PTCy + Sirolimus/VIC-1911 as GVHD Prophylaxis in Myeloablative PBSC Transplantation

NCT05120570 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: 2021LS006MT2021-01
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm, phase I/II, study of PTCy/sirolimus plus VIC-1911 to prevent GVHD and relapse after Allogeneic Hematopoietic Cell Transplantation (alloHCT).

Conditions

Acute Leukemia; Myelodysplastic Syndromes; Myeloproliferative Neoplasm; Lymphoma

Keywords

VIC-1911; PTCy; Myeloablative; Allogeneic

Outcome Measures

Primary Outcomes (3)

• Determine the Optimal Dose of VIC-1911 When Given in Combination With Standard Immunosuppressive Therapy in Adult Patients Undergoing Myeloablative Stem Cell Transplantation.

  The optimal dose will be identified using the EffTox design. The proportion of patients with an average CD4+, pH3ser10+ T cell of \<54%. The minimum desired biologic efficacy is 65% of patients by day 21 (+/- 3 days) with \<30% of patients experiencing a DLT. Data only to reported from arm with maximum tolerated dose.

  21 days post treatment

• Progression-free Survival

  Participant progression-free survival assessed using aGVHD data.

  1 Year

• Relapsed Assessment (Phase I)

  Assessment to determine if patient has relapse in MTD arm. Data only to reported from arm with maximum tolerated dose.

  12 months

Secondary Outcomes (6)

• Overall Survival (OS)

  1 year

• To Determine the Cumulative Incidences of Acute GVHD

  Day 100

• To Determine the Cumulative Incidences of Chronic GVHD

  12 months

• Progression-free Survival Comparing Graft-Versus-Host Disease-Free (GRFS) to the Standard PTCY Plus Tacrolimus/Mycophenolate Mofetil Regimen From MT2015-29

  12 months

• Progression Free Survival

  1 Year

Study Arms (1)

PTCy/sirolimus plus VIC-1911

EXPERIMENTAL

Patients enrolled and treated with PTCy/sirolimus plus VIC-1911

Drug: VIC- 1911

Interventions

VIC- 1911 DRUG

25 mg, 50 mg, or 75 mg administered twice a day from day 5 post HCT to day 45, and the dose escalation will stop once we identify the lowest biologically active and safe dose of VIC.

PTCy/sirolimus plus VIC-1911

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

Study Sites (1)

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

• Holtan SG, Grover P, Walton K, El Jurdi N, Quinones V, Maakaron JE, Juckett MB, Bachanova V, Hou JH, Terezakis S, Myers TJ, Paradiso LJ, DeFor TE, Cao Q, Betts BC. Targeting Aurora kinase A to prevent GVHD and relapse after myeloablative allogeneic hematopoietic cell transplantation. Blood Adv. 2026 Apr 14;10(7):2190-2201. doi: 10.1182/bloodadvances.2025017360.

  PMID: 41592279 DERIVED

MeSH Terms

Conditions

Myelodysplastic Syndromes; Myeloproliferative Disorders; Lymphoma

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Punita Grover, MBBS
• Organization: Masonic Cancer Center

groverp@umn.edu

(612) 273-8383

Study Officials

• Sherman Holtan, MD

  Masonic Cancer Center, University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: November 15, 2021
• Study Start: March 17, 2022
• Primary Completion: September 19, 2024
• Study Completion: June 30, 2025
• Last Updated: December 22, 2025
• Results First Posted: December 22, 2025

Record last verified: 2025-12

Locations

US (1)