A Study of pCAR-19B in the Treatment of CD19-positive Relapsed/Refractory B-ALL in Children and Adolescents
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age3-21
SponsorChongqing Precision Biotech Co., Ltd
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
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);
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
pCAR-19B cells
Biological/VaccineDrug: pCAR-19B cells； Administration method: intravenous infusion； Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: pCAR-19B cellsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective response rate after pCAR-19B infusion [Effectiveness]
Objective response rate includes CR, CRi.
Time frame
3 monthsSecondary outcomes
1
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 months2
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 years3
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 years4
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 yearsOther outcomes
1
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 months2
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 years3
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 years4
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 monthsSponsors and contacts
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Source ClinicalTrials.gov