NCT04933825

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of CD19-UCART in patients with r/r B-cell hematological malignancies.

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 below P25 for not_applicable

Timeline
Completed

Started Jul 2021

Typical duration for not_applicable

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

June 9, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 22, 2021

Completed
28 days until next milestone

Study Start

First participant enrolled

July 20, 2021

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

February 17, 2023

Status Verified

February 1, 2023

Enrollment Period

3.2 years

First QC Date

June 9, 2021

Last Update Submit

February 15, 2023

Conditions

Relapsed or Refractory B-cell Malignancy(NHL/ALL)

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse events

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

    up to 2 years after lymphodepleting chemotherapy

Study Arms (1)

Four escalating dose-levels of ET-02 will be evaluated using a "3+3" design.

EXPERIMENTAL
Biological: ET-02

Interventions

ET-02BIOLOGICAL

A conditioning therapy with cyclophosphamide and fludarabine will be conducted before ET-02 injection.

Four escalating dose-levels of ET-02 will be evaluated using a "3+3" design.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients volunteer to participate in the study and sign the ICF;
  • Male or female aged≥18 years old；
  • Patient with relapsed or refractory CD19 positive B-ALL orNHL，as evidenced by 2 or more lines of prior therapy ;
  • Estimated life expectancy≥12 weeks ;
  • ECOG performance status ≤1;
  • Adequate organ function.

You may not qualify if:

  • Patients with graft-versus-host disease (GVHD) or requiring immunosuppressive therapy；
  • History of central nervous system (CNS) involvement by malignancy；
  • Women who are pregnant or breastfeeding；
  • Any situations that may increase the risk of patients or interfere with the results of study，which judged by investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

•The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, 471003, China

Location

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2021

First Posted

June 22, 2021

Study Start

July 20, 2021

Primary Completion

September 30, 2024

Study Completion

September 30, 2024

Last Updated

February 17, 2023

Record last verified: 2023-02

Locations

CN(1)