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.
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
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Relapsed Pediatric ALL, Refractory Acute Lymphoblastic Leukemia
- 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
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.
16 sites in 1 country
China16 sites, 16 recruiting
- 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
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.
- Conditions
- Acute Lymphoblastic Leukemia, Relapsed Pediatric ALL, Refractory Acute Lymphoblastic Leukemia
- 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 group | Role | What they receive |
|---|---|---|
| pCAR-19B cells | Experimental | Infusion 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.
Objective response rate after pCAR-19B infusion [Effectiveness]
Objective response rate includes CR, CRi.
Measured: 3 months
Secondary outcomes (16)
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
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
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
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
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
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):
- Death from any cause after remission;
- Disease recurrence;
- Withdrawal from the clinical trial after treatment failure or meeting the withdrawal criteria.
Measured: 2 years
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
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
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:
- Cytokine release syndrome (CRS) of grade 3 and above;
- Immune effector cell-associated neurotoxicity syndrome (ICANS) of grade 3 and above;
- Grade 3 and above infection;
- Grade 3 and above acute tumor lysis syndrome;
- Unresolved cytopenias lasting 28 days.
Measured: 2 years
the incidence of RCL of pCAR-19B infusion
RCL Detection: the incidence of Replication Competent Lentivirus.
Measured: 2 years
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
Pharmacokinetic data parameters of Tmax
Analysis using CAR DNA copy number measured by qPCR: the time to reach the highest concentration;
Measured: 3 months
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
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
Pharmacodynamics data parameters of CAR-T-related serum cytokines
the concentration levels of IL-6 at each time point.
Measured: 3 months
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.
- First posted19 Apr 2022
- Study start26 Jan 2022
- Primary completion31 Dec 2028 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing Precision Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tianyou Wang, M.D. Ph.D, Principal investigator, Beijing Children's HospitalYicheng Zhang, M.D. Ph.D, Principal investigator, Tongji Hospital
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