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NCT05194735 · REGISTRY CONDITION SEARCH

Phase I/II Study of Autologous T Cells to Express T-Cell Receptors (TCRs) in Subjects With Solid Tumors

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE1, PHASE2
Status at capture
TERMINATED
Registry last update
2025-11-10

A Phase I/II study of autologous T cells engineered using the Sleeping Beauty transposon/transposase system to express TCR(s) reactive against neoantigens in subjects with relapsed/refractory solid tumors

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With Treatment-Emergent Adverse Events

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outcome · POSTED

Frequency of Dose Limiting Toxicities

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outcome · POSTED

Determination of Maximum Tolerated Dose (MTD) or Recommended Phase II Dose (RP2D)

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outcome · POSTED

Feasibility of TCR-T Cell Drug Product Manufacturing

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outcome · POSTED

TCR-T Cell Persistence

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outcome · POSTED

Percent Change in TCR-T Cell Count From Post Dose to Day 28

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
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
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    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
    intervention Names
    1. Biological: Neoantigen specific TCR-T cell drug product
    label
    TCR-T Cell Drug Product
    type
    EXPERIMENTAL
  2. description
    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
    intervention Names
    1. Biological: Neoantigen specific TCR-T cell drug product
    2. Biological: Aldesleukin (IL-2)
    label
    TCR-T Cell Drug Product with Aldesleukin (IL-2)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. TCR-T Cell Drug Product
    2. TCR-T Cell Drug Product with Aldesleukin (IL-2)
    description
    Phase I: Ascending dose, single Infusion of TCR+ Cells Phase II: Single infusion at the RP2D
    name
    Neoantigen specific TCR-T cell drug product
    type
    BIOLOGICAL
  2. arm Group Labels
    1. TCR-T Cell Drug Product with Aldesleukin (IL-2)
    description
    To support growth and activation of TCR-T cell drug product
    name
    Aldesleukin (IL-2)
    type
    BIOLOGICAL
Study design
allocation
NON_RANDOMIZED
intervention Model
SEQUENTIAL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
8
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Treatment-emergent adverse events (TEAEs) were defined as any adverse event that began or worsened after initiation of lymphodepletion and up to 28 days following TCR-T cell infusion. TEAEs were coded using MedDRA and summarized by system organ class and preferred term, severity, and relationship to study treatment. Participants were followed for delayed or ongoing toxicities for up to 1 year.
    measure
    Number of Participants With Treatment-Emergent Adverse Events
    time Frame
    From initiation of lymphodepletion through Day 28 after TCR-T cell infusion, and through long-term follow-up for up to 1 year.
  2. description
    Number of participants experiencing DLTs, defined as specific adverse events attributable to the TCR-T cell drug product occurring within the first 28 days of infusion. DLTs include, but are not limited to, Grade 4 neutropenia lasting ≥ 14 days, Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with significant bleeding, and ≥ Grade 3 febrile neutropenia with hemodynamic compromise. Non-hematologic DLTs include Grade 3 or 4 Cytokine Release Syndrome (CRS) that does not improve to Grade ≤ 2 within 72 hours, and Grade 3 Immune-effector cell-associated neurotoxicity syndrome (ICANS) that does not resolve to Grade ≤ 2 within 7 days, among others. The severity of adverse events will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
    measure
    Frequency of Dose Limiting Toxicities
    time Frame
    From Day 0 to Day 28 post TCR-T cell drug product infusion.
  3. description
    The MTD and/or RP2D was to be determined based on dose-limiting toxicities observed during the dose-escalation phase. The planned definition required ≥2 patients at a given dose level to experience a DLT to declare that dose not tolerated.
    measure
    Determination of Maximum Tolerated Dose (MTD) or Recommended Phase II Dose (RP2D)
    time Frame
    From Day 0 to Day 28 post TCR-T cell drug product infusion.
secondary Outcomes
  1. description
    Feasibility will be assessed by the number of participants who met eligibility criteria at each step of the manufacturing process, including inability to undergo apheresis, failure of product manufacture, manufactured product not infused, and successful manufacture and infusion of TCR-T cell drug product.
    measure
    Feasibility of TCR-T Cell Drug Product Manufacturing
    time Frame
    From apheresis collection to the release of the final TCR-T cell drug product for infusion, estimated to be approximately 5 weeks
  2. description
    Persistence of TCR-T cells in peripheral blood was assessed by quantitative PCR for vector copy number per 1 × 10⁶ cells at baseline (1 week prior to infusion), predose (Day 0), and multiple post-infusion time points through Month 18. Only quantifiable values are summarized. Samples with "Not Detected (ND)" or "Below the Limit of Quantitation (BLOQ)" are reported as NA and excluded from summary statistics.
    measure
    TCR-T Cell Persistence
    time Frame
    Baseline through Month 18 post-infusion.
  3. description
    Assessed by comparing each participant's highest post-dose TCR-T cell count (copies per 1×10⁶ cells by qPCR) to the TCR-T cell count at Day 28. Percent change was calculated as: ((Day 28 - peak post-dose) / peak post-dose) × 100.
    measure
    Percent Change in TCR-T Cell Count From Post Dose to Day 28
    time Frame
    Post-dose through Day 28
Full study description
brief Summary
A Phase I/II study of autologous T cells engineered using the Sleeping Beauty transposon/transposase system to express TCR(s) reactive against neoantigens in subjects with relapsed/refractory solid tumors
detailed Description
A Phase I/II study of autologous T cells engineered using the Sleeping Beauty transposon/transposase system to express TCR(s) reactive against neoantigens in subjects with relapsed/refractory solid tumors. 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
Source references
references
  1. citation
    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.
    pmid
    35537408
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice