NCT04888442

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 26, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 17, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2022

Completed
Last Updated

May 17, 2021

Status Verified

May 1, 2021

Enrollment Period

1.3 years

First QC Date

May 12, 2021

Last Update Submit

May 12, 2021

Conditions

Acute Lymphoblastic Leukemia, in RelapseRefractory Acute Lymphoblastic Leukemia

Keywords

Adoptive T Cell TherapyChimeric antigen receptorCD19

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

  • +1 more secondary outcomes

Study Arms (1)

pCAR-19B cells

EXPERIMENTAL

Infusion of pCAR-19B cells by dose-escalating

Biological: pCAR-19B cells

Interventions

pCAR-19B cellsBIOLOGICAL

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

pCAR-19B cells

Eligibility Criteria

Age22 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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;
  • \~70 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;
  • +6 more criteria

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;
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Wuhan, Hubei, China

RECRUITING

Related Publications (1)

  • Li H, Ge T, Huang M, Zhang W, Li Z, Xiao M, Gao L. Application of metagenomic next-generation sequencing in bloodstream infection regarding immunosuppression. J Infect. 2023 May;86(5):508-512. doi: 10.1016/j.jinf.2023.02.008. Epub 2023 Feb 10. No abstract available.

    PMID: 36775248DERIVED

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune 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

Central Study Contacts

Xiaoxi zhou, M.D

CONTACT

86-27-83665027cello316@163.com

Liang Huang, M.D

CONTACT

86-27-63639810lhuang@tjh.tjmu.edu.cn

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

October 26, 2020

Primary Completion

January 30, 2022

Study Completion

March 28, 2022

Last Updated

May 17, 2021

Record last verified: 2021-05

Locations

CN(1)