A Study of ET-02 in Patients With Relapsed or Refractory... | NCT04933825

Studies
A Study of ET-02 in Patients With Relapsed or Refractory B-cell Malignancy(NHL/ALL)

NCT04933825

Sponsor

EdiGene (GuangZhou) Inc.

Status

Unknown status

Last Update Posted

Feb 17, 2023Actual

Enrollment

18Estimated

Phase

Not Applicable

Conditions

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

Interventions

ET-02

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 20, 2021Actual

Primary Completion Date

Sep 30, 2024Estimated

Completion Date

Sep 30, 2024Estimated

First Submitted Date

Jun 9, 2021

First Submission Date that Met QC Criteria

Jun 14, 2021

First Posted Date

Jun 22, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 15, 2023

Last Update Posted Date

Feb 17, 2023Actual

Name	Class
The First Affiliated Hospital of Henan University of Science and Technology	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Four escalating dose-levels of ET-02 will be evaluated using a "3+3" design.	Experimental		Biological: ET-02

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ET-02	Biological	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of adverse events	Adverse events assessed according to NCI-CTCAE v5.0 criteria	up to 2 years after lymphodepleting chemotherapy

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
•The First Affiliated Hospital of Henan University of Science and Technology		Luoyang	Henan	471003	China

Condition Browse Module

MeSH Terms

ID	Term
D012008	Recurrence

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided