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Engineered stem cell therapy takes on Hard-to-Treat myeloma

NCT ID NCT05182073

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

31 people

The number who actually took part.

Started

Nov 2021

Finished

Oct 2024

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • City of Hope

    Duarte, California, 91010, United States

  • Indiana University

    Indianapolis, Indiana, 46202, United States

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Medical Oncology Hematology Consultants

    Newark, Delaware, 19713, United States

  • Oncology Hematology Care, Inc

    Cincinnati, Ohio, 45226, United States

  • Roswell Park

    Buffalo, New York, 14263, United States

  • Scri-Cbci

    Denver, Colorado, 80218, United States

  • Tennessee Oncology - Nashville

    Nashville, Tennessee, 37203, United States

  • Texas Oncology-Medical City Dallas

    Dallas, Texas, 75230, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35205, United States

  • University of Minnesota

    Saint Paul, Minnesota, 55108, United States

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502, United States

  • Washington University

    St Louis, Missouri, 63130, United States

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