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Could a cell shot free CML patients from daily pills?
NCT ID NCT07651878
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tests a cell therapy called vididencel in 24 adults with chronic myeloid leukemia (CML) who still have traces of cancer despite taking standard medication. The goal is to see if adding vididencel to their current treatment is safe and might eventually allow them to lower or stop their daily pills. Participants receive injections over several months and are followed for up to 3 years.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- vididencel (a cell therapy made from donor cells)
- What this could lead to
- If it works, this could help some CML patients reduce or stop their daily TKI medication without the cancer returning.
- What could go wrong
- This is a very early Phase 1 trial with only 24 participants, so it may not work or could have side effects. Participants may not benefit directly.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Mar 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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. 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Haukeland University Hospital
RECRUITINGBergen, Norway
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