Philadelphia Chromosome-Positive Acute Lymphoblastic LeukemiaEarly Phase 1NCT07074496
Efficacy, Safety, and Pharmacokinetics of ThisCART19A Combined With Olverembatinib in Patients With Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia.
A Early Phase 1 study testing ThisCART19A, Fludarabine and Cyclophosphamide in people with Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia, run by The First Affiliated Hospital of Soochow University at 2 sites in China.
Trial summary
This is an Open, Prospective, Single-arm Study, which is designed to evaluate the efficacy, safety and pharmacokinetics of ThisCART19A Combined With Olverembatinib for the treatment of Newly Diagnosed Ph-positive lymphoblastic leukemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
- What is being tested?
- ThisCART19A, Fludarabine and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jan 2024to 1 Jul 2028
- Phase
- Early Phase 1
- 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
- Male or non-pregnant, non-lactating female patients who are 18 years of age or older.
- Newly diagnosed Philadelphia chromosome-positive (Ph+) or BCR-ABL1-positive ALL, as defined by the 2016-WHO criteria. Participants should not be treated with any kind of TKIs or chemotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2, and expected survival period ≥ 3 months.
- Organ function as indicated by the following laboratory indicators must be met:
- 1. Alanine aminotransferase (ALT) ≤ 5×upper limit of normal (ULN), aspartate aminotransferase (AST) ≤ 5×ULN; 2. Total bilirubin<2×ULN; 3. 24-hour calculated creatinine clearance>30 mL/min; 4. SpO2≥92%; 5. Cardiac ejection fraction (EF)≥40%;
Who cannot join
- Active hepatitis B virus (defined as serum HBV-DNA ≥ 2000 IU/mL), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or active syphilis infection prior to enrollment. (Subjects with HBV-DNA < 2000 IU/mL can be enrolled, but should be administered antiviral drugs such as entecavir and tenofovir with relative clinical indicators monitored simultaneously during the treatment.) ;
- Uncontrolled active infection;
- Patients who are currently suffering from active autoimmune disease or a history of autoimmune disease potentially involving the CNS;
- Patients who have any history of heart or vascular disease, such as hypertension (systolic blood pressure(HBP) > 140mmHg and/or diastolic blood pressure > 90mmHg);
- Cardiac ultrasonography indicates that pulmonary artery systolic blood pressure is >50 mmHg; or there are clinical symptoms related to pulmonary arterial hypertension;
- Patients who suffer from severe bleeding disorders unrelated to Ph+ ALL;
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- Patients who have any other malignant tumors that require treatment;
- Patients who have severe hypertriglyceridemia (triglyceride ≥ 5.6mmol/L);
- Patients who are pregnant, planning to become pregnant or breastfeeding;
- Patients who underwent major surgery (except for minor surgery such as catheter placement or bone marrow biopsy) within 14 days before the first drug;
- Patients who may not be able to complete all study visits or procedures required by the study protocol, including follow-up visits, and/or fail to comply with all required study procedures;
- Patients who suffer from any condition or illness that, in the opinion of the Investigator, would compromise patient safety or interfere with the evaluation of the safety of the research drug.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
Suzhou, Jiangsu, 215000
Suning Chen, +86.13814881746, chensuning@sina.com
- Recruiting
The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
Suzhou, Jiangsu, 215006
Suning Chen, 13814881746, windy020051229@126.com
About this study
Official title: An Open, Prospective, Single-arm Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Allogeneic Anti CD19 CAR-T Combined With a Novel Third-generation TKI Olverembatinib in Patients With Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia.
This is an Open, Prospective, Single-arm Study, which is designed to evaluate the efficacy, safety and pharmacokinetics of ThisCART19A Combined With Olverembatinib for the treatment of Newly Diagnosed Ph-positive lymphoblastic leukemia.
Read the detailed description
To evaluate the efficacy, safety and pharmacokinetics of ThisCART19A Combined With Olverembatinib for the treatment of Ph-positive lymphoblastic leukemia. Newly diagnosed Ph-positive patients will be given VP chemotherapy for induction treatment until the leukocyte count is less than 10×109/L. Then chemotherapy regimen of fludarabine and cyclophosphamide followed by a infusion of ThisCART19A. These patients will combination with Olverembatinib as maintenance therapy based on the hematologic complete remission of leukemia after 4 weeks of treatment.
Patients could receive an additional infusion of ThisCART19A if they achieved initial benefit and subsequently minimal residual disease positive (defined as Flow-cytometric MRD≥0.1%) during maintenance treatment. Additionally, a subset of patients which achieved complete molecular remission over 6 month were eligible for a second planned infusion as a consolidation therapy .
During the treatment, lumbar puncture combined with sheath injection will be performed to prevent central nervous system leukemia (CSNL). If CNSL occurs at the time of admission, patients should receive regular conventional lumbar puncture and sheath injection for treating CNSL.
During the treatment, each subject will be evaluated regularly, including hematological response, FCM-MRD, cytogenetic response and molecular remission rate, as well as adverse events. EFS and OS will be followed up for 2 years.
- Being tested
- ThisCART19A, Fludarabine, Cyclophosphamide, Olverembatinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThisCART19ADrug
ThisCART19A is a new type CAR-T therapy for patients with ph+ ALL.
FludarabineDrug
Fludarabine is used for lymphodepletion.
CyclophosphamideDrug
Cyclophosphamide is used for lymphodepletion.
OlverembatinibDrug
a third-generation TKI
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | ThisCART19A cells infusion, Given intravenously，Combined With Olverembatinib, Given PO Receives: Drug: ThisCART19A; Drug: Fludarabine; Drug: Cyclophosphamide; Drug: Olverembatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Complete Molecular Remission
Will be estimated along with the 95% credible intervals. Complete molecular response (CMR) was defined as the absence of a detectable BCR-ABL1 transcript with a sensitivity of 0.01%.
Measured: 3 months
Incidence of adverse events (AEs)
Will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. The proportion of patients with AEs will be estimated, along with the Bayesian 95% credible interval.
Measured: 2 years
Secondary outcomes (4)
Objective Response Rate (ORR)
Will be estimated along with the 95% credible intervals. ORR is defined by Complete Remission (CR)+ CR with incomplete marrow recovery (CRi) .
Measured: 2 years
Duration of Complete Molecular Remission
Will be estimated along with the 95% credible intervals.
Measured: From the date of acquisition of complete molecular remission until the date of loss of complete molecular remission, assessed up to 2 years.
Event-free survival (EFS)
The Kaplan-Meier method will be used to assess EFS probabilities.
Measured: From the first day of treatment until any failure (resistant disease, relapse, or death), assessed up to 2 years
Overall survival (OS)
The Kaplan-Meier method will be used to assess OS probabilities.
Measured: From the first day of treatment to time of death from any cause, assessed up 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start1 Jan 2024
- Primary completion15 Nov 2025
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Philadelphia Chromosome-Positive 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
- Early Phase 1
- 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
- Collaborators
- Fundamenta Therapeutics, Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07074496
- Sponsor's protocol ID
- ThisCART19A Ph+ALL
- Status last verified
- Jul 2025
- First submitted
- 6 Jan 2024
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Prospective, Single-arm Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Allogeneic Anti CD19 CAR-T Combined With a Novel Third-generation TKI Olverembatinib in Patients With Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia.
- ClinicalTrials.gov ID
- NCT07074496
- Acronym / sponsor ID
- ThisCART19A Ph+ALL
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Collaborators
- Fundamenta Therapeutics, Ltd.
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 15 Nov 2025 (actual)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 20 Jul 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.
This is an Open, Prospective, Single-arm Study, which is designed to evaluate the efficacy, safety and pharmacokinetics of ThisCART19A Combined With Olverembatinib for the treatment of Newly Diagnosed Ph-positive lymphoblastic leukemia.
Detailed description
To evaluate the efficacy, safety and pharmacokinetics of ThisCART19A Combined With Olverembatinib for the treatment of Ph-positive lymphoblastic leukemia. Newly diagnosed Ph-positive patients will be given VP chemotherapy for induction treatment until the leukocyte count is less than 10×109/L. Then chemotherapy regimen of fludarabine and cyclophosphamide followed by a infusion of ThisCART19A. These patients will combination with Olverembatinib as maintenance therapy based on the hematologic complete remission of leukemia after 4 weeks of treatment.
Patients could receive an additional infusion of ThisCART19A if they achieved initial benefit and subsequently minimal residual disease positive (defined as Flow-cytometric MRD≥0.1%) during maintenance treatment. Additionally, a subset of patients which achieved complete molecular remission over 6 month were eligible for a second planned infusion as a consolidation therapy .
During the treatment, lumbar puncture combined with sheath injection will be performed to prevent central nervous system leukemia (CSNL). If CNSL occurs at the time of admission, patients should receive regular conventional lumbar puncture and sheath injection for treating CNSL.
During the treatment, each subject will be evaluated regularly, including hematological response, FCM-MRD, cytogenetic response and molecular remission rate, as well as adverse events. EFS and OS will be followed up for 2 years.
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 | Drug: ThisCART19A, Drug: Fludarabine, Drug: Cyclophosphamide, Drug: OlverembatinibThisCART19A cells infusion, Given intravenously，Combined With Olverembatinib, Given PO |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or non-pregnant, non-lactating female patients who are 18 years of age or older.
- Newly diagnosed Philadelphia chromosome-positive (Ph+) or BCR-ABL1-positive ALL, as defined by the 2016-WHO criteria. Participants should not be treated with any kind of TKIs or chemotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2, and expected survival period ≥ 3 months.
- Organ function as indicated by the following laboratory indicators must be met:
- 1. Alanine aminotransferase (ALT) ≤ 5×upper limit of normal (ULN), aspartate aminotransferase (AST) ≤ 5×ULN; 2. Total bilirubin<2×ULN; 3. 24-hour calculated creatinine clearance>30 mL/min; 4. SpO2≥92%; 5. Cardiac ejection fraction (EF)≥40%;
Key exclusion criteria (12 listed)
- Active hepatitis B virus (defined as serum HBV-DNA ≥ 2000 IU/mL), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or active syphilis infection prior to enrollment. (Subjects with HBV-DNA < 2000 IU/mL can be enrolled, but should be administered antiviral drugs such as entecavir and tenofovir with relative clinical indicators monitored simultaneously during the treatment.) ;
- Uncontrolled active infection;
- Patients who are currently suffering from active autoimmune disease or a history of autoimmune disease potentially involving the CNS;
- Patients who have any history of heart or vascular disease, such as hypertension (systolic blood pressure(HBP) > 140mmHg and/or diastolic blood pressure > 90mmHg);
- Cardiac ultrasonography indicates that pulmonary artery systolic blood pressure is >50 mmHg; or there are clinical symptoms related to pulmonary arterial hypertension;
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 |
|---|---|---|
| ThisCART19AThisCART19A is a new type CAR-T therapy for patients with ph+ ALL. | Drug | Treatment Group |
| FludarabineFludarabine is used for lymphodepletion. | Drug | Treatment Group |
| CyclophosphamideCyclophosphamide is used for lymphodepletion. | Drug | Treatment Group |
| Olverembatiniba third-generation TKI | Drug | Treatment Group |
Primary outcome
Number of Participants with Complete Molecular Remission
Time frame: 3 months
Will be estimated along with the 95% credible intervals. Complete molecular response (CMR) was defined as the absence of a detectable BCR-ABL1 transcript with a sensitivity of 0.01%.
Incidence of adverse events (AEs)
Time frame: 2 years
Will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. The proportion of patients with AEs will be estimated, along with the Bayesian 95% credible interval.
4 secondary outcomes
Objective Response Rate (ORR)
Time frame: 2 years
Duration of Complete Molecular Remission
Time frame: From the date of acquisition of complete molecular remission until the date of loss of complete molecular remission, assessed up to 2 years.
Event-free survival (EFS)
Time frame: From the first day of treatment until any failure (resistant disease, relapse, or death), assessed up to 2 years
Overall survival (OS)
Time frame: From the first day of treatment to time of death from any cause, assessed up 2 years
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 17 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing ThisCART19A, Fludarabine and Cyclophosphamide in people with Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia, run by The First Affiliated Hospital of Soochow University at 2 sites 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 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: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Suning Chen, professor (+86-13814881746, chensuning@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Complete Molecular Remission (time frame: 3 months). The study lists 2 primary outcomes in all. 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 17 Jun 2026.