Actively Recruiting
Biological Tumor Infiltrating Lymphocytes Therapy With Immunotherapy for Colon and Rectum Cancer
Led by Essen Biotech · Updated on 2024-11-05
85
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This Phase I/II study evaluates the safety and efficacy of autologous tumor-infiltrating lymphocytes (TIL) therapy combined with Pembrolizumab (Keytruda) and Aldesleukin (interleukin-2, IL-2) immunotherapy in patients with advanced or metastatic refractory colon and rectal cancer (colorectum). TILs will be harvested from patients' tumors, expanded in vitro, and infused back into the patients following a non-myeloablative lymphodepletion regimen. Pembrolizumab, a monoclonal antibody targeting the PD-1 receptor on T cells, will be administered to enhance the immune response, while Aldesleukin will be used to further stimulate the TILs. The primary endpoint is to determine the objective response rate (ORR) of this combined therapy. Secondary endpoints include disease control rate (DCR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), and quality of life (QoL). This trial aims to provide a novel, personalized treatment option for patients with limited therapeutic alternatives.
CONDITIONS
Official Title
Biological Tumor Infiltrating Lymphocytes Therapy With Immunotherapy for Colon and Rectum Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 16 and 90 years
- Histologically confirmed primary, relapsed, or metastatic colon or rectal cancer
- Expected life expectancy longer than 3 months
- Karnofsky performance status ≥60% or ECOG score 0-2
- Failed standard cancer treatments or no standard treatments available
- Presence of tumor areas suitable for biopsy or resection, or malignant fluid for TIL isolation
- At least one tumor lesion that can be evaluated
- Blood counts within specified limits: white blood cells ≥2.5×10^9/L, neutrophils ≥1.5×10^9/L, lymphocytes ≥0.7×10^9/L, platelets ≥100×10^9/L, hemoglobin ≥90 g/L
- Coagulation tests within limits unless recent anticoagulant use
- Kidney and liver function tests within specified limits
- No contraindications to surgery or biopsy
- Women of child-bearing potential agree to use effective contraception during and for 1 year after lymphodepletion
- No cancer-targeting therapies within 28 days before TIL collection
- Able to understand and sign informed consent
- Able to follow study visit and requirements
You will not qualify if you...
- Need for glucocorticoid treatment with prednisone dose >15 mg/day or immunomodulatory treatment for autoimmune diseases
- Lung function impairment: FEV1 <2L or DLCO <40%
- Significant heart problems including NYHA Class III/IV heart failure, low blood pressure, severe coronary artery disease, ejection fraction <35%, or severe arrhythmias
- Active infections including HIV, HBV, HCV, syphilis
- Severe physical or mental illness
- Active systemic infection requiring treatment or positive blood cultures
- Receiving other medications or therapies including chemotherapy, radiotherapy, biologics within the past month
- History of allergy to cell therapy-like substances
- Previous immune therapy with severe immune-related adverse events above Level 3
- Unresolved side effects from prior anti-tumor treatments above grade 1 (except alopecia)
- Pregnant or breastfeeding women
- History of organ or stem cell transplant or kidney replacement therapy
- Other severe systemic diseases or clinical conditions judged inappropriate for the study
AI-Screening
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Trial Site Locations
Total: 1 location
1
District One Hospital
Beijing, Beijing Municipality, China, 086-373
Actively Recruiting
Research Team
R
Rhoda M Smith, Phd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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