    Yicheng Zhang, M.D

    Recruiting

  • Xiehe Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, Hubei, 430000

    Runming Jin, M.D

    Runming Jin, M.D

    Recruiting

Other trials in China

About this study

Official title: A Phase II Clinical Study of Anti-CD19 CAR-T Therapy (pCAR-19B) in the Treatment of CD19-positive Relapsed/Refractory B-ALL

This is a phase II clinical study to evaluate the safety and efficacy of pCAR-19 B cell autologous infusion preparation in the treatment of CD19-positive relapsed/refractory B-cell acute lymphoblastic leukemia.

Read the detailed description

This is a multiple-center, single-arm, open-label study. After meeting the eligibility criteria and enrolling on the trial, patients will undergo leukapheresis for collection of autologous lymphocytes. Once cells have been manufactured, patients will then proceed to lymphodepleting chemotherapy with cyclophosphamide 20mg/kg and fludarabine 25mg/m^2 for 3 consecutive days followed by the infusion of CD19 CAR T-cells at a target dose of 0.6-2 x10^6 cells/kg.

Being tested
pCAR-19B cells
Keywords
CAR-T, CD19, B-ALL
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pCAR-19B cellsBiological

    Drug: pCAR-19B cells； Administration method: intravenous infusion； Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion.

Study groups in NCT05334823
Study groupRoleWhat they receive
pCAR-19B cellsExperimentalInfusion of pCAR-19B cells by dose of 0.6-2 x10^6 cells/kg
Receives: Biological: pCAR-19B cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate after pCAR-19B infusion [Effectiveness]

    Objective response rate includes CR, CRi.

    Measured: 3 months

Secondary outcomes (16)

  1. Minimal residual disease（MRD）

    MRD-negative ORR within 3 months by flow cytometry as assessed by Independent Review Committee (IRC) and investigator.

    Measured: 3 months

  2. Best overall response after pCAR-19B infusion [Effectiveness]

    Best overall response means the proportion of patients with the best efficacy (CR or CRi) after pCAR-19B cell therapy.

    Measured: 2 years

  3. Overall survival after pCAR-19B infusion [Effectiveness]

    Overall survival means the time from infusion of pCAR-19B cells to death of subjects from any cause

    Measured: 2 years

  4. Duration of response after pCAR-19B infusion [Effectiveness]

    Duration of response means the time from first assessment of CR or CRi to first assessment of disease recurrence or death from any cause, whichever occurs first

    Measured: 2 years

  5. Relapse free survival after pCAR-19B infusion [Effectiveness]

    Relapse free survival means time from subject infusion of pCAR-19B cells to first disease relapse or death from any cause (whichever occurs first)

    Measured: 2 years

  6. Event free survival after pCAR-19B infusion [Effectiveness]

    Event free survival means the time from the infusion of pCAR-19B cells to the time of the following events (whichever occurs first):

    1. Death from any cause after remission;
    2. Disease recurrence;
    3. Withdrawal from the clinical trial after treatment failure or meeting the withdrawal criteria.

    Measured: 2 years

  7. The incidence of Treatment Emergent Adverse Events (TEAE) of pCAR-19B infusion

    Number of participants with adverse events as assessed by CTCAE v5.0

    Measured: 2 years

  8. the incidence of adverse events related to treatment of pCAR-19B infusion

    Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Measured: 2 years

  9. the incidence of adverse event of special interest (AESI) of pCAR-19B infusion

    Number of participants with special interest adverse events as assessed by CTCAE v5.0,The following adverse events were defined as adverse events of special interest for this study:

    1. Cytokine release syndrome (CRS) of grade 3 and above;
    2. Immune effector cell-associated neurotoxicity syndrome (ICANS) of grade 3 and above;
    3. Grade 3 and above infection;
    4. Grade 3 and above acute tumor lysis syndrome;
    5. Unresolved cytopenias lasting 28 days.

    Measured: 2 years

  10. the incidence of RCL of pCAR-19B infusion

    RCL Detection: the incidence of Replication Competent Lentivirus.

    Measured: 2 years

  11. Pharmacokinetic data parameters of Cmax

    Analysis using CAR DNA copy number measured by qPCR: the highest concentration of pCAR-19B cells expanded in peripheral blood after administration

    Measured: 3 months

  12. Pharmacokinetic data parameters of Tmax

    Analysis using CAR DNA copy number measured by qPCR: the time to reach the highest concentration;

    Measured: 3 months

  13. Pharmacokinetic data parameters of AUC0-90d

    Analysis using CAR DNA copy number measured by qPCR: Area under the curve at 28 days and 90 days.

    Measured: 3 months

  14. Pharmacodynamics data parameters of the degree of clearance

    The degree of clearance of CD19-positive B cells at different blood collection time points after cell infusion

    Measured: 3 months

  15. Pharmacodynamics data parameters of CAR-T-related serum cytokines

    the concentration levels of IL-6 at each time point.

    Measured: 3 months

  16. Immunogenicity of pCAR-19B cells

    Analysis using anti-CAR antibodies measured by Meso Scale Discovery（Electrochemiluminescence）

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2022
  2. Study start26 Jan 2022
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion1 Jul 2029 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05334823
Sponsor's protocol ID
PB07
Status last verified
Sep 2026
First submitted
16 Mar 2022
Last updated
15 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Cao L, Zhou M, Wei Z, Zhu R, Chen H, Zhou L, Hu S, Bai Z, Wu S. Frontline therapy combining with intrathecal dexamethasone effectively alleviate immune effector cell-associated neurotoxicity syndrome in pediatric relapsed B-ALL receiving pCAR-19B-cases report. BMC Pediatr. 2025 Oct 2;25(1):738. doi: 10.1186/s12887-025-06118-1.

    PubMed 41039358

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing pCAR-19B cells in people with Acute Lymphoblastic Leukemia and Relapsed Pediatric ALL, run by Chongqing Precision Biotech Co., Ltd at 16 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 18 inclusion and 20 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 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Tianyou Wang, M.D (010-59616161, wangtianyou@bch.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate after pCAR-19B infusion [Effectiveness] (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05334823, which also lists 1 linked publication.

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 15 Sep 2026.

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