Double strike: engineered immune cells and targeted pill take on tough leukemia
NCT ID NCT07074496
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new approach for people newly diagnosed with a specific, aggressive leukemia (Ph+ ALL). It combines a single infusion of specially engineered immune cells (CAR-T cells) with a daily targeted pill (olverembatinib). The goal is to see if this powerful one-two punch can safely wipe out the cancer at the genetic level. The trial involves 20 adults and will closely monitor for side effects and how well the cancer responds.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ThisCART19A (a type of CAR-T cell therapy) and olverembatinib (a targeted cancer drug)
- What this could lead to
- If successful, this combination could offer a powerful upfront treatment for a hard-to-treat leukemia, potentially leading to deep and lasting remission without the need for long-term chemotherapy.
- What could go wrong
- This is a very early (Phase 1) and small study with only 20 people. The treatment carries risks of serious side effects, including cytokine release syndrome and nervous system problems. It may not work for everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2024
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or non-pregnant, non-lactating female patients who are 18 years of age or older. 2. 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. 3. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2, and expected survival period ≥ 3 months. 4. 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%; Exclusion Criteria: 1. 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.) ; 2. Uncontrolled active infection; 3. Patients who are currently suffering from active autoimmune disease or a history of autoimmune disease potentially involving the CNS; 4. Patients who have any history of heart or vascular disease, such as hypertension (systolic blood pressure(HBP) \> 140mmHg and/or diastolic blood pressure \> 90mmHg); 5. Cardiac ultrasonography indicates that pulmonary artery systolic blood pressure is \>50 mmHg; or there are clinical symptoms related to pulmonary arterial hypertension; 6. Patients who suffer from severe bleeding disorders unrelated to Ph+ ALL; 7. Patients who have any other malignant tumors that require treatment; 8. Patients who have severe hypertriglyceridemia (triglyceride ≥ 5.6mmol/L); 9. Patients who are pregnant, planning to become pregnant or breastfeeding; 10. Patients who underwent major surgery (except for minor surgery such as catheter placement or bone marrow biopsy) within 14 days before the first drug; 11. 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; 12. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
RECRUITINGSuzhou, Jiangsu, 215000, China
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The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
RECRUITINGSuzhou, Jiangsu, 215006, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New drug cocktail aims to improve remission in older leukemia patients
- Real-World watch on ph+ leukemia treatments aims to uncover best paths to remission
- New drug aims to keep leukemia in remission after transplant
- Could natural immune cells help fight leukemia drug resistance?
- Real-World data suggests asciminib may help some leukemia patients
- New hope for tough leukemias? trial of vodobatinib begins, then stops