Relapsed/Refractory AMLPhase 2/3NCT03631576
CD123/CLL1 CAR-T Cells for R/R AML (STPHI_0001)
A Phase 2/3 study testing CD123/CLL1 CAR-T Cells in people with Relapsed/Refractory AML, run by Fujian Medical University at 1 site in China.
Trial summary
The treatment options for relapse/refractory B-cell acute myeloid leukemia(AML)are limited.CD123/CLL1 CAR-T Cells may have a permanent anti-tumor effect and became very attractive. This study aims to assess the safety and toxicity of CD123/CLL1 CAR-T Cells to patients with relapse/refractory AML. Read more about this study
- Who is it for?
- Ages Up to 70 years
- Conditions the study is for
- Relapsed/Refractory AML
- What is being tested?
- CD123/CLL1 CAR-T Cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2018to 10 Aug 2021
- Phase
- Phase 2/3
- 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 Up to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Signed written informed consent
- Aged < 70 years
- Patients with relapsed/refractory AML
- Cardiac: Left ventricular ejection fraction ≥ 50%
- Adequate renal and hepatic function
- Performance status: Karnofsky ≥ 70%
Who cannot join
- Pregnant or lactating females.
- Any co-morbidity precluding the administration of CD123/CLL1 CAR-T Cells.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Jianda Hu, Prof., 86-13959169016, drjiandahu@163.com
Ting Yang, Prof., 86-13950210357, yang.hopeting@gmail.com
About this study
Official title: CD123/CLL1 CAR-T Cell Therapy for Relapsed and Refractory Acute Myeloid Leukemia
The treatment options for relapse/refractory B-cell acute myeloid leukemia(AML)are limited.CD123/CLL1 CAR-T Cells may have a permanent anti-tumor effect and became very attractive. This study aims to assess the safety and toxicity of CD123/CLL1 CAR-T Cells to patients with relapse/refractory AML.
- Conditions
- Relapsed/Refractory AML
- Being tested
- CD123/CLL1 CAR-T Cells
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD123/CLL1 CAR-T CellsBiological
CD123/CLL1 CAR-T Cell Therapy
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | CD123/CLL1 CAR-T Cells treat Receives: Biological: CD123/CLL1 CAR-T Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leukemia free survival
Measured: 1 year
Secondary outcomes (1)
Adverse events that are related to treatment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start10 Aug 2018
- Primary completion10 Aug 2021 (estimated)
- Study completion10 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory AMLStudies of the same condition, open and under way.
- More trials run by Fujian Medical UniversityThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianda Hu, Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03631576
- Sponsor's protocol ID
- CART-19-04
- Status last verified
- Dec 2019
- First submitted
- 13 Aug 2018
- Last updated
- 2 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CD123/CLL1 CAR-T Cell Therapy for Relapsed and Refractory Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT03631576
- Acronym / sponsor ID
- CART-19-04
- Conditions
- Relapsed/Refractory AML
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 10 Aug 2018 (actual)
- Primary completion
- 10 Aug 2021 (estimated)
- Study completion
- 10 Aug 2021 (estimated)
- First posted
- 15 Aug 2018 (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 treatment options for relapse/refractory B-cell acute myeloid leukemia(AML)are limited.CD123/CLL1 CAR-T Cells may have a permanent anti-tumor effect and became very attractive. This study aims to assess the safety and toxicity of CD123/CLL1 CAR-T Cells to patients with relapse/refractory AML.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Biological: CD123/CLL1 CAR-T CellsCD123/CLL1 CAR-T Cells treat |
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Signed written informed consent
- Aged < 70 years
- Patients with relapsed/refractory AML
- Cardiac: Left ventricular ejection fraction ≥ 50%
- Adequate renal and hepatic function
Key exclusion criteria (2 listed)
- Pregnant or lactating females.
- Any co-morbidity precluding the administration of CD123/CLL1 CAR-T Cells.
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 |
|---|---|---|
| CD123/CLL1 CAR-T CellsCD123/CLL1 CAR-T Cell Therapy | Biological | Arm 1 |
Primary outcome
Leukemia free survival
Time frame: 1 year
1 secondary outcome
Adverse events that are related to treatment
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing CD123/CLL1 CAR-T Cells in people with Relapsed/Refractory AML, run by Fujian Medical University 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 2 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 2 Jan 2020. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Jianda Hu, Prof.M.D.Ph.D (86-13959169016, drjiandahu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leukemia free survival (time frame: 1 year). 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 2 Jan 2020.