Dual-target CAR-T CellsPhase 1/2CAR-TNCT04723901
Dual Target CAR-T Cells in B-cell Acute Lymphoblastic Leukemia
A Phase 1/2 study testing Dual target CAR-T cell therapy in people with Dual-target CAR-T Cells and B ALL, run by Shenzhen University General Hospital at 1 site in China.
Trial summary
Prospectively evaluate the safety and effectiveness of CD19/CD22 dual-target CAR-T cells in the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia. Read more about this study
- Who is it for?
- Ages 14 to 75 years
- Conditions the study is for
- Dual-target CAR-T Cells, B ALL, Relapse
- What is being tested?
- Dual target CAR-T cell therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2020to 31 Dec 2022
- Phase
- Phase 1/2
- 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 14 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects must meet the following criteria to participate in this study:
- 14-75 years old, no gender limit;
- According to the 2020 World Health Organization (WHO) diagnostic criteria, it is diagnosed as relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL);
- ECOG behavior status score is 0-2 points;
- Expected survival time ≥ 3 months;
- No contraindications to peripheral apheresis;
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- Flow cytometry confirms that the original cells express CD22;
- Those who are tolerant to CD19 CAR-T cell therapy or those with low CD19 expression;
- No serious heart, lung, liver or kidney disease;
- Ability to understand and willing to sign the informed consent form for this trial.
Who cannot join
- Patients with any of the following cannot be included in this study:
- The original cells expressing CD19 and CD22 are negative;
- There is active infection;
- Abnormal liver function ( glutamic-pyruvic transaminase>1.5×ULN, glutamic oxalacetic transaminase>2.5×ULN), abnormal renal function (serum creatinine>1.5×ULN);
- People with unstable angina or New York Heart Association class 3/4 congestive heart failure, multiple organ dysfunction;
- HIV/AIDS patients;
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- Those who need long-term anticoagulation (warfarin or heparin), antiplatelet (aspirin, dose>300mg/d; clopidogrel, dose>75mg/d) treatment;
- Those who received radiotherapy within 4 weeks before the start of the study (blood sampling);
- Known or suspected drug abuse or alcohol dependence;
- People with mental illness or other conditions cannot obtain informed consent, and cannot cooperate with the requirements for completing the experimental treatment and inspection procedures;
- Those who have participated in other clinical trials within 30 days;
- Pregnant or lactating women, male subjects (or their partners) or female subjects have a pregnancy plan during the study period to 6 months after the end of the test, and are unwilling to use a medically approved effective contraceptive measure during the test period (Such as intrauterine device or condom);
- The investigator judged that it is not suitable to participate in this trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shenzhen University General hospital
Shenzhen, Guangdong, 518055
Shujiao He, Dr, +86-0755-2183-9178, he_shujiao@126.com
About this study
Official title: Clinical Trial of CD19/CD22 Dual Target CAR-T Cells in the Treatment of Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia
Prospectively evaluate the safety and effectiveness of CD19/CD22 dual-target CAR-T cells in the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia.
Read the detailed description
Prospectively evaluate the safety and effectiveness of CD19/CD22 dual-target CAR-T cells in the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia. Strictly follow the inclusion criteria to screen eligible subjects for inclusion in clinical trials. The selected patients received CD19/CD22 dual-target CAR-T cell therapy. After the treatment is over, follow-up regularly to determine the survival status and follow-up treatment.
- Being tested
- Dual target CAR-T cell therapy
- Medical subject headings
- Recurrence, Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual target CAR-T cell therapyBiological
CD19/CD22 dual target CAR-T cell therapy
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Dual target CAR-T cell therapy Receives: Biological: Dual target CAR-T cell therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete remission rate
- No blasts in peripheral blood, no extramedullary leukemia;
- Three-line bone marrow hematopoietic recovery, primitive cells <5%;
- Peripheral blood absolute neutrophil count>1.0×10^9/L;
- Peripheral blood platelet count>100×10^9/L;
- No recurrence within 4 weeks
Measured: From date of initial treatment to the end of follow up, up to 2 years
Secondary outcomes (1)
Overall survival rate
The proportion of surviving patients at the end of the study.
Measured: From admission to the end of follow up, up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start20 Oct 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dual-target CAR-T CellsStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen University General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YuLi, Shenzhen University General Hospital
- Investigators
- Li Yu, Dr, Principal investigator, Shenzhen University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04723901
- Sponsor's protocol ID
- HEM-ONCO-005
- Acronym
- CAR-T
- Status last verified
- Jan 2021
- First submitted
- 21 Jan 2021
- Last updated
- 26 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no intention
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of CD19/CD22 Dual Target CAR-T Cells in the Treatment of Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT04723901
- Acronym / sponsor ID
- CAR-T / HEM-ONCO-005
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shenzhen University General HospitalUniversity, hospital or other
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 26 Jan 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.
Prospectively evaluate the safety and effectiveness of CD19/CD22 dual-target CAR-T cells in the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia.
Detailed description
Prospectively evaluate the safety and effectiveness of CD19/CD22 dual-target CAR-T cells in the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia. Strictly follow the inclusion criteria to screen eligible subjects for inclusion in clinical trials. The selected patients received CD19/CD22 dual-target CAR-T cell therapy. After the treatment is over, follow-up regularly to determine the survival status and follow-up treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Biological: Dual target CAR-T cell therapyDual target CAR-T cell therapy |
Who may qualify
- Ages
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects must meet the following criteria to participate in this study:
Key exclusion criteria (13 listed)
- Patients with any of the following cannot be included in this study:
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 |
|---|---|---|
| Dual target CAR-T cell therapyCD19/CD22 dual target CAR-T cell therapy | Biological | Treatment group |
Primary outcome
Complete remission rate
Time frame: From date of initial treatment to the end of follow up, up to 2 years
1. No blasts in peripheral blood, no extramedullary leukemia; 2. Three-line bone marrow hematopoietic recovery, primitive cells <5%; 3. Peripheral blood absolute neutrophil count>1.0×10^9/L; 4. Peripheral blood platelet count>100×10^9/L; 5. No recurrence within 4 weeks
1 secondary outcome
Overall survival rate
Time frame: From admission to the end of follow up, up to 2 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
- Individual participant dataSharing planned: No. no intention
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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.
Li Yu, Dr principal investigator
Shenzhen University General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Dual target CAR-T cell therapy in people with Dual-target CAR-T Cells and B ALL, run by Shenzhen University General Hospital 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 10 inclusion and 13 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 26 Jan 2021. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 shujiao he, Dr (+86-0755-21839178, he_shujiao@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete remission rate (time frame: From date of initial treatment to the end of follow up, up to 2 years). 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 26 Jan 2021; AzTrials last refreshed its copy on 6 Nov 2026.