CML (Chronic Myelogenous Leukemia)Phase 1NCT07651878
Vididencel in CML-CP Patients With MRD
A Phase 1 study testing vididencel in people with CML (Chronic Myelogenous Leukemia), run by Mendus at 1 site in Norway.
Trial summary
The main purpose of the trial is to evaluate the safety and potential side effects of cell therapy vididencel in Chronic Myeloid Leukemia (CML) participants with measurable residual disease (MRD) unable to stop treatment with tyrosine kinase inhibitor (TKI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CML (Chronic Myelogenous Leukemia)
- What is being tested?
- vididencel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteNorway
- Study dates
- 14 Apr 2026to 1 Mar 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged ≥ 18 years at the time of informed consent.
- Signed and dated informed consent document indicating that the participant has been informed of all the pertinent aspects of the trial prior to any study-related activities.
- Willing to comply with clinical trial instructions and requirements.
- Confirmed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP) (according to ELN 2025) treated with the same TKI for minimum 24 months.
- MRD positive meaning BCR::ABL1 <10% - >0.01% IS at a stable level over the last 6 months. A value must not increase to ≥ 3 fold from baseline or a value must not decrease to ≤ 1/3 fold from baseline. All three measurements must fall within a 3-fold range, i.e., the ratio between the highest and lowest of the three values must be <3.
- Adequate performance status: Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
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- Expected co-operation of participant regarding treatment and follow-up procedures according to the treating physician.
- Women of childbearing potential (WOCBP) defined as all women physiologically capable of becoming pregnant, must present a negative serum pregnancy test result within 3 days prior to first dosing and a negative urine pregnancy test on the day of first dosing. Additionally, they must use a highly effective form of contraception (with Pearl index < 1%) throughout the study and for at least 3 months after the last dose of study medication.
- Men with partners of childbearing potential must be willing to use condoms during intercourse while on study and should not father a child in this period. A condom is required to be used also by vasectomized men
Who cannot join
- Participants who are scheduled for allogeneic stem cell transplantation (allo HSCT) or participants who have undergone allo HSCT less than 5 years ago.
- Participants who have undergone allo HSCT more than 5 years ago and had any sign of graft-versus-host disease.
- Uncontrolled or serious infections.
- Ongoing systemic immunosuppressive therapy, other than short use of low dose steroids, i.e. equivalent to an average dose of ≤10 mg of prednisone/day.
- Use of any other experimental drug or therapy within 28 days or 5 half-lives of the investigational drug, whichever is longer of baseline.
- Active autoimmune disease or participants with recent history, except for well controlled diabetes and stable thyroid disease.
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- Inadequate liver function (AST and ALT > 3 x upper limit of normal (ULN), serum bilirubin >3 x ULN).
- Other active malignancies within the last 5 years, except for adequately treated carcinoma in situ of the cervix or non-melanoma carcinoma of the skin.
- Pregnant or lactating females.
- Major surgical procedure (including open biopsy) within 28 days prior to the first study treatment, or anticipation of the need for major surgery during the course of the study treatment.
- Evidence of any other medical conditions (such as psychiatric illness, physical examination or laboratory findings) that may interfere with the planned treatment, affect participant compliance or place the participant at high risk from treatment-related complications.
- Known HIV, Hepatitis B and/or Hepatitis C infections.
- Known hypersensitivity to vididencel, or any of the ingredients or excipient in the formulation.
- Participants who, in the opinion of the Investigator, would clinically benefit from switching to an alternative TKI therapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Haukeland University Hospital
Bergen
Bjorn Torre Gjertsen, MD,PhD, +47 41566248, Bjorn.Gjertsen@uib.no
About this study
Official title: An Open-Label, Single-Arm Phase 1 Trial to Evaluate the Safety, Tolerability and Efficacy of Vididencel in Chronic Phase Chronic Myeloid Leukemia Patients With Measurable Residual Disease Unable to Meet Requirements of Treatment Free Remission Under Tyrosine Kinase Inhibitor Treatment
The main purpose of the trial is to evaluate the safety and potential side effects of cell therapy vididencel in Chronic Myeloid Leukemia (CML) participants with measurable residual disease (MRD) unable to stop treatment with tyrosine kinase inhibitor (TKI). Patients may not receive any direct medical benefit from participating. Participants in the study should have been treated with TKI for at least 24 months prior to enrolment. This TKI must be of the same type throughout the 24 months. Participation in the active period of the study will take about 5 months after which patients will be followed with regular checks for a total of 3 years from the study start. The cell therapy is administered as 2 low-volume intradermal injections.The first 4 treatments will be performed once every two weeks over a period of 6 weeks. Further treatments are given 14 and 18 weeks after the start of participation as 1 low-volume intradermal injection.The belief is that addition of the study treatment (vididencel) to tyrosine kinase inhibitor therapy may potentially strengthen the immune defence so that enough leukemic cells are killed that the TKI treatment can eventually be decreased in dose or even stopped permanently, without the CML progressing again.
- Conditions
- CML (Chronic Myelogenous Leukemia)
- Being tested
- vididencel
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vididencelBiological
4 intradermal injections of 1 ml containing 25e6 cells + 2 injection of 0,4 ml containing 10e6 cells
| Study group | Role | What they receive |
|---|---|---|
| vididencel treatment arm | Experimental | Not described Receives: Biological: vididencel |
What is being measured
The primary outcome is the main question the study is designed to answer.
assess safety and tolerability of vididencel in CML-CP participants with MRD unable to meet TFR under TKI treatment
Incidence, severity, and causality of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) through 30 days after the last dose of vididencel.
Number of dose interruptions and treatment discontinuations due to adverse events (AEs).
Measured: through 30 days after the last dose of vididencel.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start14 Apr 2026
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CML (Chronic Myelogenous Leukemia)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mendus
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- TFS HealthScience, Clinfidence B.V.
- Responsible party
- Sponsor
- Investigators
- Tariq Mughal, MD FRCP FRCPath, Study director, Mendus BVBjorn Torre Gjertsen, MD,PhD, Professor Hematology, Principal investigator, Haukeland University Hospital, Bergen, Noorwegen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07651878
- Sponsor's protocol ID
- VITAL-CML
- Other IDs
- 2025-524587-37-00, 2025
- Status last verified
- Nov 2026
- First submitted
- 11 Jun 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Arm Phase 1 Trial to Evaluate the Safety, Tolerability and Efficacy of Vididencel in Chronic Phase Chronic Myeloid Leukemia Patients With Measurable Residual Disease Unable to Meet Requirements of Treatment Free Remission Under Tyrosine Kinase Inhibitor Treatment
- ClinicalTrials.gov ID
- NCT07651878
- Acronym / sponsor ID
- VITAL-CML
- Conditions
- CML (Chronic Myelogenous Leukemia)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- MendusIndustry (pharma, biotech, devices)
- Collaborators
- TFS HealthScience, Clinfidence B.V.
- Study start
- 14 Apr 2026 (actual)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 1 Mar 2030 (estimated)
- First posted
- 16 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of the trial is to evaluate the safety and potential side effects of cell therapy vididencel in Chronic Myeloid Leukemia (CML) participants with measurable residual disease (MRD) unable to stop treatment with tyrosine kinase inhibitor (TKI). Patients may not receive any direct medical benefit from participating. Participants in the study should have been treated with TKI for at least 24 months prior to enrolment. This TKI must be of the same type throughout the 24 months. Participation in the active period of the study will take about 5 months after which patients will be followed with regular checks for a total of 3 years from the study start. The cell therapy is administered as 2 low-volume intradermal injections.The first 4 treatments will be performed once every two weeks over a period of 6 weeks. Further treatments are given 14 and 18 weeks after the start of participation as 1 low-volume intradermal injection.The belief is that addition of the study treatment (vididencel) to tyrosine kinase inhibitor therapy may potentially strengthen the immune defence so that enough leukemic cells are killed that the TKI treatment can eventually be decreased in dose or even stopped permanently, without the CML progressing again.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vididencel treatment arm | Experimental | Biological: vididencel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female aged ≥ 18 years at the time of informed consent.
- Signed and dated informed consent document indicating that the participant has been informed of all the pertinent aspects of the trial prior to any study-related activities.
- Willing to comply with clinical trial instructions and requirements.
- Confirmed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP) (according to ELN 2025) treated with the same TKI for minimum 24 months.
- MRD positive meaning BCR::ABL1 <10% - >0.01% IS at a stable level over the last 6 months. A value must not increase to ≥ 3 fold from baseline or a value must not decrease to ≤ 1/3 fold from baseline. All three measurements must fall within a 3-fold range, i.e., the ratio between the highest and lowest of the three values must be <3.
Key exclusion criteria (14 listed)
- Participants who are scheduled for allogeneic stem cell transplantation (allo HSCT) or participants who have undergone allo HSCT less than 5 years ago.
- Participants who have undergone allo HSCT more than 5 years ago and had any sign of graft-versus-host disease.
- Uncontrolled or serious infections.
- Ongoing systemic immunosuppressive therapy, other than short use of low dose steroids, i.e. equivalent to an average dose of ≤10 mg of prednisone/day.
- Use of any other experimental drug or therapy within 28 days or 5 half-lives of the investigational drug, whichever is longer of baseline.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vididencel4 intradermal injections of 1 ml containing 25e6 cells + 2 injection of 0,4 ml containing 10e6 cells | Biological | vididencel treatment arm |
Primary outcome
assess safety and tolerability of vididencel in CML-CP participants with MRD unable to meet TFR under TKI treatment
Time frame: through 30 days after the last dose of vididencel.
Incidence, severity, and causality of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) through 30 days after the last dose of vididencel. Number of dose interruptions and treatment discontinuations due to adverse events (AEs).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tariq Mughal, MD FRCP FRCPath study director
Mendus BV
Bjorn Torre Gjertsen, MD,PhD, Professor Hematology principal investigator
Haukeland University Hospital, Bergen, Noorwegen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing vididencel in people with CML (Chronic Myelogenous Leukemia), run by Mendus at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact annelies Legters, MSC (+31681100447, annelies.legters@mendus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assess safety and tolerability of vididencel in CML-CP participants with MRD unable to meet TFR under TKI treatment (time frame: through 30 days after the last dose of vididencel.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.