Actively Recruiting
KK-LC-1 TCR-T Cell Therapy for Gastric, Breast, Cervical, and Lung Cancer
Led by Christian Hinrichs · Updated on 2025-03-30
30
Participants Needed
2
Research Sites
326 weeks
Total Duration
On this page
Sponsors
C
Christian Hinrichs
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a phase I clinical trial to determine the maximum tolerated dose (MTD) of KK-LC-1 TCR-T cells for the treatment of metastatic cancers that express KK-LC-1. Participants will receive a conditioning regimen, KK-LC-1 TCR-T cells, and aldesleukin. The safety profile and clinical response to treatment will be determined.
CONDITIONS
Official Title
KK-LC-1 TCR-T Cell Therapy for Gastric, Breast, Cervical, and Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed, written informed consent before any study procedures
- Age over 18 years at consent
- Metastatic solid tumor with 10% or more tumor cells positive for KK-LC-1 by IHC assay
- Presence of HLA-A*01:01 allele confirmed by haplotype test
- Measurable disease according to RECIST Version 1.1
- Prior treatment with standard systemic cancer therapy for the cancer type, with documented rationale if unsuitable
- Fewer than 3 brain metastases treated by surgery or stereotactic radiosurgery and stable for at least one month
- ECOG performance status 0 or 1 at screening
- Negative pregnancy test for women under 55 or those who had a menstrual period in last 12 months; not required if bilateral oophorectomy or hysterectomy
- Women of child-bearing potential agree to use effective contraception prior to and for 12 months after treatment
- Adequate organ and marrow function including leukocytes > 3,000/mcL, neutrophils > 1,500/mcL, platelets > 100,000/mcL, hemoglobin > 9.0 g/dL
- Total bilirubin within normal limits (or <3.0 mg/dL if Gilbert's Syndrome)
- Serum AST/ALT less than 2.5 times upper limit of normal
- Creatinine clearance > 50 mL/min/1.73 m2 if creatinine elevated
- INR or PTT ≤ 1.5 times upper limit of normal unless on anticoagulant therapy with therapeutic range and no severe hemorrhage
- Negative HIV antibody, Hepatitis B antigen, and Hepatitis C antibody or RNA (no current infection)
- At least 4 weeks since prior systemic therapy with resolution of adverse events to grade 1 or clinical stability
- Oxygen saturation ≥ 92% on room air
- Left ventricular ejection fraction ≥ 45% for patients 50 years or older
You will not qualify if you...
- Current treatment with another investigational agent
- History of severe allergic reactions to similar compounds used in this study
- Uncontrolled illness such as active infection, symptomatic heart failure, unstable angina, arrhythmia, or psychiatric/social conditions limiting compliance
- Breastfeeding if the mother is treated with KK-LC-1 TCR cells or other study agents due to unknown risks
- Systemic immunodeficiency including HIV or primary immunodeficiency
- Use of immunosuppressive drugs including corticosteroids unless allowed by protocol
- HLA-A*01:01 damaging mutation, allele loss, or molecular resistance detected
- Severe autoimmune diseases like Crohn's disease, ulcerative colitis, rheumatoid arthritis, autoimmune hepatitis, pancreatitis, or lupus
- Prior or concurrent malignancy likely to interfere with safety or efficacy assessments, except certain low-risk cancers
- Receipt of a live vaccine within 30 days prior to enrollment
- Investigator determination that participation is not in the subject's best interest or may jeopardize safety or data integrity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
2
RWJBarnabas Health - Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
Research Team
T
Tobi Adewale
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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