NCT04740203

Brief Summary

Clinical Trial for the Safety and Efficacy of Sequential CD19 and CD22 CAR-T Therapy for Adult Patients With Newly Diagnosed Ph Chromosome Negative B-cell Acute Lymphoblastic Leukemia

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
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2021

Longer than P75 for phase_1

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

First Submitted

Initial submission to the registry

January 31, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

January 31, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 5, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

February 5, 2021

Status Verified

February 1, 2021

Enrollment Period

3 years

First QC Date

January 31, 2021

Last Update Submit

February 4, 2021

Conditions

B-Cell Acute Lymphoblastic Leukemia, Adult

Keywords

CD19 CAR-TCD22 CAR-TPh Chromosome NegativeB-ALLNewly diagnosed

Outcome Measures

Primary Outcomes (2)

  • Dose-limiting toxicity (DLT)

    Adverse events assessed according to NCI-CTCAE v5.0 criteria

    Baseline up to 28 days after CAR-T cells infusion

  • Incidence of treatment-emergent adverse events (TEAEs)

    Incidence of treatment-emergent adverse events \[Safety and Tolerability\]

    Up to 2 years after CAR-T cells infusion

Secondary Outcomes (4)

  • Complete Remission Rate

    up to 28 days after CAR-T cells infusion

  • Overall survival (OS)

    Up to 2 years after CD19 CAR-T cells infusion

  • Leukemia-free survival (LFS)

    Up to 2 years after CD19 CAR-T cells infusion

  • Quality of life

    At Baseline, Month 1, 3, 6, 9 and 12

Study Arms (1)

CAR-T therapy

EXPERIMENTAL

Administration of CD19 and CD22 CAR T-cells

Drug: CAR-T cells targeting CD19 and CD22

Interventions

CAR-T cells targeting CD19 and CD22DRUG

Each subject receives sequential CD19 and CD22 CAR-T cells by intravenous infusion

CAR-T therapy

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age≥15 years old
  • Newly diagnosed B-cell acute lymphoblastic leukemia according to the 2016 WHO classification
  • The immunophenotype of leukemia cells were CD19 and CD22 positive
  • Ph- or Ph- like negative
  • Anticipated survival time more than 12 weeks;
  • Those who voluntarily participated in this trial and provided informed consent.

You may not qualify if:

  • History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;
  • Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
  • Pregnant (or lactating) women;
  • Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
  • Active infection of hepatitis B virus or hepatitis C virus;
  • Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving inhaled steroids;
  • Previously treated with any CAR-T cell product or other genetically-modified T cell therapies;
  • Creatinine\>2.5mg/dl, or ALT / AST \> 3 times of normal amounts, or bilirubin\>2.0 mg/dl;
  • Other uncontrolled diseases that were not suitable for this trial;
  • Patients with HIV infection;
  • Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Burkitt Lymphoma

Condition Hierarchy (Ancestors)

Epstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Central Study Contacts

He Huang, PhD

CONTACT

86-13605714822hehuangyu@126.com

Mingming Zhang, PhD

CONTACT

86-13656674208mingmingzhang@zju.edu.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 31, 2021

First Posted

February 5, 2021

Study Start

January 31, 2021

Primary Completion

January 31, 2024

Study Completion

January 31, 2025

Last Updated

February 5, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)