Status:
ACTIVE_NOT_RECRUITING
Phase I Study of Autologous CD8+ and CD4+ Engineered T Cell Receptor T Cells in Subjects With Advanced or Metastatic Solid Tumor
Lead Sponsor:
Affini-T Therapeutics, Inc.
Conditions:
Pancreatic Ductal Adenocarcinoma
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This study is open to adult patients with solid tumors who have a KRAS G12V mutation. This mutation is often found in non-small cell lung cancer (NSCLC), colorectal cancer (CRC), pancreatic ductal ade...
Detailed Description
AFNT-211 is a cellular therapy consisting of autologous CD4+ and CD8+ T cells engineered to express a human leukocyte antigen-A (HLA-A)\*11:01-restricted Kirsten rat sarcoma (KRAS) G12V-specific trans...
Eligibility Criteria
Inclusion
- Key
- Confirmed KRAS G12V mutational status and HLA-A\*11:01 allele
- Histologically confirmed advanced or metastatic, unresectable solid tumor
- Progressed on or intolerant of at least one prior line of standard systemic therapy for the current malignancy.
- Measurable disease per RECIST v1.1.
- ECOG performance status 0-1
- Adequate organ and bone marrow function
- Key
Exclusion
- Any systemic cytotoxic chemotherapy, investigational agents, or any anti-tumor drug from a previous treatment regimen or clinical study (including small molecules and I/O compounds) within 5 half-lives or 14 days of Screening, whichever is shorter.
- Any prior gene therapy utilizing an integrating vector
- Previous allogeneic stem cell transplantation or prior organ transplantation
- History of treated primary immunodeficiency, autoimmune, or inflammatory disease including inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, myasthenia gravis, or Grave's disease
- Primary brain tumor
- Untreated central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression.
- Uncontrolled active bacterial, viral, fungal, or mycobacterial infection
- Pregnant or lactating subjects
- Surgery or catheter-based interventions
- Previously identified allergy, hypersensitivity, or known contraindication to cyclophosphamide, fludarabine, or any other agent associated with lymphodepleting chemotherapy (LDC) or AFNT-211 product
- Uncontrolled significant intercurrent or recent illness
- Diagnosis of another malignancy within 2 years prior to screening.
- Seropositive for hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb)
- Seropositive for hepatitis C antibody.
- Known human immunodeficiency virus (HIV) infection
Key Trial Info
Start Date :
March 6 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06105021
Start Date
March 6 2024
End Date
December 1 2029
Last Update
July 30 2025
Active Locations (10)
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1
USC Norris Comprehensive
Los Angeles, California, United States, 90033
2
University of California Los Angeles Department of Medicine
Los Angeles, California, United States, 90095
3
Yale New Haven Hospital
New Haven, Connecticut, United States, 06511
4
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, United States, 10016