ALLPhase 2NCT07252336
A Multicenter Study of CAR-T Cells in Primary Ph+All
A Phase 2 study testing CD19 CAR-T cells in people with ALL, run by Zhejiang University at 1 site in China.
Trial summary
A Multicenter Study of CD19 CAR-T Cells in the Treatment of Adult Patients With Primary Ph Chromosome Positive Acute Lymphoblastic Leukemia Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ALL
- What is being tested?
- CD19 CAR-T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2025to 30 Nov 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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, gender not restricted;
- Subjects diagnosed with B-cell acute lymphoblastic leukemia (B-ALL) in accordance with the 2016 WHO Classification of Acute Leukemias;
- Abnormal B cells positive for CD19 and CD22 by immunophenotyping;
- Subjects positive for Philadelphia chromosome (Ph chromosome) and BCR/ABL1 fusion gene by chromosomal and corresponding genetic testing;
- Newly diagnosed B-ALL patients who have not received treatment with standard chemotherapy regimens;
- Serum total bilirubin ≤ 51 μmol/L, serum ALT and AST both ≤ 3 times the upper limit of the normal reference range, and serum creatinine ≤ 176.8 μmol/L;
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- Left ventricular ejection fraction (LVEF) ≥ 50% as assessed by echocardiography;
- Subjects with no active pulmonary infection and oxygen saturation ≥ 92% without oxygen supplementation;
- Estimated survival time ≥ 3 months;
- ECOG performance status score 0-2;
- Females and males of childbearing potential must agree to use appropriate contraceptive measures before enrollment, during study participation, and within 6 months after infusion;
- Subjects voluntarily participate in this study and sign the informed consent form.
Who cannot join
- Subjects meeting any of the following exclusion criteria are ineligible for enrollment in this study:
- Subjects with a history of epilepsy or other central nervous system diseases;
- Subjects with a prior history of QT interval prolongation or severe cardiac diseases;
- Pregnant or lactating women (the safety of this therapy for unborn children is unknown);
- Subjects with untreated active infections;
- Subjects with serological evidence of chronic hepatitis B virus (HBV) infection who are unable or unwilling to receive standard prophylactic antiviral treatment, or have a detectable HBV viral DNA load; subjects with serological evidence of hepatitis C virus (HCV) infection who have not completed curative treatment or have a detectable HCV viral load;
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- Human immunodeficiency virus (HIV) antibody positive;
- Syphilis antibody positive;
- Subjects who have previously received any gene therapy products;
- Subjects with other uncontrolled diseases who, in the investigator's judgment, are unsuitable for enrollment;
- Any other conditions that, in the investigator's judgment, may increase the risk to the subject or interfere with the study results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, 310003
He Huang, MD, 13605714822, hehuangyu@126.com
Yongxian Hu, 057187233772, huyongxian2000@aliyun.com
About this study
Official title: A Multicenter Study of CD19 CAR-T Cells in the Treatment of Adult Patients With Primary Ph Chromosome Positive Acute Lymphoblastic Leukemia
A Multicenter Study of CD19 CAR-T Cells in the Treatment of Adult Patients With Primary Ph Chromosome Positive Acute Lymphoblastic Leukemia
Read the detailed description
This study is a single-arm, open-label, multicenter clinical trial that plans to enroll approximately 50 adult patients with newly diagnosed Ph-positive acute lymphoblastic leukemia to undergo CD19 CAR-T cell therapy. The primary objective is to evaluate the efficacy of CD19 CAR-T therapy in adult patients with newly diagnosed Ph-positive acute lymphoblastic leukemia. The secondary objective is to assess the safety of CD19 CAR-T therapy in this patient population. The exploratory objectives include evaluating the in vivo expansion and persistence of CAR-T cells, as well as B-cell depletion.
- Conditions
- ALL
- Being tested
- CD19 CAR-T cells
- Keywords
- CD19 CAR-T
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD19 CAR-T cellsDrug
Each subject receive CD19/CD22 CAR T-cells by intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| CAR-T cells（ chimeric antigen receptor T cells） | Experimental | CD19 CAR-T 2×10e6 CAR+ T cells/kg, Receives: Drug: CD19 CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Molecular Response Rate after CD19 CAR-T Cell Therapy
Laboratory tests
Measured: 28 days after infusion
Secondary outcomes (4)
Leukemia-Free Survival
Survival follow-up
Measured: 2 years after infusion
Overall survival
Survival follow-up
Measured: 2 years after infusion
Cumulative Incidence of Relapse
Laboratory tests
Measured: 2 years after infusion
Complete Molecular Response Rate after CD22 CAR-T Cell Therapy
Laboratory tests
Measured: 2 years after infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start30 Nov 2025 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALLStudies 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
- 50 participants (estimated)
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
- NCT07252336
- Sponsor's protocol ID
- TXB2025020
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 4 Dec 2025
- 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 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study of CD19 CAR-T Cells in the Treatment of Adult Patients With Primary Ph Chromosome Positive Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT07252336
- Acronym / sponsor ID
- TXB2025020
- Conditions
- ALL
- Keywords
- CD19 CAR-T
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Yake Biotechnology Ltd.
- Study start
- 30 Nov 2025 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 26 Nov 2025 (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.
A Multicenter Study of CD19 CAR-T Cells in the Treatment of Adult Patients With Primary Ph Chromosome Positive Acute Lymphoblastic Leukemia
Detailed description
This study is a single-arm, open-label, multicenter clinical trial that plans to enroll approximately 50 adult patients with newly diagnosed Ph-positive acute lymphoblastic leukemia to undergo CD19 CAR-T cell therapy. The primary objective is to evaluate the efficacy of CD19 CAR-T therapy in adult patients with newly diagnosed Ph-positive acute lymphoblastic leukemia. The secondary objective is to assess the safety of CD19 CAR-T therapy in this patient population. The exploratory objectives include evaluating the in vivo expansion and persistence of CAR-T cells, as well as B-cell depletion.
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 cells（ chimeric antigen receptor T cells） | Experimental | Drug: CD19 CAR-T cellsCD19 CAR-T 2×10e6 CAR+ T cells/kg, |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥ 18 years old, gender not restricted;
- Subjects diagnosed with B-cell acute lymphoblastic leukemia (B-ALL) in accordance with the 2016 WHO Classification of Acute Leukemias;
- Abnormal B cells positive for CD19 and CD22 by immunophenotyping;
- Subjects positive for Philadelphia chromosome (Ph chromosome) and BCR/ABL1 fusion gene by chromosomal and corresponding genetic testing;
- Newly diagnosed B-ALL patients who have not received treatment with standard chemotherapy regimens;
Key exclusion criteria (11 listed)
- Subjects meeting any of the following exclusion criteria are ineligible for enrollment 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 |
|---|---|---|
| CD19 CAR-T cellsEach subject receive CD19/CD22 CAR T-cells by intravenous infusion | Drug | CAR-T cells（ chimeric antigen receptor T cells） |
Primary outcome
Complete Molecular Response Rate after CD19 CAR-T Cell Therapy
Time frame: 28 days after infusion
Laboratory tests
4 secondary outcomes
Leukemia-Free Survival
Time frame: 2 years after infusion
Overall survival
Time frame: 2 years after infusion
Cumulative Incidence of Relapse
Time frame: 2 years after infusion
Complete Molecular Response Rate after CD22 CAR-T Cell Therapy
Time frame: 2 years after infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
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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.
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 CD19 CAR-T cells in people with ALL, 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 12 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 4 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact He Huang, MD (13605714822, hehuangyu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Molecular Response Rate after CD19 CAR-T Cell Therapy (time frame: 28 days after infusion). 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 4 Dec 2025; AzTrials last refreshed its copy on 26 Oct 2026.