Supercharged immune cells take on Hard-to-Treat cancers
NCT ID NCT05296564
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tests a personalized cell therapy for people with several types of advanced cancer that have spread and express a protein called NY-ESO-1. Participants receive a single infusion of their own immune cells that have been genetically modified to recognize and attack cancer cells. The main goals are to check safety and see if tumors shrink.
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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 3 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2022
- Expected to finish
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Dec 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 to 70 years
- 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: 1. Have histologically or cytologically confirmed diagnosis of neoplasia 2. Measurable (per RECIST v1.1 criteria) metastatic cancer or locally advanced refractory/recurrent malignancy not amenable to curative treatment. Lesions previously irradiated may be considered measurable only if growth has been documented since local treatment completion. 3. The tumor expresses ESO as assessed immunohistochemistry of resected tissue. To this end, archived tumor tissue suitable for analysis must be available or re-biopsy performed on study. Tissue staining must encompass more than 10% of tumor section. 4. Patients must have previously either (1) received at least first-line or second-line standard therapy for metastatic disease, if known to be effective for that disease, and have been either non-responders (progressive disease), intolerable or have recurred or (2) Recurred within 6 months of adjuvant systemic therapy known to be active also in the metastatic setting. 5. Patients with 3 or fewer brain metastases that are less than 1 cm in diameter and asymptomatic are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for 1 month after treatment for the patient to be eligible. Patients with surgically resected brain metastases are eligible. 6. More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the preparative regimen, and patients' toxicities must have recovered to a grade 1 or less (except for toxicities such as alopecia or vitiligo). 7. Age ≥ 18 years and ≤ 70 years. 8. Patient is able to understand and willing to sign a written informed consent. 9. Clinical performance status of ECOG 0, 1 or 2. 10. HLA-A\*0201or A\*0206 positive. 11. Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for four months after treatment. 12. Women of child-bearing potential must have a negative pregnancy test. 13. Serology: Seronegative for HIV antibody, hepatitis B antigen, and hepatitis C antibody. If hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by RT-PCR and be HCV RNA negative. 14. Hematology * ANC \> 1500/mm3 without the support of filgrastim * WBC ≥ 3000/mm3 * Platelet count ≥ 100,000/mm3 * Hemoglobin \> 8.0 g/dL. Subjects may be transfused to reach this cut-off. 15. Chemistry * Serum ALT/AST ≤ 2.5 x ULN * Creatinine clearance ≥40ml/min * Total bilirubin ≤ 1.5 mg/dL, except in patients with Gilbert's Syndrome, who must have a total bilirubin \< 3.0 mg/dL. * INR \< 1.5 Exclusion Criteria: 1. Women of child-bearing potential who are pregnant or breastfeeding. 2. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease). 3. Active systemic infections requiring anti-infective treatment, coagulation disorders, or any other active or uncompensated major medical illnesses 4. Concurrent systemic steroid therapy, not including replacement therapy or treatment with prednisone up to 10mg daily or its equivalent. Or any other form of immunosuppressive therapy within 7 days before the first dose of study intervention. 5. History of severe immediate hypersensitivity reaction to cyclophosphamide, fludarabine, or aldesleukin. 6. Subjects with a history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within 3 months. 7. Subjects unable to maintain normal oxygen saturation level in room air. 8. Subjects who have had a venous thromboembolic event requiring anticoagulation and who meet any of the following criteria: * Have been on a stable dose of anticoagulation for \< 1 month (except for acute line insertion induced thrombosis). * Have had a Grade 2, 3, or 4 hemorrhage in the last 30 days or are experiencing continued symptoms from their venous thromboembolic event (e.g. continued dyspnea or oxygen requirement). 9. Has a known additional malignancy within the last 3 years. Exceptions include early stage cancers (carcinoma in situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, or in situ breast cancer that has undergone potentially curative therapy). 10. LVEF ≤ 40% 11. Documented FEV1 ≤ 60% predicted tested in patients with: * A prolonged history of cigarette smoking (≥ 20 pack-year smoking history, with cessation within the past two years). * Symptoms of respiratory dysfunction. 12. Patients who are at the time of study initiation receiving any other investigational agents. 13. Carcinomatosis meningitis or other brain involvement exceeding that allowed above. 14. Has received live vaccine within 30 days before the first dose of study intervention. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hadassah Medical Organization
RECRUITINGJerusalem, 9112001, Israel
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