A Study to Evaluate the Safety and Efficacy of Mesothelin-Targeting Logic-gated CAR T, in Partici… (NCT06051695) | Clinical Trial Compass
RecruitingPhase 1/2
A Study to Evaluate the Safety and Efficacy of Mesothelin-Targeting Logic-gated CAR T, in Participants With Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression
United States474 participantsStarted 2024-04-03
Plain-language summary
The goal of this study is to test autologous logic-gated Tmodâ„¢ CAR T-cell products in subjects with solid tumors including colorectal cancer (CRC), pancreatic cancer (PANC), non-small cell lung cancer (NSCLC), ovarian cancer (OVCA), mesothelioma (MESO), and other solid tumors that express mesothelin (MSLN) and have lost HLA-A\*02 expression.
The main questions this study aims to answer are:
Phase 1: What is the recommended dose that is safe for patients
Phase 2: Does the recommended dose kill solid tumor cells and protect the patient's healthy cells
Participants will be required to perform study procedures and assessments, and will also receive the following study treatments:
Enrollment and Apheresis in BASECAMP-1 (NCT04981119)
Preconditioning Lymphodepletion (PCLD) Regimen
Tmod CAR T cells at the assigned dose
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Appropriately enrolled in the BASECAMP-1 A2 Biotherapeutics, Inc. study, with tissue demonstrating LOH of HLA-A\*02 by NGS (whenever possible from the primary site), successful apheresis and PBMC processing, and with sufficient stored cells available for Tmod CAR T-cell therapy
✓. Histologically confirmed recurrent unresectable, locally advanced, or metastatic CRC, NSCLC, PANC, OVCA, MESO, or other solid tumors with MSLN expression. Measurable disease is required with lesions of ≥1.0 cm by CT.
✓. Received previous required therapy for the appropriate solid tumor disease as described in the protocol
✓. Has adequate organ function as described in the protocol
✓. ECOG performance status of 0 to 1
✓. Life expectancy of ≥3 months
✓. Willing to comply with study schedule of assessments including long term safety follow up
Exclusion criteria
✕. Has disease that is suitable for local therapy or able to receive standard of care therapy that is therapeutic and not palliative
What they're measuring
1
Phase 1: Rate of adverse events and dose limiting toxicities (DLTs) by dose level
Timeframe: From the time of Informed consent until 24 months (2 years) post infusion
2
Phase 1: Recommended Phase 2 Dose (RP2D)
Timeframe: 21 days post infusion
3
Phase 2: The Overall Response Rate (ORR) for patients
✕. MESO with pleural involvement extending into the peritoneum
✕. Cancer therapy within 3 weeks or 3 half lives of infusion
✕. Radiotherapy within 28 days of infusion
✕. Unstable angina, arrhythmia, myocardial infarction, or any other significant cardiac disease within the last 6 months
✕. Any new symptomatic pulmonary embolism (PE) or a deep vein thrombosis (DVT) within 3 months of enrollment. Therapeutic dosing of anticoagulants is allowed for history of PE or DVT if greater than 3 months from time of enrollment, and adequately treated