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Phase I/II study of QEL-001 in A2-mismatch liver transplant patients
EU CTIS ID: 2024-516193-30-01
What this study is testing
To evaluate the safety and tolerability of a single target dose of QEL-001
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participants (regardless of gender) must be 18 to 75 years of age inclusive, at the time of signing the informed consent.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
- Being on stable maintenance of immunosuppression for at least 12 weeks prior to study entry
- HLA A2/A28neg (including split antigens A68neg and A69neg) participants who have received an A2pos liver transplant.
- Having received a liver transplant 12 months to 5 years prior to study entry with: a. No episodes of rejection in the previous 12 months (except early rejection taking place in the first 3 months post-transplantation. b. No previous episodes of rejection requiring lymphodepleting antibody therapy.
- Having alanine aminotransferase (ALT) <60 U/L and either alkaline phosphatase (ALP) <200 U/L or gamma-glutamyl transferase (GGT) <100 U/L
You likely can't join if
- Having any medical condition that, in the opinion of the principal investigator (PI), would interfere with safe completion of the trial including: a. Severe cardiac disease, severe respiratory disease with O2 blood saturation <92%. b. Any other major organ dysfunction.
- Having triglycerides ≥ 3.95 mmol/L (350 mg/dL) despite appropriate therapy
- Having cholesterol ≥ 7.8 mmol/L (301.5 mg/dL) despite appropriate therapy
- Having QTc > 450 msec for male participants or QTc > 470 msec for female participants or QTc > 480 msec in participants with bundle branch block
- Having any contraindications to receive rATG, EVR (notably participants with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption), TAC or rituximab
- Receiving any other concurrent investigational agents within 3 months prior study entry
See the full eligibility criteria
Who can join
- Participants (regardless of gender) must be 18 to 75 years of age inclusive, at the time of signing the informed consent.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
- Being on stable maintenance of immunosuppression for at least 12 weeks prior to study entry
- HLA A2/A28neg (including split antigens A68neg and A69neg) participants who have received an A2pos liver transplant.
- Having received a liver transplant 12 months to 5 years prior to study entry with: a. No episodes of rejection in the previous 12 months (except early rejection taking place in the first 3 months post-transplantation. b. No previous episodes of rejection requiring lymphodepleting antibody therapy.
- Having alanine aminotransferase (ALT) <60 U/L and either alkaline phosphatase (ALP) <200 U/L or gamma-glutamyl transferase (GGT) <100 U/L
- Having eGFR ≥ 40 mL/min/1.73 m2 using the MDRD formula
- Having an adequate bone marrow (BM) function without requiring ongoing blood product(s) or granulocyte colony-stimulating factor (GCSF) and meeting the following criteria: a. Absolute neutrophil count ≥ 1.0 x 10e9/L b. Absolute lymphocyte count ≥ 0.3 x 10e9/L c. Leucocyte count ≥ 2.0 x 10e9/ L d. Haemoglobin ≥ 80 g/L e. Platelet greater or equal to 100 x 10e9/L
- Having an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Able and willing to use a highly effective method of contraception (male participants and female participants with reproductive potential) from informed consent through and for at least 12 months
- A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) at Screening, prior to conditioning with rATG and prior/post QEL-001 infusion
What rules you out
- Having any medical condition that, in the opinion of the principal investigator (PI), would interfere with safe completion of the trial including: a. Severe cardiac disease, severe respiratory disease with O2 blood saturation <92%. b. Any other major organ dysfunction.
- Having triglycerides ≥ 3.95 mmol/L (350 mg/dL) despite appropriate therapy
- Having cholesterol ≥ 7.8 mmol/L (301.5 mg/dL) despite appropriate therapy
- Having QTc > 450 msec for male participants or QTc > 470 msec for female participants or QTc > 480 msec in participants with bundle branch block
- Having any contraindications to receive rATG, EVR (notably participants with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption), TAC or rituximab
- Receiving any other concurrent investigational agents within 3 months prior study entry
- Having an active infection as defined in the study protocol
- Having previous history of human immunodeficiency virus (HIV)
- Evidence of active or latent tuberculosis (TB). After anti-TB treatment, patients with history of active or latent TB may become eligible according to national guidelines
- Recent history of reactivation of Cytomegalovirus (CMV) defined as positive DNA test within 6 months prior entry to the study
- Females who are pregnant (i.e., positive blood or urine β human Chorionic Gonadotropin (β- hCG) test) or lactating
- Having received prior non-liver solid organ or hematopoietic stem cell transplant.
- Do not have: a. up-to-date vaccination status as per local immunization schedules/national guidelines (e.g., influenza and pneumococcal vaccination for >65 years old). b. any required vaccination (if required) at least 2 weeks prior to study entry, in accordance with national guidelines
- Have known or suspected hypersensitivity or allergy to DMSO present in QEL-001 as excipients
- Having a non-adequate bilateral venous access for leukapheresis, or not willing to undergo a central venous catheter insertion
- Having contraindications to undergo a leukapheresis
- Have any significant medical or social condition that, in the Investigator's opinion, may interfere with the participant's optimal participation or compliance with the study procedure
- Having history of liver cirrhosis or advanced fibrosis post-transplantation
- Receiving prohibited medications that cannot be stopped at study entry
- Have had any major surgical intervention in the last 3 months prior to study entry (such as open surgeries requiring general anaesthetic)
- History of autoimmune disease requiring systemic immunosuppression, systemic disease modifying agents or biologics within the last 24 months prior to study entry
- History of autoimmune hepatitis, primary sclerosing cholangitis or primary biliary cholangitis
- Having any evidence of recurrent hepatocellular carcinoma (HCC) following clinical assessment; for participants with liver explant histology showing a RETREAT score greater than 0 the clinical assessment should include a thoraco-abdominal radiological scan (CT or MRI according to local clinical practice) performed within 1 month prior to enrolment
- History of HCC with high risk of recurrence defined as: a. For participants who are <2 years post-transplant: a) RETREAT score greater than or equal to 3. b. For participants who are 2-5 years post-transplant: a) RETREAT score greater than or equal to 4. c. Additional explant-based exclusion criteria: i) presence of diffuse HCC in explant; ii) presence of extrahepatic extension or macrovascular invasion; iii) diagnostics of cholangiocarcinoma; iv) pariticipants who have undergone a downstaging procedure pretransplantation
- Having active primary or recurrent malignant disease or have been in remission from clinically significant malignancy for less than 5 years. a. Except participants that have had a cervical carcinoma in situ that has been resected with no evidence of recurrence or metastatic disease for at least 3 years may participate in the study. b. Except participants that have had basal cell or squamous epithelial skin cancers that have been completely resected with no evidence of recurrence for at least 3 years may participate in the study
- Having urine protein to creatinine ratio > 25mg/mmol or > 50mg/mmol if the participant is already under dual therapy TAC/EVR
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom. 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 EU CTIS; the study team decides eligibility.