B-Cell Acute Lymphoblastic Leukemia, AdultPhase 2NCT04788472
Sequential CD19 and CD22 CAR-T Therapy for Newly Diagnosed Ph+ B-ALL
A Phase 2 study testing CAR-T cells targeting CD19 and CD22 in people with B-Cell Acute Lymphoblastic Leukemia, Adult, run by Zhejiang University at 1 site in China.
Trial summary
Clinical Trial for the Efficacy and Safety of Sequential CD19 and CD22 CAR-T Therapy for Adult Patients With Newly Diagnosed Ph Chromosome Positive B-cell Acute Lymphoblastic Leukemia Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B-Cell Acute Lymphoblastic Leukemia, Adult
- What is being tested?
- CAR-T cells targeting CD19 and CD22
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 5 Mar 2021to 31 Aug 2024
- Phase
- Phase 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old;
- Subjects with a diagnosis of B-cell acute lymphoblastic leukemia according to the 2016 edition of the WHO classification criteria for acute leukemia;
- Subjects whose chromosomal and fusion gene analysis showed positivity for the Ph chromosome, BCR/ABL1 fusion gene;
- Leukemia cells were CD19 and CD22 positive;
- Patients with newly diagnosed B-ALL were not treated with standard chemotherapy regimens;
- Serum total bilirubin ≤ 51 mol/L, serum ALT and AST both ≤ 3 times the upper limit of the normal range, blood creatinine ≤ 176.8 mol/L;
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- Echocardiography showed a left ventricular ejection fraction (LVEF) ≥50%;
- Subjects had no active pulmonary infection and oxygen saturation ≥92% without oxygen;
- The prognosis for survival is more than 3 months;
- ECOG score 0-2;
- Subjects volunteered to participate in this trial and signed an informed consent form.
Who cannot join
- Subjects with any of the following exclusion criteria were not eligible for enrollment in this trial:
- Those with a history of epilepsy or other central nervous system disorders;
- Those with a history of prolonged QT period or severe cardiac disease;
- Women who are pregnant or breastfeeding (the safety of this therapy for the unborn child is not known);
- Those with uncontrolled active infection;
- Active hepatitis B or hepatitis C virus infection;
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- Those who have previously used any gene therapy product;
- Those with insufficient amplification (<5-fold) in response to CD3/CD28 co-stimulatory signals;
- Creatinine > 2.5 mg/dl or ALT / AST > 3 times the upper limit of the normal range or bilirubin > 2.0 mg/dl;
- Those who suffer from other uncontrolled medical conditions that, in the opinion of the investigator, make them unsuitable for enrollment;
- HIV-infected persons;
- Any condition that, in the opinion of the investigator, may increase the risk to the subject or interfere with the results of the test.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003
About this study
Official title: Clinical Trial for the Efficacy and Safety of Sequential CD19 and CD22 CAR-T Therapy for Adult Patients with Newly Diagnosed Ph Chromosome Positive B-cell Acute Lymphoblastic Leukemia
Clinical Trial for the Efficacy and Safety of Sequential CD19 and CD22 CAR-T Therapy for Adult Patients With Newly Diagnosed Ph Chromosome Positive B-cell Acute Lymphoblastic Leukemia
Read the detailed description
This study was designed as a prospective, open-label, single-center study. It aims to evaluate the efficacy and safety of CD19 CAR-T cells in combination with dasatinib for the treatment of newly diagnosed Ph-positive B-cell acute lymphoblastic leukemia in adult.
- Being tested
- CAR-T cells targeting CD19 and CD22
- Keywords
- CD19 CAR-T, CD22 CAR-T, Ph Chromosome Positive, B-ALL, Newly diagnosed
- Medical subject headings
- Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR-T cells targeting CD19 and CD22Drug
Each subject receives sequential CD19 and CD22 CAR-T cells by intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| CAR-T therapy | Experimental | Administration of CD19 and CD22 CAR T-cells Receives: Drug: CAR-T cells targeting CD19 and CD22 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete molecular response (CMR) rate
Complete molecular response (CMR) rate after CD19 CAR-T cell therapy
Measured: Up to 1 month after CAR-T cells infusion
Secondary outcomes (6)
Complete molecular response (CMR) rate
Complete molecular response (CMR) rate after CD22 CAR-T cell therapy
Measured: Up to 1 month after CAR-T cells infusion
Leukemia-free survival (LFS)
From the complete remission to the occurrence of any event, including death, relapse (any one occurs first), and the last visit
Measured: Up to 2 years after CD19 CAR-T cells infusion
Overall survival (OS)
From the first infusion of CD19 CAR-T cells to death or the last visit
Measured: Up to 2 years after CD19 CAR-T cells infusion
cumulative incidence of relapse (CIR)
From the complete remission to relapse
Measured: Up to 2 years after CD19 CAR-T cells infusion
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of treatment-emergent adverse events (Safety and Tolerability)
Measured: Through study completion, an average of 2 years
Characterization of relapse
Including expression of CD19, CD22 and mutations in the ABL1 gene
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start5 Mar 2021
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for B-Cell Acute Lymphoblastic Leukemia, AdultStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Yake Biotechnology Ltd.
- Responsible party
- Principal investigator, He Huang, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04788472
- Sponsor's protocol ID
- CD19-006
- Status last verified
- Oct 2024
- First submitted
- 5 Mar 2021
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang M, Fu S, Feng J, Hong R, Wei G, Zhao H, Zhao M, Xu H, Cui J, Huang S, Wu X, Liu L, Sun J, Wu W, Zhu Y, He J, Zhao Y, Cai Z, Zheng W, Ye X, Shi J, Luo Y, Wang D, Chang AH, Hu Y, Huang H. Dasatinib and CAR T-Cell Therapy in Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia: A Nonrandomized Clinical Trial. JAMA Oncol. 2025 Jun 1;11(6):625-629. doi: 10.1001/jamaoncol.2025.0674.
PubMed 40244598
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial for the Efficacy and Safety of Sequential CD19 and CD22 CAR-T Therapy for Adult Patients with Newly Diagnosed Ph Chromosome Positive B-cell Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT04788472
- Acronym / sponsor ID
- CD19-006
- Keywords
- CD19 CAR-T, CD22 CAR-T, Ph Chromosome Positive, B-ALL, Newly diagnosed
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Yake Biotechnology Ltd.
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 9 Mar 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.
Clinical Trial for the Efficacy and Safety of Sequential CD19 and CD22 CAR-T Therapy for Adult Patients With Newly Diagnosed Ph Chromosome Positive B-cell Acute Lymphoblastic Leukemia
Detailed description
This study was designed as a prospective, open-label, single-center study. It aims to evaluate the efficacy and safety of CD19 CAR-T cells in combination with dasatinib for the treatment of newly diagnosed Ph-positive B-cell acute lymphoblastic leukemia in adult.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAR-T therapy | Experimental | Drug: CAR-T cells targeting CD19 and CD22Administration of CD19 and CD22 CAR T-cells |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥ 18 years old;
- Subjects with a diagnosis of B-cell acute lymphoblastic leukemia according to the 2016 edition of the WHO classification criteria for acute leukemia;
- Subjects whose chromosomal and fusion gene analysis showed positivity for the Ph chromosome, BCR/ABL1 fusion gene;
- Leukemia cells were CD19 and CD22 positive;
- Patients with newly diagnosed B-ALL were not treated with standard chemotherapy regimens;
Key exclusion criteria (12 listed)
- Subjects with any of the following exclusion criteria were not eligible for enrollment in this trial:
- Those with a history of epilepsy or other central nervous system disorders;
- Those with a history of prolonged QT period or severe cardiac disease;
- Women who are pregnant or breastfeeding (the safety of this therapy for the unborn child is not known);
- Those with uncontrolled active infection;
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 |
|---|---|---|
| CAR-T cells targeting CD19 and CD22Each subject receives sequential CD19 and CD22 CAR-T cells by intravenous infusion | Drug | CAR-T therapy |
Primary outcome
Complete molecular response (CMR) rate
Time frame: Up to 1 month after CAR-T cells infusion
Complete molecular response (CMR) rate after CD19 CAR-T cell therapy
6 secondary outcomes
Complete molecular response (CMR) rate
Time frame: Up to 1 month after CAR-T cells infusion
Leukemia-free survival (LFS)
Time frame: Up to 2 years after CD19 CAR-T cells infusion
Overall survival (OS)
Time frame: Up to 2 years after CD19 CAR-T cells infusion
cumulative incidence of relapse (CIR)
Time frame: Up to 2 years after CD19 CAR-T cells infusion
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Through study completion, an average of 2 years
Characterization of relapse
Time frame: Through study completion, an average of 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Derived from this study: PubMed 40244598Zhang M, Fu S, Feng J, Hong R, Wei G, Zhao H, Zhao M, Xu H, Cui J, Huang S, Wu X, Liu L, Sun J, Wu W, Zhu Y, He J, Zhao Y, Cai Z, Zheng W, Ye X, Shi J, Luo Y, Wang D, Chang AH, Hu Y, Huang H. Dasatinib and CAR T-Cell Therapy in Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia: A Nonrandomized Clinical Trial. JAMA Oncol. 2025 Jun 1;11(6):625-629. doi: 10.1001/jamaoncol.2025.0674.
- Individual participant dataSharing planned: No
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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 Phase 2 study testing CAR-T cells targeting CD19 and CD22 in people with B-Cell Acute Lymphoblastic Leukemia, Adult, run by Zhejiang 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 11 inclusion and 12 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: finished, as of the sponsor's last update on 17 Oct 2024. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Complete molecular response (CMR) rate (time frame: Up to 1 month after CAR-T cells infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04788472, which also lists 1 linked publication.
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 Oct 2024.