Status:
RECRUITING
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
Lead Sponsor:
A2 Biotherapeutics Inc.
Collaborating Sponsors:
Tempus AI
Conditions:
Solid Tumor, Adult
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The goal of this study is to test autologous logic-gated Tmod™ CAR T-cell products in subjects with solid tumors including colorectal cancer (CRC), pancreatic cancer (PANC), non-small cell lung cancer...
Detailed Description
This is a seamless phase 1/2, multi-center, open-label study that enrolls adults with recurrent unresectable, locally advanced, or metastatic (considered non-curative) CRC, NSCLC, PANC, OVCA, MESO or ...
Eligibility Criteria
Inclusion
- Key
- 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
- Key
Exclusion
- Has disease that is suitable for local therapy or able to receive standard of care therapy that is therapeutic and not palliative
- Prior allogeneic stem cell transplant
- Prior solid organ transplant
- 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
- History of interstitial lung disease including drug-induced interstitial lung disease and radiation pneumonitis that requires treatment with prolonged steroids or other immune suppressive agents within 1 year
- Requires supplemental home oxygen
- Females of childbearing potential who are pregnant or breastfeeding
- Subjects, both male and female, of childbearing potential who are not willing to practice birth control from the time of consent through 6 months post infusion
Key Trial Info
Start Date :
April 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2029
Estimated Enrollment :
474 Patients enrolled
Trial Details
Trial ID
NCT06051695
Start Date
April 3 2024
End Date
June 1 2029
Last Update
December 12 2025
Active Locations (12)
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1
Banner Health
Gilbert, Arizona, United States, 85234
2
UCSD Moores Cancer Center
La Jolla, California, United States, 92093
3
UCLA Medical Center
Los Angeles, California, United States, 90404
4
Stanford University
Stanford, California, United States, 94305