Donor immune cells take on Hard-to-Treat cancers in early trial
NCT ID NCT05239143
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial is testing a new type of cell therapy called P-MUC1C-ALLO1 for people with advanced solid tumors (like breast, ovarian, lung, or pancreatic cancer) that have not responded to other treatments. The therapy uses donor immune cells engineered to recognize and attack cancer cells. The main goals are to find a safe dose and see if the treatment can shrink tumors. About 180 adults are taking part.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- P-MUC1C-ALLO1 CAR-T cells (a type of immune cell therapy made from donor cells, designed to attack cancer cells that have a protein called MUC1-C)
- What this could lead to
- If this works, it could point toward a new treatment option for several hard-to-treat cancers that have spread or come back.
- What could go wrong
- This is a very early (Phase 1) trial with only 180 people, so it is mainly checking safety and dosing. The therapy may not shrink tumors, and there could be serious side effects like cytokine release syndrome or immune reactions.
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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About 180 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2022
- Expected to finish
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Apr 2039
An estimate. End dates often move.
- 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.
Inclusion Criteria: * Males or females, Subjects ≥18 years with life expectancy \>3 months * Must have a confirmed diagnosis of unresectable, locally advanced or metastatic epithelial-derived cancer * Must have progressed during or after last therapy, developed intolerance/toxicity to current treatment, or ineligible or refused other existing treatment options, and have measurable disease * Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 or Karnofsky performance status ≥70% * Must have adequate vital organ function within pre-determined parameters * Must have archived tumor tissue available or consent to a biopsy collection * Must be willing to practice birth control * Must have a negative pregnancy test at screening and prior to initiating lymphodepletion chemotherapy or study drug administration * Must have recovered from toxicities due to prior therapies Exclusion Criteria: * Has inadequate venous access * Has an active second malignancy (not disease free for at least 5 years) in addition to the studied malignancy, excluding low-risk neoplasms such as non-metastatic basal cell or squamous cell skin carcinoma * Is pregnant or lactating * Has a history of or active autoimmune disease * Has a history of significant central nervous system (CNS) disease, such as stroke, epilepsy * Has an active systemic (viral, bacterial, or fungal) infection * Has New York Heart Association (NYHA) Class III or IV heart failure, unstable angina, or a history of myocardial infarction or significant arrhythmia * Has any psychiatric or medical disorder that would preclude safe participation in and/or adherence to the protocol * Has received anticancer medications within 2 weeks of the time of initiating lymphodepletion * Has received immunosuppressive medications within 2 weeks of administration of P-MUC1C-ALLO1, and/or expected to require them while enrolled in the study * Has received systemic corticosteroid therapy within 1 week of the administration of P-MUC1C-ALLO1 or is expected to require it during the course of the study * Has known CNS metastases or symptomatic CNS involvement * Has a history of significant liver disease or active liver disease * Has a history of known genetic predisposition to HLH/MAS * Has received anti-cancer monoclonal antibody therapy within 4 weeks of initiating LD therapy
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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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Cancer Center of Kansas
Wichita, Kansas, 67214, United States
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Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
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Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
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MD Anderson Cancer Center
Houston, Texas, 77030, United States
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Montefiore Medical Center
The Bronx, New York, 10467, United States
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NEXT Oncology
San Antonio, Texas, 78229, United States
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Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218, United States
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University of California, Irvine Medical Center
Irvine, California, 92868, United States
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University of California, San Diego
San Diego, California, 92037, United States
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University of California, San Francisco
San Francisco, California, 94143, United States
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University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
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University of Kansas Cancer Center
Westwood, Kansas, 66205, United States
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University of Maryland Cancer Center
Baltimore, Maryland, 21201, United States
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University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
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Other studies related to the condition(s) this trial covers.
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