Phase I/II Study of Autologous T Cells to Express T-Cell Receptors (TCRs) in Subjects With Solid … (NCT05194735) | Clinical Trial Compass
TerminatedPhase 1/2
Phase I/II Study of Autologous T Cells to Express T-Cell Receptors (TCRs) in Subjects With Solid Tumors
Stopped: Funding
United States8 participantsStarted 2022-04-04
Plain-language 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
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
✓. 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:
✓. Ovarian cancer
✓. Endometrial cancer
✓. 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.
✓. Patients must be able to provide written informed consent.
✓. Patients must be age ≥ 18 years.
✓. Clinical Performance Status of ECOG 0 or 1. Approval from the Alaunos Medical Monitor is required for ECOG of 2.
Exclusion criteria
✕. Patients with known active CNS metastases
✕. Concurrent systemic steroid therapy
✕. Any form of primary immunodeficiency
✕. Patients who have decreased immune competence
What they're measuring
1
Number of Participants With Treatment-Emergent Adverse Events
Timeframe: From initiation of lymphodepletion through Day 28 after TCR-T cell infusion, and through long-term follow-up for up to 1 year.
2
Frequency of Dose Limiting Toxicities
Timeframe: From Day 0 to Day 28 post TCR-T cell drug product infusion.
3
Determination of Maximum Tolerated Dose (MTD) or Recommended Phase II Dose (RP2D)
Timeframe: From Day 0 to Day 28 post TCR-T cell drug product infusion.
. History of severe immediate hypersensitivity reaction to cyclophosphamide, fludarabine, aldesleukin or bendamustine
✕. Severe chronic respiratory condition
✕. History of a bleeding disorder or unexplained major bleeding diathesis
✕. 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;