B Acute Lymphoblastic LeukemiaPhase 2NCT06078306
CD19CD22 CAR-T Therapy in Patients With High-Risk B Acute Lymphoblastic Leukemia (B-ALL).
A Phase 2 study testing Azacitidine Injection, Venetoclax and CD19CD22 CAR-T in people with B Acute Lymphoblastic Leukemia and Ph-Negative ALL, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
Clinical trial for the safety and efficacy of induction chemotherapy with VA regime and bridging CD19CD22 CAR-T therapy in adult patients with newly diagnosed high-risk and Ph- B-ALL Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- B Acute Lymphoblastic Leukemia, Ph-Negative ALL, High Risk Acute Lymphoblastic Leukemia
- What is being tested?
- Azacitidine Injection, Venetoclax and CD19CD22 CAR-T
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2024to 10 Sep 2025
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age≥18 and ≤65 years old
- Newly diagnosed and high risk B-ALL according to the 2022 WHO classification
- The immunophenotype of leukemia cells were CD19 and CD22 positive and Ph-;
- Anticipated survival time more than 12 weeks;
- Those who voluntarily participated in this trial and provided informed consent.
Who cannot join
- History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;
- Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
- Pregnant (or lactating) women;
- Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
- Human immunodeficiency virus (HIV) positive; Active infection of hepatitis B virus or hepatitis C virus
- Previously treated with any CAR-T cell product or other genetically-modified T cell therapies;
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- Creatinine>2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin>2.0 mg/dl;
- Other uncontrolled diseases that were not suitable for this trial;
- Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xiaowen Tang
Suzhou, Jiangsu, 215000
xiaowen Tang, phD, 86-512-67781525, xwtang1020@163.com
Depei Wu, PhD, 86-512-67781856, wudepei@163.com
About this study
Official title: Clinical Trial for the Safety and Efficacy of Induction Chemotherapy With Azacitidine+Venetoclax (VA) and Bridging CD19CD22 CAR-T Therapy in Adult Patients With Newly Diagnosed High-Risk and Ph-negative (Ph-) B-ALL
Clinical trial for the safety and efficacy of induction chemotherapy with VA regime and bridging CD19CD22 CAR-T therapy in adult patients with newly diagnosed high-risk and Ph- B-ALL
Read the detailed description
To evaluate the safety and efficacy of induction chemotherapy with VA regime and bridging CD19CD22 CAR-T therapy in Adult patients with newly diagnosed high-risk and Ph- B-ALL in this prospective, single arm study.
- Being tested
- Azacitidine Injection, Venetoclax, CD19CD22 CAR-T
- Medical subject headings
- Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azacitidine InjectionDrug
Also called Azacitidine
Azacitidine Injection 75mg/square meter/day, day1-7, subcutaneous injection
VenetoclaxDrug
Also called ABT-199
Venetoclax 100mg day 1, 200mg day 2, 400mg d3-d21, oral
CD19CD22 CAR-TDrug
Also called GDC-0199
After induction chemotherapy with Azacitidine+Venetoclax, each subject receives CD19CD22 CAR-T cells by intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| CAR-T therapy | Experimental | Therapeutic outcomes in adults with Ph- B-ALL have substantially improved in the last decade, with complete remission (CR) and long-term overall survival (OS) rates of around 90% and 40%-50%, respectively. The presence of measurable residual disease (MRD) is the strongest predictor of relapse in B-ALL. In this study, high risk Ph- B-ALL patients receive the induction chemotherapy with Azacitidine+Venetoclax. After induction chemotherapy with Azacitidine+Venetoclax (VA regime), each subject receives CD19CD22 CAR-T cells by intravenous infusion. The patients with MRD negative will undergo HSCT. Receives: Drug: Azacitidine Injection; Drug: Venetoclax; Drug: CD19CD22 CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Remission Rate
MRD Negative Remission Rate after CD19CD22 cell therapy
Measured: The cycle of CD19CD22 cell therapy is day 2-4; Effect evaluation was day 21 after CD19CD22 cells infusion
Secondary outcomes (4)
Complete Remission Rate of VA regime
Complete Remission Rate after VA regime
Measured: The cycle of VA regime is day 21; Effect evaluation was day 7 after VA regime
Complete Molecular Remission Rate
Complete Molecular Remission Rate after CD19CD22 CAR-T cell therapy
Measured: The cycle of CD19CD22 cell therapy is day 2-4; Effect evaluation was day 21 after CD19CD22 cells infusion
Overall survival (OS)
From the first infusion of CD19CD22 cells to death or the last visit
Measured: The cycle of CD19CD22 cell therapy is day 2-4; Effect evaluation was 2 years after CD19CD22 CAR-T cells infusion
Leukemia-free survival (LFS)
Up to 2 years after CD19CD22 CAR-T cells infusion
Measured: The cycle of CD19CD22 cell therapy is day 2-4; Effect evaluation was 2 years after CD19CD22 CAR-T cells infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start20 Apr 2024 (estimated)
- Primary completion10 Sep 2024 (estimated)
- Study completion10 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06078306
- Sponsor's protocol ID
- High Risk B-ALL
- Status last verified
- Oct 2023
- First submitted
- 11 Sep 2023
- Last updated
- 22 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial for the Safety and Efficacy of Induction Chemotherapy With Azacitidine+Venetoclax (VA) and Bridging CD19CD22 CAR-T Therapy in Adult Patients With Newly Diagnosed High-Risk and Ph-negative (Ph-) B-ALL
- ClinicalTrials.gov ID
- NCT06078306
- Acronym / sponsor ID
- High Risk B-ALL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 20 Apr 2024 (estimated)
- Primary completion
- 10 Sep 2024 (estimated)
- Study completion
- 10 Sep 2025 (estimated)
- First posted
- 11 Oct 2023 (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 safety and efficacy of induction chemotherapy with VA regime and bridging CD19CD22 CAR-T therapy in adult patients with newly diagnosed high-risk and Ph- B-ALL
Detailed description
To evaluate the safety and efficacy of induction chemotherapy with VA regime and bridging CD19CD22 CAR-T therapy in Adult patients with newly diagnosed high-risk and Ph- B-ALL in this prospective, single arm study.
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: Azacitidine Injection, Drug: Venetoclax, Drug: CD19CD22 CAR-TTherapeutic outcomes in adults with Ph- B-ALL have substantially improved in the last decade, with complete remission (CR) and long-term overall survival (OS) rates of around 90% and 40%-50%, respectively. The presence of measurable residual disease (MRD) is the strongest predictor of relapse in B-ALL. In this study, high risk Ph- B-ALL patients receive the induction chemotherapy with Azacitidine+Venetoclax. After induction chemotherapy with Azacitidine+Venetoclax (VA regime), each subject receives CD19CD22 CAR-T cells by intravenous infusion. The patients with MRD negative will undergo HSCT. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age≥18 and ≤65 years old
- Newly diagnosed and high risk B-ALL according to the 2022 WHO classification
- The immunophenotype of leukemia cells were CD19 and CD22 positive and Ph-;
- Anticipated survival time more than 12 weeks;
- Those who voluntarily participated in this trial and provided informed consent.
Key exclusion criteria (9 listed)
- History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;
- Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
- Pregnant (or lactating) women;
- Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
- Human immunodeficiency virus (HIV) positive; Active infection of hepatitis B virus or hepatitis C virus
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 |
|---|---|---|
| Azacitidine InjectionAlso: AzacitidineAzacitidine Injection 75mg/square meter/day, day1-7, subcutaneous injection | Drug | CAR-T therapy |
| VenetoclaxAlso: ABT-199Venetoclax 100mg day 1, 200mg day 2, 400mg d3-d21, oral | Drug | CAR-T therapy |
| CD19CD22 CAR-TAlso: GDC-0199After induction chemotherapy with Azacitidine+Venetoclax, each subject receives CD19CD22 CAR-T cells by intravenous infusion | Drug | CAR-T therapy |
Primary outcome
Complete Remission Rate
Time frame: The cycle of CD19CD22 cell therapy is day 2-4; Effect evaluation was day 21 after CD19CD22 cells infusion
MRD Negative Remission Rate after CD19CD22 cell therapy
4 secondary outcomes
Complete Remission Rate of VA regime
Time frame: The cycle of VA regime is day 21; Effect evaluation was day 7 after VA regime
Complete Molecular Remission Rate
Time frame: The cycle of CD19CD22 cell therapy is day 2-4; Effect evaluation was day 21 after CD19CD22 cells infusion
Overall survival (OS)
Time frame: The cycle of CD19CD22 cell therapy is day 2-4; Effect evaluation was 2 years after CD19CD22 CAR-T cells infusion
Leukemia-free survival (LFS)
Time frame: The cycle of CD19CD22 cell therapy is day 2-4; Effect evaluation was 2 years after CD19CD22 CAR-T cells infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- 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.
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 Azacitidine Injection, Venetoclax and CD19CD22 CAR-T in people with B Acute Lymphoblastic Leukemia and Ph-Negative ALL, run by The First Affiliated Hospital of Soochow 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 5 inclusion and 9 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 22 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Remission Rate (time frame: The cycle of CD19CD22 cell therapy is day 2-4; Effect evaluation was day 21 after CD19CD22 cells 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 22 Apr 2024; AzTrials last refreshed its copy on 6 Nov 2026.