Actively Recruiting
A First-In-Human Trial of pTTL in Advanced Colorectal Cancer
Led by Neogap Therapeutics AB · Updated on 2025-05-29
16
Participants Needed
2
Research Sites
480 weeks
Total Duration
On this page
Sponsors
N
Neogap Therapeutics AB
Lead Sponsor
C
CTC Clinical Trial Consultants AB
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is an open-label, non-randomised FIH trial investigating the safety and tolerability of a novel ATMP, pTTL, composed of autologous tumour-draining lymph node-derived T cells stimulated in vitro with personalised cancer neoantigens. The neoantigens are selected through a process starting with next generation sequencing (NGS) of tumour material from the patient followed by selection of neoantigenic mutations using an in-house software, PIOR®. Selected neoantigen epitopes are expressed as recombinant proteins, NAG, and used to stimulate T cells to promote neoantigen-specific T cell expansion in vitro in pTTL production. pTTL is thus based on autologous cells stimulated with patient-specific neoantigens. In consequence, every pTTL product is unique and designated for use in one single individual. pTTL will be administered to patients with stage IV colorectal cancer (CRC) as a single intravenous dose.
CONDITIONS
Official Title
A First-In-Human Trial of pTTL in Advanced Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Adult aged 18 years or older
- Histological or cytological confirmation of colorectal cancer
- Stage IV metastatic disease with prior standard therapies completed, or further standard treatments not considered best option, or treatment pause as judged by investigator
- Measurable disease according to RECIST1.1
- Life expectancy of at least 6 months at primary inclusion and 3 months at pTTL administration
- ECOG performance status 0 to 1
- Adequate blood counts and organ function including hemoglobin, neutrophils, platelets, liver enzymes, bilirubin, creatinine, and albumin
- Willingness to use effective birth control during treatment and for 6 months after pTTL if of childbearing potential or partner is
- Ability to undergo surgery or biopsy to obtain tumor tissue and regional lymph nodes for pTTL production
- Area for lymph node collection has not been exposed to radiotherapy
You will not qualify if you...
- Clinically significant cardiovascular event within 4 months before primary inclusion and 6 months before pTTL administration (except well-controlled atrial fibrillation)
- New York Heart Association class III or IV congestive heart failure
- Significantly reduced lung function with clinical implications or recent severe lung infections
- Severe acute or chronic medical conditions increasing risk or interfering with trial results
- Immunodeficiency disorders posing risk or affecting treatment outcome (excluding HIV)
- Autoimmune disorders posing risk or affecting treatment outcome
- Leptomeningeal metastases or active brain metastases with recent progression or symptoms
- Ongoing systemic immunosuppressive medication (with some steroid exceptions)
- Previous severe immune-related toxicity from immunotherapy unless resolved and rechallenged without recurrence
- Acute or chronic infections with hepatitis B or C, syphilis, or HIV
- Pregnant or breastfeeding
- Unlikely to comply with trial procedures
- Less than 3 identifiable enlarged lymph nodes accessible for surgery
- Previous surgical removal of primary colorectal tumor posing high surgical risk
- Unable to withstand planned surgery including anaesthesia
- Less than 4 weeks since stopping systemic cancer treatment
- Less than 2 weeks since stopping radiotherapy
- Less than 4 weeks after major surgery or less than 3 weeks after minor surgery
- Participation in another cancer therapy trial or investigational drug treatment within 4 weeks
- Less than 4 weeks since receiving live attenuated vaccines
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Medical Unit Cell therapy and Allogeneic Stem cell Transplantation (ME CAST), and the Center for Clinical Cancer studies - Phase 1 unit, Karolinska University Hospital
Stockholm, Stockholm County, Sweden, 17176
Actively Recruiting
2
Unit for Colorectal Surgery, Dept. of Surgery, Västmanlands Sjukhus Västerås
Västerås, Västerås, Sweden, 723 35
Actively Recruiting
Research Team
S
Samuel Svensson, PhD
CONTACT
A
Andrea Salmén, MSE
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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