Relapsed or Refractory B-cell Malignancy(NHL/ALL)NCT04933825
A Study of ET-02 in Patients With Relapsed or Refractory B-cell Malignancy(NHL/ALL)
A study testing ET-02 in people with Relapsed or Refractory B-cell Malignancy(NHL/ALL), run by EdiGene (GuangZhou) Inc. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed or Refractory B-cell Malignancy(NHL/ALL)
- What is being tested?
- ET-02
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2021to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
•The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471003
About this study
Official title: An Exploratory,Open-label,and Single Center Study to Evaluate the Safety and Efficacy of ET-02 in Patients With Relapsed or Refractory B-cell Malignancies(NHL/ALL).
The purpose of this study is to evaluate the safety and efficacy of CD19-UCART in patients with r/r B-cell hematological malignancies.
- Being tested
- ET-02
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ET-02Biological
A conditioning therapy with cyclophosphamide and fludarabine will be conducted before ET-02 injection.
| Study group | Role | What they receive |
|---|---|---|
| Four escalating dose-levels of ET-02 will be evaluated using a "3+3" design. | Experimental | Not described Receives: Biological: ET-02 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Measured: up to 2 years after lymphodepleting chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start20 Jul 2021
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory B-cell Malignancy(NHL/ALL)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EdiGene (GuangZhou) Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Henan University of Science and Technology
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04933825
- Sponsor's protocol ID
- EDI-002
- Status last verified
- Feb 2023
- First submitted
- 9 Jun 2021
- Last updated
- 17 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory,Open-label,and Single Center Study to Evaluate the Safety and Efficacy of ET-02 in Patients With Relapsed or Refractory B-cell Malignancies(NHL/ALL).
- ClinicalTrials.gov ID
- NCT04933825
- Acronym / sponsor ID
- EDI-002
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- EdiGene (GuangZhou) Inc.Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Henan University of Science and Technology
- Study start
- 20 Jul 2021 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 22 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and efficacy of CD19-UCART in patients with r/r B-cell hematological malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Four escalating dose-levels of ET-02 will be evaluated using a "3+3" design. | Experimental | Biological: ET-02 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ET-02A conditioning therapy with cyclophosphamide and fludarabine will be conducted before ET-02 injection. | Biological | Four escalating dose-levels of ET-02 will be evaluated using a "3+3" design. |
Primary outcome
Incidence of adverse events
Time frame: up to 2 years after lymphodepleting chemotherapy
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ET-02 in people with Relapsed or Refractory B-cell Malignancy(NHL/ALL), run by EdiGene (GuangZhou) Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: up to 2 years after lymphodepleting chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2023.