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Cancer-Fighting super cells tested in solid tumors – study halted early

NCT ID NCT05194735

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 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.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

8 people

The number who actually took part.

Started

Apr 2022

Finished

Aug 2023

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.

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

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.