Cancer-Fighting super cells tested in solid tumors – study halted early
NCT ID NCT05194735
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a personalized treatment where a patient's own immune cells were modified in a lab to recognize and attack unique markers on their cancer cells. It involved 8 people with advanced solid tumors like lung, pancreatic, or ovarian cancer that had not responded to standard treatments. The main goals were to check safety and find the best dose, but the study was stopped early.
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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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8 people
The number who actually took part.
- Started
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Apr 2022
- Finished
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Aug 2023
- 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
-
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: 1. Patients who have completed the HLA Typing and Tumor Neoantigen Identification Protocol (TCR001-002) and for whom a TCR(s) matching the subject's somatic mutation(s) and HLA type restriction combination is available in Alaunos' Clinical TCR library 2. Patients who have previously received at least one line of standard systemic therapy for their advanced/metastatic cancer and have either progressed, recurred, or were intolerant to the previous treatment. Specifically: * Subgroup 1. Gynecologic cancers (i.e., ovarian or endometrial): 1. Ovarian cancer 2. Endometrial cancer * Subgroup 2. Colorectal cancer * Subgroup 3. Pancreatic cancer * Subgroup 4. Non-small cell lung cancer (NSCLC) * Subgroup 5. Cholangiocarcinoma 3. Patients must have evaluable or measurable disease per RECIST 1.1 with at least one lesion that can be measured that is not the biopsied lesion. 4. Patients must be able to provide written informed consent. 5. Patients must be age ≥ 18 years. 6. Clinical Performance Status of ECOG 0 or 1. Approval from the Alaunos Medical Monitor is required for ECOG of 2. 7. Patient must be willing and able to provide written informed consent for the long-term follow-up protocol (TCR001-202) for up to 15 years post TCR-T Cell drug product infusion per FDA requirements. 8. Adequate bone marrow reserves as assessed by the following hematology laboratory criteria: 9. Adequate major organ system function 10. A washout period must have elapsed since completion of any prior systemic therapy, and apheresis with guidelines as follows (windows other than what is listed below should be allowed only after consultation with the Medical Monitor); subjects' non-hematologic toxicities from any prior systemic therapy must have recovered to ≤ Grade 1 (with the exception of neuropathy and alopecia) or baseline prior to starting the protocol's therapy. 11. Patients may have undergone minor surgical procedures or limited-field radiotherapy provided any major organ toxicities have recovered to ≤ Grade 1. 12. Female patients must not be pregnant or breastfeeding. Exclusion Criteria: 1. Patients with known active CNS metastases 2. Concurrent systemic steroid therapy 3. Any form of primary immunodeficiency 4. Patients who have decreased immune competence 5. History of severe immediate hypersensitivity reaction to cyclophosphamide, fludarabine, aldesleukin or bendamustine 6. Severe chronic respiratory condition 7. History of a bleeding disorder or unexplained major bleeding diathesis 8. Arm B Criteria only: Clinically significant patient history which in the judgment of the principal investigator (PI) would compromise the subject's ability to tolerate high-dose aldesleukin; 9. Any major bronchial occlusion or bleeding not amenable to palliation. 10. Patients with psychiatric illness/social situations at the time of treatment that would limit compliance with study requirements. 11. Participants with known active, uncontrolled bacterial, fungal, or viral infection 12. Patients with a prior history or concurrent malignancy 13. Active unstable or clinically significant medical condition 14. History of any major cardiovascular conditions within the past 6 months
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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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MD Anderson Cancer Center
Houston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Two-Drug combo targets stubborn KRAS lung cancer
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- Gut bacteria may hold clues to why some cancer treatments work better