A Phase 2 interventional study of pCAR-19B cells in Acute Lymphoblastic Leukemia, Relapsed Pediatric ALL and Refractory Acute Lymphoblastic Leukemia, sponsored by Chongqing Precision Biotech Co., Ltd. Recruiting at 16 sites in China. Open to participants aged 3 Years to 21 Years. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Chongqing Precision Biotech Co., Ltd · Phase 2, Interventional, and Treatment
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.
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.
2,061 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 490 are open to participants now.
This study's planned enrollment of 100 is above the median of 40 across 1,653 interventional studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.
Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →Chongqing Precision Biotech Co., Ltd is the lead sponsor of 51 studies on the registry; 37 are open to participants now.
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Diagnosed with B-ALL，and meet one of the following conditions:
The function of important organs is basically normal:
Exclusion Criteria:
Have any of the following heart conditions:
Infusion of pCAR-19B cells by dose of 0.6-2 x10\^6 cells/kg
Biological: pCAR-19B cells
Drug: pCAR-19B cells； Administration method: intravenous infusion； Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion.
Objective response rate after pCAR-19B infusion [Effectiveness]
Objective response rate includes CR, CRi.
Time frame: 3 months
Minimal residual disease（MRD）
MRD-negative ORR within 3 months by flow cytometry as assessed by Independent Review Committee (IRC) and investigator.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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): 1. Death from any cause after remission; 2. Disease recurrence; 3. Withdrawal from the clinical trial after treatment failure or meeting the withdrawal criteria.
Time frame: 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
Time frame: 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
Time frame: 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: 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.
Time frame: 2 years
the incidence of RCL of pCAR-19B infusion
RCL Detection: the incidence of Replication Competent Lentivirus.
Time frame: 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
Time frame: 3 months
Pharmacokinetic data parameters of Tmax
Analysis using CAR DNA copy number measured by qPCR: the time to reach the highest concentration;
Time frame: 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.
Time frame: 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
Time frame: 3 months
Pharmacodynamics data parameters of CAR-T-related serum cytokines
the concentration levels of IL-6 at each time point.
Time frame: 3 months
Immunogenicity of pCAR-19B cells
Analysis using anti-CAR antibodies measured by Meso Scale Discovery（Electrochemiluminescence）
Time frame: 3 months
Comparative analysis of 6-month ORR of CAR-T treatment with or without hematopoietic stem cell transplantation
Independent Review Committee (IRC) and investigator-assessed 6-month ORR, including CR and CRi; Independent Review Committee (IRC) and investigator-assessed 6-month ORR with MRD-negative, including CR and CRi.
Time frame: 6 months
Assess the Children's growth and development after pCAR-19B infusion
The subject's height were measured before infusion and 1, 2, 3 months after infusion and every three months thereafter.
Time frame: 2 years
Assess the Children's growth and development after pCAR-19B infusion
The subject's weight were measured before infusion and 1, 2, 3 months after infusion and every three months thereafter.
Time frame: 2 years
The impact of the cellular and molecular features of immune function statu on response and adverse reactions
The correlation between the detection results of peripheral blood lymphocyte subsets which measured by Cellular immunoassay and the efficacy and safety.
Time frame: 3 months
Comparative analysis of 6-month RFS of CAR-T treatment with or without hematopoietic stem cell transplantation
6-month relapse-free survival (RFS) by Independent Review Committee (IRC) and investigator assessments was statistically compared between the two groups; Relapse free survival means time from subject infusion of pCAR-19B cells to first disease relapse or death from any cause (whichever occurs first).
Time frame: 6 months
Comparative analysis of 6-month OS of CAR-T treatment with or without hematopoietic stem cell transplantation
6-month Overall survival (OS) by Independent Review Committee (IRC) and investigator assessments was statistically compared between the two groups; Overall survival means the time from infusion of pCAR-19B cells to death of subjects from any cause
Time frame: 6 months
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Chongqing Precision Biotech Co., Ltd