Clinical trial Recruiting at 1 site Phase 1 Interventional Ages 18 and up

Vididencel in CML-CP Patients with MRD

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

Run by Mendus · NCT07651878 · Data updated 2026-11-12

This study tests whether the cell therapy vididencel can be given safely to adults with chronic myeloid leukemia in chronic phase who still have measurable residual disease despite long-term TKI therapy.

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment24 (estimated)
SponsorMendus
Industry-sponsored
Drugs / interventionsprednisone
Locations1 site (Bergen)
StatusRecruiting
StartedApril 14, 2026
Main results expectedSeptember 1, 2029
Study endsMarch 1, 2030
Registry record updatedNovember 6, 2026
Trial IDNCT07651878 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (≥18) with Ph+ CML in chronic phase who have been on the same TKI for at least 24 months and have stable MRD (BCR-ABL1 0.01% IS to <10%), ECOG 0-1, and willing to comply with study procedures.

Probably not a fit

Participants may not experience any direct medical benefit and could experience treatment-related risks from the cell therapy.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 interventional trial evaluates the safety and potential side effects of vididencel in adults with Philadelphia-positive CML in chronic phase who remain MRD-positive after at least 24 months on a single TKI. Participants receive a course of low-volume intradermal vididencel injections over roughly 5 months, followed by extended safety follow-up for up to 3 years. The study monitors adverse events and tolerability, with no guaranteed direct clinical benefit expected for participants. Key eligibility requires stable MRD levels and continuation on the same TKI for the prior 24 months. Enrollment is conducted at a site in Bergen, Norway, under Mendus as lead sponsor, with collaborative support from TFS HealthScience and Clinfidence B.V.

Why it matters

Potential benefit: If successful, vididencel could offer a new treatment option for patients with MRD who wish to stay on TKI therapy while exploring additional disease control.

How similar studies have gone: Earlier similar cell-therapy approaches in CML or MRD settings have shown safety signals but conclusive efficacy remains to be established; this study explores safety in a well-defined MRD-positive population.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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.
* 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

Exclusion Criteria:

\- 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.
* 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

Where it's running

  • Haukeland University Hospital
    Bergen, Norway
    Recruiting

Study contacts

  • Principal investigator: Bjorn Torre Gjertsen, MD,PhD, Professor Hematology — Haukeland University Hospital, Bergen, Noorwegen
  • Study coordinator: annelies Legters, MSC
  • Email: annelies.legters@mendus.com
  • Phone: +31681100447

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.