A Phase Ib Study to Evaluate Safety and Persistence of ex Vivo Expanded Universal Donor NK Cells in Combination With IL-2 and TGFbeta Receptor I Inhibitor Vactosertib in Patients With Locally Advanced/Metastatic Colorectal Cancer, Gastric/Esophageal Cancer, and Relapsed/Refractory Hematologic Malignancies NK CELLS PLUS VACTOSERTIB

What's the purpose of this trial?

The purpose of this study is to show that using two medicines (vactosertib and IL-2) with NK cells will be safe and will activate the donor NK cells. 

This trial is currently open and accepting patients.

What will happen during the trial?

The objective of this research is to demonstrate that natural killer (NK) cells from non-Human Leukocyte Antigen (HLA)-matched donors can be safely infused into colorectal cancer patients and patients with relapsed/refractory hematologic malignancies in combination with IL-2 and the oral transforming growth factor beta (TGFβ) receptor I inhibitor vactosertib to improve the persistence of donor NK cells.

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

  • Subjects must have one of the following:

    • Histologically confirmed locally advanced or metastatic colon or rectal adenocarcinoma
    • Histologically confirmed locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma
    • Relapsed or refractory hematologic malignancy
    • Acute myeloid leukemia with measurable residual disease (MRD) relapse
    • MRD relapse is defined as presence of ≥ 1 in 10-4 nucleated cells per European LeukemiaNet 2021 guidance [49]: (1) conversion of MRD negativity to MRD positivity, independent of the MRD technique, or (2) increase of MRD ≥1 log10 between any two positive samples measured in the same tissue (PB or BM) in patients with MRD-Low Level
    • Patients will be eligible if they have declined or are ineligible for standard treatment options and if there is no standard approach to curative therapy per NCCN guidelines. Patients with solid tumors must have had progression on at least one standard line of therapy.

    • Hematologic malignancies in the relapsed or refractory setting can include:

      • Acute myeloid leukemia
      • Myelodysplastic syndrome
      • Acute lymphoblastic leukemia
      • Chronic myeloid leukemia
      • Chronic lymphocytic leukemia
      • Non Hodgkin Lymphoma
      • Hodgkin Lymphoma
      • Myeloproliferative syndromes
      • Plasma cell myeloma
  • Subjects must have recovered from acute toxicities of prior chemotherapy or stem cell transplant. Any prior non-hematologic vital organ toxicity (cardiac, pulmonary, hepatic, renal) of previous therapy must have resolved to grade 1 or less. Exceptions: Alopecia; subjects with chemotherapy-induced sensory neuropathy must have grade ≤ 3
  • Age ≥18 years. Because no dosing or adverse event data are currently available on the use of NK cells in subjects ≤18 years of age, children are excluded from this study.
  • Eastern Cooperative Oncology Group (ECOG) Performance status ≤2

  • Subjects must have normal organ and marrow function as defined below:

    • Serum total bilirubin <2 mg/dl. If known Gilbert syndrome, total bilirubin must be <3mg/dl
    • Aspartate aminotransferase (AST) < 2.5 X institutional upper limit of normal
    • Alanine Aminotransferase (ALT) < 2.5 X institutional upper limit of normal
    • Pulmonary function (DLCO) >40% of the expected value corrected for alveolar volume and hemoglobin
    • Serum Creatinine ≤ 1.5 X institutional upper limit of normal
    • Hemoglobin ≥ 7.5 g/dL
    • Absolute neutrophil count ≥ 1,250/mcL for colorectal cancer (CRC) patients or ≥ 1,000/mcL for patients with hematologic malignancies unless patient has bone marrow involvement of hematological malignancy
    • Platelet count ≥ 50,000/mcL; unless patient has bone marrow involvement of hematological malignancy
    • For patients with bone marrow involvement of hematologic malignancy, transfusion of blood products may be used to meet hemoglobin and platelet thresholds
  • Women of child-bearing potential and men must agree to use adequate contraception (double barrier method of birth control or abstinence) 4 weeks prior to study entry and for the duration of study participation. Women of child-bearing potential must have documented negative pregnancy test prior to start of lymphodepleting regimen. Child-bearing potential is defined by institutional standard.
  • Subjects must have the ability to understand and the willingness to sign a written informed consent document.
  • Subjects must have at least 3 weeks between last cytotoxic anti-neoplastic medication and initiation of preparative regimen.

Additional Trial Information

Phase 1

Enrollment: 12 patients (estimated)

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Trial Locations

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Ohio

Case Comprehensive Cancer Center Case Western Reserve University

Cleveland, OH

Open and Accepting
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