Armored immune cells take on tough blood cancers in early trial
NCT ID NCT03085173
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tests the safety of specially engineered immune cells (armored CAR T cells) in people with certain blood cancers that have not responded to standard treatments. The cells are made from the patient's own blood and designed to better target and attack cancer cells. The study aims to find a safe dose and see how the treatment affects the cancer.
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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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39 people
The number who actually took part.
- Started
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Mar 2017
- Expected to finish
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Mar 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: * Patients must have CD19+ B cell malignancy with relapsed or refractory disease, defined as below: Patients with CLL: * Refractory to or relapsed after at least 2 prior chemo or chemoimmunotherapy (e.g. FCR, BR) requiring further treatment * Refactory to or relapsed after at least 1 prior biologic agent (e.g. Ibrutinib, idelalisib, venetoclax, except a single agent anti-CD20 monoclonal antibody) requiring further treatment Patients with iNHL (FZ, MZL, WM): * Refractory or relapsed after at least 2 lines of chemoimmunotherapy (including at least one course of anti-CD20 antibody) * Refractory or relapsed after at least 1 prior biologic agent (e.g. lenalidomide, ibrutinib, idelalisib) * Patients must have measurable disease (for WM patients, measureable disease is demonstrable monoclonal paraprotein and bone marrow involvement) Patients with DLBCL, Transformed B cell lymphoma, or High grade B cell lymphoma: * Refractory to or relapsed after 1 or more prior chemoimmunotherapies with at least one containing an anthracycline and CD20 directed therapy * Transplant ineligible * Biopsy proven relapsed disease Patients with ALL, CML in lymphoid blast crisis or Burkitt's lymphoma: * Refractory to at least 1 prior induction chemotherapy * Relapsed after at least 1 prior multiagent systemic chemotherapy that included induction and consolidation * Patients with Philadelphia chromosome-positive ALL must have failed a second generation tyrosine kinase inhibitor * Age ≥ 18 years of age * Creatinine ≤2.0 mg/100 ml, direct bilirubin ≤2.0 mg/100 ml, AST and ALT ≤3.0x upper limit of normal (ULN) * Adequate pulmonary function as assessed by ≥92% oxygen saturation on room air by pulse oximetry Exclusion Criteria: * Karnofsky performance status \<70 * Pregnant or lactating women. Women and men of childbearing age should use effective contraception while on this study and continue for 1 year after all treatment is finished * Impaired cardiac function (LVEF \<40%) as assessed by ECHO or MUGA scan * Patients with active known autoimmune disease are ineligible * 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 \<6 months prior to enrollment * History of severe non-ischemic cardiomyopathy with EF \</=20% * Patients with HIV or active hepatitis B or hepatitis C infection are ineligible * Patients with uncontrolled systemic fungal, bacterial, viral or other infection are ineligible * Patients with any concurrent active malignancies as defined by malignancies requiring any therapy other than expectant observation or hormonal therapy, with the exception of squamous and basal cell carcinoma of skin * Patients with history or presence of clinically significant neurological disorders such as epilepsy, generalized seizure disorder, severe brain injuries are ineligible * Any other issue which, in the opinion of the treating physician, would make the patient ineligible for the 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.
Contacts and locations
Locations
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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