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

NCT04888468 | Completed Phase 1

• 1 other identifier: PB01
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase I clinical study to evaluate the safety and tolerability of pCAR-19B in patients with relapsed or refractory B-ALL, and to obtain the maximum tolerated dose of pCAR-19B and phase II Recommended dose.

Conditions

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

Keywords

CAR-T; CD19; B-ALL

Outcome Measures

Primary Outcomes (2)

• Incidence of Adverse events after pCAR-19B infusion [Safety and Tolerability]

  Therapy-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)

  28 days

• Obtain the maximum tolerated dose of pCAR-19B cells[Safety and Tolerability]

  Dose-limiting toxicity after cell infusion

  28 days

Secondary Outcomes (6)

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

  3 months

• AUCS of pCAR-19B cells [Cell dynamics]

  3 months

• CMAX of pCAR-19B cells [Cell dynamics]

  3 months

• TMAX of pCAR-19B cells [Cell dynamics]

  3 months

• Pharmacodynamics of pCAR-19B cells[Cell dynamics]

  3 months

Study Arms (1)

pCAR-19B cells

EXPERIMENTAL

Infusion of pCAR-19B cells by dose-escalating

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:

• Diagnosed with B-ALL，and meet one of the following conditions:
• First-line or multiple-line salvage chemotherapy did not achieve complete remission；
• Early relapse after complete remission (\<12 months), or late relapse after complete remission (≥12 months) and complete remission has not been achieved after 1 course of treatment；
• Relapse after autologous or allogeneic hematopoietic stem cell transplantation;
• Ph+ALL patients should also receive at least two TKI treatments；
• For allogeneic hematopoietic stem cell transplant subjects, the following conditions must be met：
• Allo-HSCT takes ≥6 months before pCAR-19B infusion；
• No GVHD of grade 2 or above occurred within 2 weeks before PBMC collection;
• Express CD19;
• \~21 years old, no gender limit;
• The expected survival time is more than 12 weeks;
• KPS\>60;
• No serious mental disorders;
• The function of important organs is basically normal:
• Heart function: echocardiography indicates that the cardiac ejection fraction is ≥50%, and the electrocardiogram has no obvious abnormalities;

You may not qualify if:

• With central nervous system disease at the time of screening;
• Have received CAR-T therapy or other genetically modified cell therapy;
• Participated in other clinical studies within 1 month before screening;
• Have received the following anti-tumor treatments before screening: received chemotherapy, targeted therapy or other experimental drug treatments within 14 days or at least 5 half-lives (whichever is shorter);
• Have received a live attenuated vaccine within 4 weeks before screening;
• Cerebrovascular accident or seizure occurred within 6 months before signing the ICF;
• Suffered from any of the following heart diseases:
• NYHA stage III or IV congestive heart failure;
• Myocardial infarction or CABG occurred ≤6 months before enrollment;
• Clinically significant ventricular arrhythmia, or history of unexplained syncope (except for cases caused by vasovagal or dehydration);
• History of severe non-ischemic cardiomyopathy.
• Uncontrollable infection in the 2 weeks 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；
• HBsAg or HBcAb positive and HBV DNA is greater than the normal range; HCV antibody is positive and HCV RNA greater than the normal range; HIV antibody positive; syphilis positive; CMV DNA positive;

Sponsors & Collaborators

• Chongqing Precision Biotech Co., Ltd: lead

Study Sites (1)

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

Wuhan, Hubei, China

Location

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

• Jianfeng Zhou, M.D. Ph.D

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: May 17, 2021
• Study Start: November 5, 2019
• Primary Completion: June 29, 2021
• Study Completion: September 1, 2021
• Last Updated: March 18, 2022

Record last verified: 2021-05

Locations

CN (1)