OncoMatch/Clinical Trials/NCT07651878
Phase I Trial of Vididencel in CML-CP Patients With MRD Under TKI Treatment
Is NCT07651878 recruiting? Yes, currently enrolling (Jul 2026). This Phase 1 trial studies vididencel for cml (chronic myelogenous leukemia).
Treatment: vididencel — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Chronic Myeloid Leukemia
Biomarker criteria
Required: BCR bcr::abl1 expression 0.01% < x < 10% is, stable over 6 months (0.01% < x < 10% IS, stable over 6 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.
Disease stage
Required: Stage CHRONIC PHASE (other)
chronic phase (CP) (according to ELN 2025)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: tyrosine kinase inhibitor — chronic phase CML
treated with the same TKI for minimum 24 months
Cannot have received: allogeneic stem cell transplantation
Exception: allowed if >5 years ago and no sign of graft-versus-host disease
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.
Lab requirements
Liver function
AST and ALT ≤ 3 x upper limit of normal (ULN), serum bilirubin ≤ 3 x ULN
Inadequate liver function (AST and ALT > 3 x upper limit of normal (ULN), serum bilirubin >3 x ULN) [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07651878 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior allogeneic stem cell transplantation disqualifies patients from enrollment.
Does this trial require BCR?
Yes, BCR bcr::abl1 expression 0.01% < x < 10% is, stable over 6 months is a required biomarker for enrollment.
What disease stage is eligible?
Stage CHRONIC PHASE is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages