Ovarian Cancer Clinical Trial

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

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

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Full 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

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Eligibility Criteria

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:

Subgroup 1. Gynecologic cancers (i.e., ovarian or endometrial):

Ovarian cancer
Endometrial cancer
Subgroup 2. Colorectal cancer
Subgroup 3. Pancreatic cancer
Subgroup 4. Non-small cell lung cancer (NSCLC)
Subgroup 5. Cholangiocarcinoma
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.
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.
Adequate bone marrow reserves as assessed by the following hematology laboratory criteria:
Adequate major organ system function
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.
Patients may have undergone minor surgical procedures or limited-field radiotherapy provided any major organ toxicities have recovered to ≤ Grade 1.
Female patients must not be pregnant or breastfeeding.

Exclusion Criteria:

Patients with known active CNS metastases
Concurrent systemic steroid therapy
Any form of primary immunodeficiency
Patients who have decreased immune competence
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;
Any major bronchial occlusion or bleeding not amenable to palliation.
Patients with psychiatric illness/social situations at the time of treatment that would limit compliance with study requirements.
Participants with known active, uncontrolled bacterial, fungal, or viral infection
Patients with a prior history or concurrent malignancy
Active unstable or clinically significant medical condition
History of any major cardiovascular conditions within the past 6 months

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

180

Study ID:

NCT05194735

Recruitment Status:

Recruiting

Sponsor:

Alaunos Therapeutics

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There is 1 Location for this study

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MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Kim Ross
Contact
[email protected]
Scott Kopetz, MD, PhD
Principal Investigator
Marcelo Negrao, MD
Sub-Investigator

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

180

Study ID:

NCT05194735

Recruitment Status:

Recruiting

Sponsor:


Alaunos Therapeutics

How clear is this clinincal trial information?

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