New combo therapy aims to tame stem cell transplant complications
NCT ID NCT05120570
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new drug called VIC-1911 added to standard medications to prevent graft-versus-host disease (GVHD) in 16 adults with blood cancers receiving a stem cell transplant. The goal was to find a safe and effective dose that reduces GVHD and relapse. Results are still being analyzed.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- VIC-1911
- What this could lead to
- If successful, this could lead to a safer stem cell transplant with less risk of graft-versus-host disease and relapse.
- What could go wrong
- This is an early-phase trial with only 16 participants, so results may not apply broadly. The drug may cause side effects or not work as hoped.
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
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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16 people
The number who actually took part.
- Started
-
Mar 2022
- Finished
-
Jun 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
-
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: * Diagnosis of * acute leukemia in complete remission, or * myelodysplasia with \<5% blasts, or * myeloproliferative neoplasm/myelofibrosis with \<5% marrow or circulating blasts * chemosensitive Hodgkin or non-Hodgkin lymphoma * Age 18 years or older * Performance status of ≥ 80% Karnofsky * Adequate organ function within 28 days of study registration defined as: * left ventricular ejection fraction ≥ 45% * pulmonary function with FEV1, FVC, and DLCO ≥ 50% predicted * AST and ALT \< 2 times upper limit of normal * Total bilirubin \<1.5 times the upper limit of normal. If the patient is suspected of having Gilbert syndrome, they require prior approval of the medical monitor * creatinine clearance ≥ 50cc/min * no active/uncontrolled infection * negative HIV, HBV and HCV * ferritin \< 2000 ng/ml * Patients able to tolerate oral medication * Women of childbearing potential and men with partners of child-bearing potential must agree to use of contraception for the duration of treatment through 60 days after the last treatment of VIC-1911 or sirolimus * Able to provide written voluntary consent prior to the performance of any research related tests or procedures Exclusion Criteria: * HCT-CI \> 4 or unable to receive myeloablative TBI * Use of planned post-transplant maintenance therapy to begin prior to day +75. Patients may receive standard of care maintenance therapies starting at day +75 or later * Patients with a history of hypersensitivity to any of the investigational products * Pregnant or breastfeeding as agents used in this study are Pregnancy Category o C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations, and Pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. Females of childbearing potential must have a negative pregnancy test (serum or urine) within 28 days of study registration. * Women or men of childbearing potential unwilling to take adequate precautions to avoid unintended pregnancy from the start of protocol treatment through 60 days after the last treatment of VIC-1911 or sirolimus
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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.
Contacts and locations
Locations
-
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, 55455, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Double-Drug attack on Hard-to-Treat lymphomas
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- PET scans guide Nivolumab-Chemo combo in relapsed hodgkin lymphoma
- Patient's own t cells engineered to hunt lymphoma in early trial
- Tweaking donor cells may shield older transplant patients from a dangerous complication