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New treatment option for CML (Chronic Myelogenous Leukemia)
Official title Phase I Trial of Vididencel in CML-CP Patients With MRD Under TKI Treatment
ClinicalTrials.gov ID: NCT07651878
What this study is testing
What is vididencel?
vididencel is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for cml (chronic myelogenous leukemia).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Time commitment: about 6 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- MRD positive meaning BCR::ABL1 \ 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...
You likely can't join if
- Participants who are scheduled for allogeneic stem cell transplantation (allo HSCT) or participants who have undergone allo HSCT less than 5 years...
- 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).
See the full eligibility 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 \ 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...
- 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...
- 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
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Bergen, Norway
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bergen, Norway. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.