MedTrace Logo

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

NCT07651878 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-06-16

No results posted yet for this study

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.

Conditions

  • CML (Chronic Myelogenous Leukemia)

Interventions

BIOLOGICAL

vididencel

4 intradermal injections of 1 ml containing 25e6 cells + 2 injection of 0,4 ml containing 10e6 cells

Sponsors & Collaborators

  • TFS HealthScience

    collaborator UNKNOWN

  • Clinfidence B.V.

    collaborator UNKNOWN

  • Mendus

    lead INDUSTRY

Principal Investigators

  • Tariq Mughal, MD FRCP FRCPath · Mendus BV

  • Bjorn Torre Gjertsen, MD,PhD, Professor Hematology · Haukeland University Hospital, Bergen, Noorwegen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-14
Primary Completion
2029-09-01
Completion
2030-03-01

Countries

  • Norway

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07651878 on ClinicalTrials.gov