Engineered immune cells show promise against hard-to-treat leukemia
NCT ID NCT03984968
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new treatment for adults with a specific type of leukemia (Philadelphia chromosome-positive B-ALL). The treatment uses a patient's own immune cells that are modified in a lab to find and attack cancer cells. The goal is to see if this approach is safe and can help keep the cancer from coming back after initial treatment. About 40 people will take part.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2017
- Expected to finish
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Jul 2040
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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15 to 65 years
- 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: * 15-65 years of age at the time of signing informed consent * Diagnosed as de novo Philadelphia chromosome-positive CD19+ B-ALL * Karnofsky performance status ≥ 60 or Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 * Unable to find a suitable donor or for other reasons to undergo allogeneic hematopoietic stem cell transplantation during the study * Ability and willingness to adhere to the study visit schedule and all protocol requirements * Voluntarily sign informed consent forms Exclusion Criteria: * Unable to tolerate any kind of TKIs (including the first- and second-generation tyrosine kinase inhibitors) for a long period. * Subjects who have positive mutation(s) of the ABL kinase domain and require the third-generation tyrosine kinase inhibitors for long-term therapies. * Inadequate hepatic function defined by aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 3 × upper limit of normal (ULN) and direct bilirubin \> 1.5 × ULN * Inadequate renal function defined by serum creatinine \> 1.6 mg/dL * International ratio (INR) or partial thromboplastin time (PTT) \> 1.5 x ULN * Left ventricular ejection fraction \< 50% * Ongoing treatment with chronic immunosuppressants * Significant comorbid conditions or diseases which, in the judgment of the investigator, would place the subject at undue risk or interfere with the study; examples include, but are not limited to, cirrhotic liver disease, sepsis, recent significant traumatic injury, and other conditions * Known human immunodeficiency virus (HIV) positivity * Subjects with a history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control * Subjects with second malignancies in addition to ALL * Pregnant or lactating women, or subjects refusing to take effective contraception measures * Other contraindications that are considered inappropriate to participate in this trial
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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.
Contacts and locations
Locations
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The First Affliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China