Engineered stem cell therapy takes on Hard-to-Treat myeloma
NCT ID NCT05182073
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This early-stage trial tested a new therapy called FT576, made from specially engineered stem cells that become cancer-fighting immune cells. It was given alone or with another drug, daratumumab, to 31 people with multiple myeloma that had returned or stopped responding to prior treatments. The goal was to find a safe dose and see if the therapy could shrink the cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- FT576 (engineered immune cells from stem cells) and daratumumab (a targeted antibody)
- What this could lead to
- If successful, this could point toward a new treatment option for multiple myeloma that has stopped responding to other therapies.
- What could go wrong
- This is an early Phase 1 trial with only 31 participants, so safety and effectiveness are not yet proven. The treatment may cause side effects or fail to control the cancer.
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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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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31 people
The number who actually took part.
- Started
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Nov 2021
- Finished
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Oct 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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.
* Abbreviated inclusion criteria: Diagnosis of r/r MM with measurable disease by at least one of the following: * Serum M-protein ≥1.0 g/dL * Urine M-protein ≥200 mg/24 hours * Involved serum free light chain level ≥10 mg/dL, with an abnormal kappa-lambda ratio if the serum M-protein \<1.0 g/dL and/or urine M-protein \<200 mg/24 hours * Regimens A - A4 only: MM relapsed or progressed after ≥3 prior approved therapies, including an IMiD, proteosome inhibitor, and anti-CD38 mAb * Regimens B - B4 only: MM relapsed or progressed after ≥2 prior approved therapies, including an IMiD and proteosome inhibitor Note: for all Regimens, prior BCMA CAR T-cell therapy and BCMA-targeted therapy (e.g., bi-specific engagers or antibody-drug conjugates) is allowed \* Abbreviated exclusion criteria: Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≥2 Evidence of insufficient hematologic function: * ANC \<1000/µL without growth factor support ≤7 days prior to measurement * Platelet count \<75,000/µL without platelet transfusion ≤72 hours prior to measurement Evidence of insufficient organ function * CrCL \<50 ml/min by Cockcroft-Gault or other institutional method * T bilirubin \>1.5x ULN, except for Gilbert's syndrome * AST \>3x ULN or ALT \>3x ULN, unless directly due to underlying malignancy * O2 sat \<92% on room air Clinically significant cardiovascular disease: * Myocardial infarction within 6 months of first treatment * Unstable angina or CHF of NYHA Grade 2 or higher * Cardiac EF \<40% Subjects with active central nervous system (CNS) , including leptomeningeal disease. Subjects with prior CNS involvement may be enrolled into the study if effective treatment of their CNS disease was completed at least 3 months prior to Day 1 with no evidence of disease clinically and at least stable findings on relevant CNS imaging. Non-malignant CNS disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease or receipt of medications for these conditions in the 2-year period leading up to study enrollment Currently receiving or likely to require immunosuppressive therapy (e.g., prednisone \>5 mg daily) for any reason during the treatment period, with the exception of inhaled corticosteroids. Clinically significant infections, including: * HIV positive by serology * HBV positive by serology or PCR * HCV positive by serology or PCR Live vaccine \<6 weeks prior to start of conditioning Receipt of an allograft organ transplant Ongoing requirement for systemic graft -versus-host disease therapy Plasma cell leukemia defined as a plasma cell count \>2000/mm\^3 Prior malignancy (other than current indication including any antecedent hematologic disorder) within the 2 years prior to enrollment except for the following: basal or squamous cell carcinomas of the skin, carcinoma in situ of the cervix or breast treated with curative intent, or localized prostate cancer treated with curative intent, or malignancy that, in the opinion of the investigator and Sponsor's Medical Monitor, is considered cured with minimal risk of recurrence within 3 years. Washout periods from prior therapies: \- Chemotherapy, or radiation therapy, except for palliative purposes, within 14 days prior to the first dose of FT576 (Day 1) or five half-lives, whichever is shorter; Investigational therapy within 30 days prior to the first dose of FT576 study treatment or five half-lives, whichever is shorter; Biologic therapy (e.g., anti-CD38 mAbs or anti-SLAMF7 monoclonal antibodies), including autologous cellular immunotherapy (e.g. CAR-T/ CAR-NK), antibody-drug conjugates or bi-specific immune-cell engaging antibody within 30 days prior to first dose of FT576 (Day 1) or half -lives whichever is shorter. prior allogenic HSCT or allogenic CAR-T/CAR-NK within 6 months of first dose of FT576 (Day1).
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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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City of Hope
Duarte, California, 91010, United States
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Indiana University
Indianapolis, Indiana, 46202, United States
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Levine Cancer Institute
Charlotte, North Carolina, 28204, United States
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Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
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Medical Oncology Hematology Consultants
Newark, Delaware, 19713, United States
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Oncology Hematology Care, Inc
Cincinnati, Ohio, 45226, United States
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Roswell Park
Buffalo, New York, 14263, United States
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Scri-Cbci
Denver, Colorado, 80218, United States
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Tennessee Oncology - Nashville
Nashville, Tennessee, 37203, United States
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Texas Oncology-Medical City Dallas
Dallas, Texas, 75230, United States
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University of Alabama at Birmingham
Birmingham, Alabama, 35205, United States
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University of Minnesota
Saint Paul, Minnesota, 55108, United States
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Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
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Washington University
St Louis, Missouri, 63130, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- 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
- Banking blood and bone marrow to decode plasma cell disorders
- Which scan sees hidden myeloma better: PET or MRI?