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New treatment option for Colorectal Cancer
Official title A First-In-Human Trial of pTTL in Advanced Colorectal Cancer
ClinicalTrials.gov ID: NCT05908643
What this study is testing
What is pTTL?
pTTL is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for colorectal cancer.
Also referred to as personal tumour-trained lymphocytes.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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®.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Signed informed consent.
- Adult (age ≥18 years).
- Histological or cytological confirmation of CRC.
- Verified metastatic disease (stage IV classification) and have received all possible standard of care therapies, OR further standard of care...
- Measurable disease according to RECIST1.1.
You likely can't join if
- Less than 4 months at primary inclusion and 6 months at pTTL administration since a clinically significant cardiovascular event such as myocardial...
- Congestive heart failure New York Heart Association (NYHA)class III or IV.
- Significantly reduced lung function with clinical implications. If such is suspected, spirometry should be performed. Spirometry should also be...
- Any severe acute or chronic medical condition that places the patient at increased risk or interferes with the interpretationof trial results (as...
- Immunodeficiency disorders which may pose a risk for patients treated with pTTL, and/or affect the outcome of the pTTL treatment, as judged by...
- Autoimmunity disorders which may pose a risk for patients treated with pTTL, and/or affect the outcome of the pTTL treatment, as judged by...
See the full eligibility criteria
Who can join
- Signed informed consent.
- Adult (age ≥18 years).
- Histological or cytological confirmation of CRC.
- Verified metastatic disease (stage IV classification) and have received all possible standard of care therapies, OR further standard of care therapies are currently not considered to be in the patient's best interest...
- Measurable disease according to RECIST1.1.
- Minimum life expectancy of 6 months at primary inclusion and 3 months at pTTL administration.
- Minimum life expectancy of 3 months from the time that the individual pTTL DP is estimated to be available (as per Investigators clinical assessment). 7. ECOG performance status 0 to 1
- Adequate hematopoietic, hepatic and renal function defined as:
- Haemoglobin≥ 95 g/L (blood transfusion not less than 21 days prior to screening),
- Absolute neutrophil count ≥ 1.0x 109/L, platelets ≥100 x 109/L
- Total bilirubin \< 1.5 x ULN (does not apply to patients with Gilberts Syndrome)
- AST and ALT ≤ 1.5 x ULN (or ≤ 5 x ULN in the presence of liver metastases)
- Serum creatinine ≤ ULN (if serum creatinine is between 1 and 1.5 x ULN, patients may be eligible provided that the calculated GFR is at least 35 mL/min using Cockcroft- Gault method).
- Albumin ≥24 g/L
- Patients of childbearing potential or their partners of childbearing potential must be willing to take the appropriate precaution to avoid pregnancy or fathering a child for the duration of Part I and Part II and...
- Combined (oestrogen and progesterone containing) hormonal birth control associated with inhibition of ovulation: oral, intravaginal, transdermal
- Progesterone-only hormonal birth control associated with inhibition ofovulation: oral, injectable, implantable
- Intrauterine device (IUD)or intrauterine hormone-releasing system (IUS) Bilateral tubal occlusion
- Vasectomised partner
- True sexual abstinence when this is in line with the preferred and usuallifestyle of the patient. Periodic abstinence (e.g., calendar ovulation,symptothermal, post-ovulation methods) is not acceptable
- Able to undergo surgery or biopsy to obtain tumour tissue for neoantigen evaluation and to retrieve RLNs as starting material for pTTL manufacturing
- The area from which the RLNs will be obtained shall not have been exposed to radiotherapy.
What rules you out
- Less than 4 months at primary inclusion and 6 months at pTTL administration since a clinically significant cardiovascular event such as myocardial infarction, unstable angina, angioplasty, bypass surgery, stroke or...
- Congestive heart failure New York Heart Association (NYHA)class III or IV.
- Significantly reduced lung function with clinical implications. If such is suspected, spirometry should be performed. Spirometry should also be considered in patients who have been hospitalised due to Covid-19 infection...
- Any severe acute or chronic medical condition that places the patient at increased risk or interferes with the interpretationof trial results (as judged by the Principal Investigators, in agreement with Sponsor's...
- Immunodeficiency disorders which may pose a risk for patients treated with pTTL, and/or affect the outcome of the pTTL treatment, as judged by Investigator at the Treatment Site and/or the Investigator at the...
- Autoimmunity disorders which may pose a risk for patients treated with pTTL, and/or affect the outcome of the pTTL treatment, as judged by Investigator at the Treatment Site and/or the Investigator at the Recruitment...
- Leptomeningeal metastases (patient with previously treated brain metastases are eligible if there is no evidence of disease progression for a minimum of 8 weeks prior to inclusion
- in these cases a CNS MRI is required within the screening period. These patients must not have symptoms from their brain metastases or treatment thereof and must not be taking steroid medications for treatment of CNS...
- Patients are not allowed to have ongoing systemic immunosuppressive concomitant medications. Systemic immunosuppressive treatments should be completed 2 weeks prior to surgery and/or 2 weeks prior to dose. Steroid...
- Previous Grade 3 or greater immune-related toxicity from checkpoint modulation or other immunotherapy (unless the toxicity has resolved and the patient rechallenged with the therapy without recurrence of toxicity, in...
- Acute or chronic infection with hepatitis B or C or syphilis.
- HIV infection.
- Pregnancy or breast-feeding.
- Investigator considers the patient unlikely to comply with trial procedures, restrictions and requirements.
- For patients required to undergo trial-specific surgery to obtain starting material:
- Less than 3 identifiable enlarged lymph nodes on pre-surgery radiology accessible for surgical excision.
- Previous surgical removal of the primary CRC tumour (would entail a high risk surgery)
- Unable to withstand the planned surgery (including ineligibility for general anaesthesia) At decision to proceed to pTTL administration:
- Less than 4 weeks since stopping previous systemic cancer treatment.
- Less than 2 weeks since stopping radiotherapy.
- Less than 4 weeks after major surgery and less than 3 weeks after minor surgery.
- Participation in any other clinical cancer therapy trial, and planned treatment or treatment with another investigational drug, within the previous 4 weeks.
- Less than 4 weeks since administration of live attenuated vaccines.
The study team makes the final eligibility decision.
Where it's taking place
- Stockholm, Stockholm County, Sweden
- Västerås, Västerås, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stockholm, Stockholm County, Sweden; Västerås, Västerås, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.