RecruitingPhase 1

Phase I Trial of Vididencel in CML-CP Patients With MRD Under TKI Treatment

Norway24 participantsStarted 2026-04-14

Plain-language 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). 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 effectiveform of contraception (with Pearl index \< 1%) throughout the study and for at least 3 months after the last dose of study medication.…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

assess safety and tolerability of vididencel in CML-CP participants with MRD unable to meet TFR under TKI treatment

Timeframe: through 30 days after the last dose of vididencel.

Trial details

NCT IDNCT07651878

SponsorMendus

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-09-01

Contact for this trial

annelies Legters, MSC

+31681100447 annelies.legters@mendus.com

View on ClinicalTrials.gov More CML (Chronic Myelogenous Leukemia) trials