Experimental cell therapy takes on Hard-to-Treat myeloma
NCT ID NCT04674813
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial tested a new cell therapy called CC-95266 in 130 people with multiple myeloma that had come back or stopped responding to treatment. Participants also received chemotherapy drugs to prepare their bodies for the cell infusion. The main goals were to check safety and find the right dose, while also looking at how well the treatment worked.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CC-95266 (a cell therapy) given with chemotherapy drugs fludarabine, cyclophosphamide, and bendamustine
- What this could lead to
- If successful, this could point toward a new treatment option for people with multiple myeloma that has not responded to other therapies.
- What could go wrong
- This is an early phase 1 trial focused on safety, so it is too soon to know if the treatment works. Side effects from the cell therapy and chemotherapy may be significant.
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
-
130 people
The number who actually took part.
- Started
-
Feb 2021
- Finished
-
Dec 2025
- 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 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: * Age ≥ 18 years * Participant has a diagnosis of multiple myeloma (MM) with relapsed and/or refractory disease. Participants must have confirmed progressive disease (as per IMWG criteria) on or within 12 months of completing treatment with the last anti-myeloma treatment regimen before study entry or have confirmed progressive disease within 6 months prior to screening and who are subsequently determined to be refractory or non-responsive to their most recent anti-myeloma treatment regimen, except for participants with cellular therapy (e.g., Chimeric antigen receptor (CAR) T-cell therapy) as their last treatment, who may enroll beyond 12 months. * Participants in Part A, and Part B Cohort A, and Part B Cohort B must have received at least 3 prior anti-myeloma treatment regimens (note: induction with or without hematopoietic stem cell transplant (HSCT) and with or without maintenance therapy is considered one regimen).Subjects in Part B Cohort C only must have received at least 1 but not greater than 3 prior anti-myeloma treatment regimens, including a proteasome inhibitor and immunomodulatory agent including: * Autologous HSCT, unless the subject was ineligible * A regimen that included an immunomodulatory agent (e.g., thalidomide, lenalidomide, pomalidomide) and a proteasome inhibitor (e.g., bortezomib, carfilzomib, ixazomib), either alone or combination * Anti-CD38 (e.g., daratumumab), either alone or combination. Subjects in Cohort C do not require prior anti-CD38 antibody therapy. * Measurable disease * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Adequate organ function Exclusion Criteria: * Known active or history of central nervous system (CNS) involvement of MM * Active or history of plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) syndrome, or clinically significant amyloidosis * Active autoimmune disease requiring immunosuppressive therapy * History or presence of clinically significant CNS pathology such as seizure disorder, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, or psychosis Other protocol-defined inclusion/exclusion criteria apply.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Multiple myeloma are added.
Genom att skicka in godkänner du våra Användarvillkor
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
-
Local Institution - 001
Nashville, Tennessee, 37203, United States
-
Local Institution - 002
Denver, Colorado, 80218, United States
-
Local Institution - 003
Seattle, Washington, 98104, United States
-
Local Institution - 005
Birmingham, Alabama, 10016, United States
-
Local Institution - 006
Dallas, Texas, 75390, United States
-
Local Institution - 008
Baltimore, Maryland, 21201, United States
-
Local Institution - 009
Duarte, California, 91010-301, United States
-
Local Institution - 010
Boston, Massachusetts, 02215, United States
-
Local Institution - 011
New York, New York, 10029, United States
-
Local Institution - 012
San Francisco, California, 94143, 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