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Triple threat: targeted drugs + CAR-T cells aim to beat a tough leukemia
NCT ID NCT06481228
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This clinical trial is testing a new treatment approach for adults newly diagnosed with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). The treatment combines targeted drugs (olverembatinib and venetoclax) with reduced-intensity chemotherapy, followed by CAR-T cell therapy. The goal is to achieve deeper remission, reduce the need for multiple chemotherapy cycles, and improve survival and quality of life. The study will enroll 82 participants and track outcomes like disease-free survival and side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CAR-T cells, venetoclax, and olverembatinib
- What this could lead to
- If successful, this approach could offer a more effective and less toxic first-line treatment for Philadelphia chromosome-positive acute lymphoblastic leukemia, potentially improving long-term survival and quality of life.
- What could go wrong
- This is an early-phase study with a small number of participants (82). The combination therapy may cause unexpected side effects, and the long-term benefits are not yet proven. CAR-T cell therapy carries risks like cytokine release syndrome.
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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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 82 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2024
- Expected to finish
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Jun 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 female patients aged 18 years or older 2. Newly diagnosed Philadelphia chromosome positive(either t(9;22) and/or BCR-ABL positive and/ or FISH positive) acute lymphoblastic leukemia 3. CD19 expression on blasts 4. Expected survival time greater than 3 months 5. Adequate end organ function as defined by: Total bilirubin ≤ 1.5 x upper limit of normal(ULN); serum alanine aminotransferase (ALT) and serum aspartate aminotransferase (AST) ≤ 2.5 x ULN or ≤5 x ULN if leukemic involvement of the liver is present; Creatinine ≤ 1.5 x ULN; Serum amylase and lipase ≤ 1.5 x ULN; Alkaline phosphatase ≤ 2.5 x ULN unless considered tumor related; normal electrolytes: Potassium ≥ LLN; Magnesium ≥ LLN; Phosphorus ≥ LLN; Cardiac color Doppler ultrasound ejection fraction ≥ 45% 6. Subject has provided written informed consent prior to any screening procedure Exclusion Criteria: 1. Lymphoid blast crisis of chronic myelocytic leukemia (CML) 2. Previous or ongoing systemic anti-ALL therapy (including but not restricted to TKI and/or radiotherapy, except for appropriate pre-treatment) 3. Patients with a history of myocardial infarction within 12 months or clinically significant cardiac disorders disease (e.g., unstable angina, congestive heart failure, uncontrollable hypertension, uncontrollable arrhythmia, etc.) 4. Uncontrolled active serious infections that could, in the investigator's opinion, potentially interfere with the completion of treatment 5. Known HIV seropositivity 6. History of acute pancreatitis within 1 year of study screening or history of chronic pancreatitis 7. Uncontrolled hypertriglyceridemia (triglycerides \>450 mg/dL) 8. Another malignancy diagnosed and treated within 5 years prior to diagnosis or previously diagnosed with another malignancy with evidence of residual disease. Patients with non-melanoma skin cancer or any type of carcinoma in situ that has been completely excised should not be excluded 9. Female patients who are pregnant or breast feeding 10. Clinical manifestations of active CNS or extramedullary involvement with ALL 11. Poorly controlled diabetes, defined as glycosylated hemoglobin (HbA1c) values of \>7.5%. Patients with preexisting, well-controlled diabetes are not excluded 12. Any serious psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment 13. Other conditions assessed by the investigators to be inappropriate for this study
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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
1 site. 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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Institute of Hematology & Blood Diseases Hospital
RECRUITINGTianjin, 300020, China
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