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

NCT05334823 | Recruiting Phase 2

• 1 other identifier: PB07
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Acute Lymphoblastic Leukemia; Relapsed Pediatric ALL; Refractory Acute Lymphoblastic Leukemia

Keywords

CAR-T; CD19; B-ALL

Outcome Measures

Primary Outcomes (1)

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

  Objective response rate includes CR, CRi.

  3 months

Secondary Outcomes (16)

• Minimal residual disease（MRD）

  3 months

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

  2 years

• Overall survival after pCAR-19B infusion [Effectiveness]

  2 years

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

  2 years

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

  2 years

Other Outcomes (6)

• Comparative analysis of 6-month ORR of CAR-T treatment with or without hematopoietic stem cell transplantation

  6 months

• Assess the Children's growth and development after pCAR-19B infusion

  2 years

• Assess the Children's growth and development after pCAR-19B infusion

  2 years

Study Arms (1)

pCAR-19B cells

EXPERIMENTAL

Infusion of pCAR-19B cells by dose of 0.6-2 x106 cells/kg

Biological: pCAR-19B cells

Interventions

pCAR-19B cells BIOLOGICAL

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

pCAR-19B cells

Eligibility Criteria

• Age: 3 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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;
• 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；

Sponsors & Collaborators

• Chongqing Precision Biotech Co., Ltd: lead

Study Sites (10)

Beijing Children's Hospital.Capital Medical University

Beijing, Beijing Municipality, 100000, China

RECRUITING

Beijing GoBroad Boren Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

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

Wuhan, Hubei, 430000, China

RECRUITING

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

Wuhan, Hubei, 430000, China

RECRUITING

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

Wuhan, Hubei, 430000, China

RECRUITING

The Second Xiangya Hospital, Central South University

Changsha, Hunan, 410000, China

RECRUITING

Children's Hospital Of Soochow University

Suzhou, Jiangsu, 215000, China

RECRUITING

The First Affiliated Hospital Of Nanchang University

Nanchang, Jiangxi, 330000, China

RECRUITING

West China Second University Hospital,Sichuan University

Chengdu, Sichuan, 610000, China

RECRUITING

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

Tianjin, Tianjin Municipality, 300000, China

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Tianyou Wang, M.D. Ph.D

  Beijing Children's Hospital

  PRINCIPAL INVESTIGATOR

• Yicheng Zhang, M.D. Ph.D

  Tongji Hospital, Affiliated to Tongji Medical College of Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tianyou Wang, M.D

CONTACT

010-59616161; wangtianyou@bch.com.cn

Yicheng Zhang, M.D

CONTACT

18607140317; yczhang@tjh.tjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: April 19, 2022
• Study Start: January 26, 2022
• Primary Completion: December 31, 2024
• Study Completion: July 1, 2025
• Last Updated: July 31, 2024

Record last verified: 2024-07

Locations

CN (10)