Engineered immune cells take on bone marrow cancer
NCT ID NCT03070327
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tests a new treatment for multiple myeloma, a type of blood cancer. It uses a patient's own immune cells, modified to target a protein called BCMA on cancer cells, and may be combined with a drug called lenalidomide. The main goal is to find the safest dose and check for side effects in up to 20 adults whose cancer has not responded to prior therapies.
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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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20 people
The number who actually took part.
- Started
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Feb 2017
- Expected to finish
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Feb 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 histologically confirmed MM by MSKCC pathologist, with MM cells expressing BCMA, previously treated with 2+ prior lines of therapy including an IMiD and a PI, either with refractory, persistent, or progressive disease * Age ≥ 18 years of age * Creatinine ≤2.0 mg/dL, direct bilirubin ≤2.0 mg/dL, 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. * HGB≥7g/dl, ANC≥1,000/mm3, Platelet≥30,000/mm3 without transfusion or growth factor support for at least 1 week * M spike ≥0.5 g/dL or involved free light chain ≥10 mg/dL with an abnormal free light chain ratio 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 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 * Patients with HIV or active hepatitis B or hepatitis C 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 a prior allogeneic transplant ARE eligible UNLESS previously or currently experienced GvHD that required systemic steroids or other systemic lymphotoxic therapy * Patients on systemic steroids (except if solely for adrenal replacement) within two weeks of collection * Active auto-immune disease including connective tissue disease, uveitis, sarcoidosis, inflammatory bowel disease, or multiple sclerosis, or have a history of severe (as judged by the principal investigator) autoimmune disease requiring prolonged immunosuppressive therapy * Prior treatment with gene modified T cells * Prior or active CNS involvement by myeloma (eg leptomeningial disease). Screening for this, for example, by lumbar puncture, is only required if suspicious symptoms or radiographic findings are present * Plasma cell leukemia * Pre-existing (active or severe) neurologic disorders (e.g. pre-existing seizure disorder) * Active uncontrolled acute infections * Any other issue which, in the opinion of the treating physician, would make the patient ineligible for the study * Patients who previously had any intolerance to Lenalidomide 10 mg or who have a contraindication to Lenalidomide will not be eligibile for concominant treatment with Lenalidomide but will remain eligible for CAR T cell therapy without Lenalidomide.
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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.
- Bispecific antibody combo aims to deepen myeloma responses
- Can a stronger drug cocktail give older myeloma patients a better start?
- Cheap blood count ratios eyed as window into Myeloma's inflammatory grip
- Can a t-cell engager rescue myeloma that outsmarted CAR-T?
- Can myeloma treatment work without steroids?
- Double-Drug attack on Hard-to-Treat lymphomas