Actively Recruiting
Treatment of Advanced or Metastatic Triple-negative Breast Cancer With Adoptive Therapy of PD1+ TILS
Led by Fundacio Clinic Barcelona · Updated on 2023-11-24
20
Participants Needed
4
Research Sites
271 weeks
Total Duration
On this page
Sponsors
F
Fundacio Clinic Barcelona
Lead Sponsor
S
SOLTI Breast Cancer Research Group
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a prospective, multicenter, phase I/II, open-label, two-stage design of PD1+ TILs infusion in metastatic or advanced TNBC. TILS001 includes 3 parts. Previous to each phase inclusion, a specific ICF must be signed by the patient. Participants potentially eligible to participate in the clinical trial will be offered to sign a ICF three times prior to TILs treatment: 1) to allow for collection of archival FFPE tissue samples for determination PD1 by mRNA (Part #1), 2) prior to a fresh metastatic biopsy for selection, isolation and partial expansion of PD1+ TILs (Part #2) and 3) prior to allow for remaining study procedures and TILs therapy (Part #3, Main Consent).
CONDITIONS
Official Title
Treatment of Advanced or Metastatic Triple-negative Breast Cancer With Adoptive Therapy of PD1+ TILS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Estimated life expectancy of 6 months or more
- Histologically confirmed unresectable or metastatic breast cancer
- Histologically confirmed advanced triple-negative breast cancer with HER2-negative, ER and PgR expressions less than 10%
- Up to 5 prior lines of standard chemotherapy for inoperable/metastatic disease
- No history of other malignancy within the past 3 years except certain treated non-melanoma skin cancers, cervical carcinoma in situ, breast ductal carcinoma in situ, prostatic intraepithelial neoplasia, or superficial bladder carcinoma
- Willingness and ability to comply with all study visits and procedures
- No psychiatric, substance abuse, sociological, or geographic issues affecting compliance
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- No pregnancy or breastfeeding
- No known sensitivity to study treatment components
- No immediate family members involved as study staff unless approved
- No prior allogeneic hematopoietic stem cell transplantation
- No symptomatic or active autoimmune disease requiring systemic treatment in past 2 years except vitiligo or resolved childhood asthma/atopy
- No active tuberculosis history
- No known history of HIV, Hepatitis B, or active Hepatitis C infection
- Ability to provide tumor tissue for gene expression analysis
- PD-1 mRNA expression above 20th percentile in tumor sample
- At least one resectable target lesion
- No measurable disease progression in brain
- Successful partial expansion of PD1+ TILs from tumor sample
- Treatment-related toxicities Grade 1 or lower except alopecia and neuropathy grade 2
- Measurable disease per RECIST 1.1
- Adequate organ function
- Negative pregnancy test if female of childbearing potential
- Normal cardiac function for patients 60 years or older or with cardiac history
- Not receiving other investigational treatments
- No systemic steroid therapy above 10 mg prednisone or equivalent except replacement therapy
- No clinically significant immunosuppression
- No current or steroid-requiring pneumonitis
You will not qualify if you...
- Pregnant or breastfeeding women
- History of other malignancy within past 3 years except specified treated conditions
- Presence of clinically active cerebral metastases or carcinomatous meningitis
- Treatment-related toxicities greater than Grade 1 except alopecia and neuropathy grade 2
- Current treatment with other investigational drugs or devices
- Systemic steroid therapy above allowed dose
- Evidence of clinically significant immunosuppression
- Evidence or history of pneumonitis requiring steroids or current pneumonitis
- Known sensitivity to any treatment components
- Prior allogeneic hematopoietic stem cell transplantation
- Active autoimmune diseases requiring systemic treatment in past 2 years except specified exceptions
- Active tuberculosis history
- Known history of HIV, Hepatitis B or active Hepatitis C infection
- Immediate family members involved as study staff without approved exception
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Hospital Universitari Vall d'Hebrón
Barcelona, Spain, 08035
Actively Recruiting
2
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Actively Recruiting
3
Hospital 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
4
Clínica universidad de Navarra
Pamplona, Spain, 31008
Actively Recruiting
Research Team
T
Tomás Pascual
CONTACT
L
Laura Angelats
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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