Status unknownNCT04933825Updated Feb 17, 2023

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

An interventional study of ET-02 in Relapsed or Refractory B-cell Malignancy(NHL/ALL), sponsored by EdiGene (GuangZhou) Inc.. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-17.

Sponsored by EdiGene (GuangZhou) Inc. · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2023), so the status shown — last known as Active, not recruiting — may be out of date.

Phase: Not applicable
Study type: Interventional
Enrollment: 18
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

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

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Neoplasms 9,365

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 18 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

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Lead sponsor

EdiGene (GuangZhou) Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 18 participants (estimated)

Study arms

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

Interventions

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

What researchers measure

Primary outcomes

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

Study locations

1 site

•The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan 471003, China

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 17, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04933825
Lead sponsor: EdiGene (GuangZhou) Inc.
Collaborators: The First Affiliated Hospital of Henan University of Science and Technology
Responsible party: Sponsor
First posted: Jun 22, 2021
Start date: Jul 20, 2021
Primary completion: Sep 30, 2024 (estimated)
Completion: Sep 30, 2024 (estimated)
Last update: Feb 17, 2023

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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