SynKIR-110 for Mesothelin Expressing Ovarian Cancer, Cholangiocarcinoma or Mesothelioma
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| ClinicalTrials.gov Identifier: NCT05568680 |
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Recruitment Status :
Recruiting
First Posted : October 6, 2022
Last Update Posted : April 23, 2024
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Ovarian Cancer Cholangiocarcinoma Recurrent Mesothelioma, Malignant | Biological: SynKIR-110, Autologous T cells Transduced with Mesothelin KIR-CAR | Phase 1 |
This is a Phase 1, FIH, multicenter, open-label, dose-escalation pilot study of a single IV gravity drip infusion of SynKIR-110 in subjects with advanced, mesothelin-expressing tumors (ovarian cancer, primary peritoneal cancer, fallopian tube cancer, cholangiocarcinoma, or mesothelioma). Up to 42 subjects will be assessed to determine the safety and feasibility of treatment with SynKIR-110. Informed consent will be obtained from subjects prior to participation in this study.
The study includes an initial tumor biomarker screening, followed by an enrollment screening period (which includes pre-leukapheresis safety/eligibility and leukapheresis visits), treatment period (administration of non-myeloablative lymphodepleting chemotherapy followed by a single infusion of investigational product), and a 12-month follow-up period or until disease progression. Subjects will be followed for 12 months or until disease progression, at which point they will be invited to participate in a long-term safety follow-up study.
Up to 6 cohorts of 3 to 6 subjects per cohort will be assessed to determine the safety and feasibility of treatment with SynKIR-110. Doses will be escalated following a standard 3 + 3 design until either an MTD or MFD is reached. An additional 6 to 9 subjects will be enrolled at the MTD/MFD to further assess safety and potential activity of SynKIR-110.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 42 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 1 Study of SynKIR-110, Autologous T Cells Transduced With Mesothelin KIR-CAR, in Subjects With Mesothelin-Expressing Advanced Ovarian Cancer, Cholangiocarcinoma, or Mesothelioma |
| Actual Study Start Date : | March 30, 2023 |
| Estimated Primary Completion Date : | March 15, 2026 |
| Estimated Study Completion Date : | March 30, 2026 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: SynKIR-110
Single dose gravity drip IV administration
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Biological: SynKIR-110, Autologous T cells Transduced with Mesothelin KIR-CAR
Autologous T cells Transduced with Mesothelin KIR-CAR |
- Safety and feasibility of SynKIR-110 [ Time Frame: Date of enrollment through date of last patient visit, up to 36 months. ]• The incidence, frequency, and severity of TEAEs, incidence of AEs related to native mesothelin-expressing tissues, • Incidence of CRS and/or neurologic toxicity
- Define the MTD or MFD of SynKIR-110 [ Time Frame: Date of enrollment until the MTD is defined, up to 18 months ]Define the MTD or MFD of SynKIR-110
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Pathologically confirmed recurrent or relapsed advanced ovarian cancer, primary peritoneal cancer, fallopian tube cancer, cholangiocarcinoma, or epithelial mesothelioma (pleural or peritoneal) after at least 1 prior line of systemic therapy for advanced disease
- Adult 18 years of age or older.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- For ovarian cancer and mesothelioma, tumor expression of mesothelin ≥50% of tumor cells with ≥2+ staining intensity (on a scale of 0 to 3). For cholangiocarcinoma ≥10% of cells at any staining intensity (≥1+).
- Has at least 1 measurable lesion by iRECIST for ovarian cancer or cholangiocarcinoma or lesions measurable for mRECIST for mesothelioma.
- Satisfactory Blood coagulation parameters:
- Satisfactory organ and bone marrow function
Exclusion Criteria:
- Active invasive cancers other than mesothelioma, cholangiocarcinoma, and ovarian unless surgically and medically cured without evidence of recurrent disease for 5 years.
- History of T or B cell malignancies or previous gene-engineered T cell therapies.
- Sarcomatoid/biphasic mesothelioma.
- Pulmonary exclusions:
- Have acquired hereditary, congenital immunodeficiency or have recognized immunodeficiency disease
- Active hepatitis B, active hepatitis C, or any HIV infection at the time of screening
- Active autoimmune disease
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05568680
| Contact: Mala K Talekar, MBBS,DABP | 267.331.3800 | mala.talekar@verismotherapeutics.com | |
| Contact: Loretta Brozena, BSN, MBA | 267.392.6838 | loretta.brozena@verismotherapeutics.com |
| United States, Pennsylvania | |
| University of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Katie Elkins 215-615-6740 katie.elkins@pennmedicine.upenn.edu | |
| Principal Investigator: Janos Tanyi, MD, PhD | |
| United States, Texas | |
| MDAnderson | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Rachelle David, BSN,RN 281-684-5271 rsdavid@mdanderson.org | |
| Principal Investigator: Mehmet Altan, MD | |
| Study Director: | Mala K Talekar, MBBS,DABP | Verismo Therapeutics |
| Responsible Party: | Verismo Therapeutics |
| ClinicalTrials.gov Identifier: | NCT05568680 |
| Other Study ID Numbers: |
STAR-101 |
| First Posted: | October 6, 2022 Key Record Dates |
| Last Update Posted: | April 23, 2024 |
| Last Verified: | March 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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Ovarian Neoplasms Carcinoma, Ovarian Epithelial Cholangiocarcinoma Mesothelioma Mesothelioma, Malignant Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Genital Neoplasms, Female |
Urogenital Neoplasms Genital Diseases Endocrine System Diseases Gonadal Disorders Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Adenocarcinoma Adenoma Neoplasms, Mesothelial Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Pleural Neoplasms Lung Diseases |