Engineered t cells take aim at Hard-to-Treat leukemia
NCT ID NCT01044069
First seen Jun 27, 2026 · Last updated Sep 09, 2026 · Updated 2 times
Summary
This early-stage study tests a new approach for adults with B-cell acute lymphoblastic leukemia (B-ALL) that has returned or not responded to standard treatment. Researchers take a patient's own T cells, modify them in the lab to recognize and attack leukemia cells, and infuse them back after chemotherapy. The main goal is to check safety and find the right dose, while also seeing if the treatment can reduce or control the leukemia.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 93 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2010
- Expected to finish
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Jan 2027
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: * Adult patients are eligible (\> or = to 18 year old). * Patients must have B- ALL refractory, relapsed, MRD, or in first CR as described below. * Complete remission is defined as restoration of normal hematopoiesis with a neutrophil count \> 1,000 x 106/L, a platelet count \> 100,000 x 106/L, and hemoglobin \> 10 g/dL. Blasts should be \< 5% in a post-treatment bone marrow differential. Furthermore, there should be no clinical evidence of leukemia for a minimum of four weeks. * MRD is defined as patients meeting the criteria for CR above, but with residual disease measured by a quantitative PCR, or by flow or by deep-sequencing of the IgH rearrangements . The assay from blood and/or bone marrow defines MRD by qPCR as a cycle threshold (CT) that is at least 1 CT value \< than the lowest CT value from the background. Outside laboratory tests may suffice for this assessment at the discretion of the Principal Investigator. Relapsed B-ALL will be defined as patients that meet the above criteria for a CR before developing recurrent disease (increased bone marrow blasts). Refractory patients will be defined as patients that have not achieved a CR after 1 cycle of induction chemotherapy * Patients must have a diagnosis of B-ALL by flow cytometry, or bone marrow histology, and/or cytogenetics. * Patients must have CD19+ ALL as confirmed by flow cytometry and/or immunohistochemistry. * Creatinine \< 2.0 mg/100 ml, bilirubin \< 2.0 mg/100 ml, AST and ALT \< 3x normal, PT and PTT \< 2x normal outside the setting of stable chronic anticoagulation therapy. LFTs (Bilirubin, AST, and/or ALT) may be acceptable if the elevation is secondary to leukemia infiltration or leukemia therapy with tyrosine kinase inhibitors. * Adequate cardiac function (LVEF ≥ 40%) as assessed by ECHO or MUGA or other similar cardiac imaging performed within 1 month of enrollment. * Adequate pulmonary function as assessed by ≥ 92% oxygen saturation on room air by pulse oximetry. * Patients must have adequate access for leukapheresis procedure as assessed by staff from the MSKCC Donor Room. * Life expectancy \> 3 months Exclusion Criteria: * Karnofsky performance status \< 70. * Active central nervous system (CNS) leukemia, as defined by unequivocal morphologic evidence of lymphoblasts in the cerebrospinal fluid (CSF) or symptomatic CNS leukemia (i.e. cranial nerve palsies or other significant neurologic dysfunction) within 28 days of enrollment. Prophylactic intrathecal medication is not a reason for exclusion. * Patients previously treated with an allogeneic SCT that is currently complicated by active GVHD requiring T cell suppressive therapy. Patients with following cardiac conditions will be excluded: * New York Heart Association (NYHA) stage III or IV congestive heart failure * Myocardial infarction ≤6 months prior to enrollment * History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration * History of severe non-ischemic cardiomyopathy with EF ≤20% * Patients with HIV, hepatitis B or hepatitis C infection. * Patients with any concurrent active malignancies as defined by malignancies requiring any therapy other than expectant observation.
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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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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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Other studies related to the condition(s) this trial covers.
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