Phase I/II Study of Autologous T Cells to Express T-Cell Receptors (TCRs) in Subjects With Solid Tumors
NCT ID: NCT05194735
Last Updated: 2025-11-10
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
8 participants
INTERVENTIONAL
2022-04-04
2023-08-14
Brief Summary
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Detailed Description
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An HLA Typing and Tumor Neoantigen Mutation Testing Protocol (Protocol # TCR001-002) has been used to identify patients for potential enrollment into this Study Protocol. Subjects who have completed the HLA Typing and Tumor Neoantigen Mutation Testing Protocol, i.e., subjects for whom a TCR matching the subject's somatic mutation(s) and HLA type restriction combination is available in Alaunos' TCR library will be eligible for enrollment on this study.
The Phase I part of this study is a prospective, open-label, dose-escalation study of TCR-T cell drug product in patients with progressive or recurrent solid tumors who have failed standard therapy. The Phase II part is a prospective, open-label, single dose portion of the study. The Phase II part will begin once the MTD/RP2D in the Phase I part has been determined.
Subjects with one of the following histologically confirmed solid tumors will be included:
* Cohort 1: Gynecologic cancer (e.g., ovarian, endometrial)
* Cohort 2: Colorectal cancer
* Cohort 3: Pancreatic cancer
* Cohort 4: Non-small cell lung cancer (NSCLC); NSCLC includes but is not limited to squamous cell carcinoma, adenosquamous carcinoma or adenocarcinomas
* Cohort 5: Cholangiocarcinoma
Subject must have a tumor mutation and HLA typing combination that matches to at least one of the following TCRs in the Alaunos' library (mutation \& HLA type):
* KRAS G12D \& HLA-A\*11:01
* KRAS G12D \& HLA-C\*08:02
* KRAS G12V \& HLA-A\*11:01
* KRAS G12V \& HLA-C\*01:02
* TP53 R175H \& HLA-A\*02:01
* TP53 R175H \& HLA-DRB1\*13:01
* TP53 R248W \& HLA-A\*68:01
* TP53 Y220C \& HLA-A\*02:01
* TP53 Y220C \& HLA-DRB3\*02:02
* EGFR E746-A750del \& HLA-DPA1\*02:01, DPB1\*01:01
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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TCR-T Cell Drug Product
Phase I: Dose-escalation of TCR-T Cell Drug Product
Phase II: Single dose of TCR-T Cell Drug Product after MTD/RP2D determine in Phase I portion of the study
Neoantigen specific TCR-T cell drug product
Phase I:
Ascending dose, single Infusion of TCR+ Cells
Phase II:
Single infusion at the RP2D
TCR-T Cell Drug Product with Aldesleukin (IL-2)
Phase I: Dose-escalation of TCR-T Cell Drug Product with Aldesleukin (IL-2)
Phase II: Single dose of TCR-T Cell Drug Product with Aldesleukin (IL-2) after MTD/RP2D determine in Phase I portion of the study
Neoantigen specific TCR-T cell drug product
Phase I:
Ascending dose, single Infusion of TCR+ Cells
Phase II:
Single infusion at the RP2D
Aldesleukin (IL-2)
To support growth and activation of TCR-T cell drug product
Interventions
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Neoantigen specific TCR-T cell drug product
Phase I:
Ascending dose, single Infusion of TCR+ Cells
Phase II:
Single infusion at the RP2D
Aldesleukin (IL-2)
To support growth and activation of TCR-T cell drug product
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Alaunos Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Scott Kopetz, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
MD Anderson
Locations
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MD Anderson Cancer Center
Houston, Texas, United States
Countries
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References
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Levy PL, Gros A. Fast track to personalized TCR T cell therapies. Cancer Cell. 2022 May 9;40(5):447-449. doi: 10.1016/j.ccell.2022.04.013. Epub 2022 May 9.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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TCR001-201
Identifier Type: -
Identifier Source: org_study_id