Colorectal CancerPhase 1NCT05400122
Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer
A Phase 1 study testing Vactosertib, Fludarabine Phosphate and Cyclophosphamide in people with Colorectal Cancer and Hematologic Malignancy, run by David Wald at 1 site in United States.
Trial summary
One of the ways that cancer grows and spreads is by avoiding the immune system.NK cells are immune cells that kill cancer cells, but are often malfunctioning in people with colorectal cancer and blood cancers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Hematologic Malignancy, Rectum Cancer
- What is being tested?
- Vactosertib, Fludarabine Phosphate and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2022to 1 Jun 2027
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- Subjects receiving any other investigational agents
- Subjects requiring systemic corticosteroid therapy (10mg or less of prednisone or equivalent doses of other systemic steroids are permitted).
- Subjects for whom a potential 29-day delay in treatment will interfere with their potential therapeutic options
- Patients with active, untreated malignant involvement of the central nervous system (CNS) should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. If clinical suspicion for CNS involvement, head imaging will be necessary to document absence of active CNS involvement in patients with colorectal or esophagogastric cancer. Patients with hematologic malignancies who have undergone treatment for malignant involvement of the CNS must have no clinical evidence of residual CNS disease prior to study enrollment.
- History of allergic reactions to fludarabine or cyclophosphamide
- Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
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- Pregnant or breastfeeding women are excluded from this study because cytotoxic agents used as part of the lymphodepleting regimen have the potential for teratogenic or abortifacient effects. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with lymphodepleting chemotherapy, breastfeeding should be discontinued if the mother participates in the trial. These potential risks may also apply to other agents used in this study.
- HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with chemotherapeutic agents. In addition, these patients are at increased risk of lethal infections when treated with marrow suppressive therapy.
- Chronic active untreated hepatitis B or C infection. (Assessments should include Hepatitis B Surface Ab, Hepatitis B Surface Ag, Hepatitis B Core Ab - Total, Hepatitis B Core Ab, IGM, Hepatitis C Ab).
- Recipients of previous allogeneic transplants who have rash involving more than 10% body surface area attributed to graft versus host disease (GVHD). Stem cell transplant recipients will be excluded if they are still receiving immunosuppression including steroids for GVHD or have active GVHD in any organ (except for 10% BSA of skin, not requiring treatment).
- Subject who is taking prohibited medications when using vactosertib as following (refer to APPENDIX III). A minimal washout period of 5 half-lives for the following drugs is recommended prior to the first dosing.
- Concurrent use of drugs or foods that are known strong CYP3A4 inhibitors including but not limited to grapefruit juice, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, voriconazole. The topical use of these medications (if applicable), such as 2% ketoconazole cream, may be allowed.
- Concurrent use of drugs that are known potent CYP3A4 inducers including but not limited to phenytoin, rifampin, St. John's wort.
- Concurrent use of drugs that are CYP3A4, CYP1A2, CYP2B6 substrates with narrow therapeutic indices including but not limited to theophylline, astemizole, cisapride, cyclosporine, dihydroergotamine, ergotamine, sirolimus, tacrolimus, terfenadine (astemizole, cisapride, and terfenadine have been withdrawn from the US market).
- Concurrent use of drugs that are sensitive CYP3A4, CYP1A2, CYP2B6 substrates including but not limited to efavirenz, darunavir, dasatinib, everolimus, lopinavir, midazolam, sirolimus, ticagrelor.
- QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 12-lead ECGs
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
About this study
Official title: 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
One of the ways that cancer grows and spreads is by avoiding the immune system.NK cells are immune cells that kill cancer cells, but are often malfunctioning in people with colorectal cancer and blood cancers. A safe way to give people with colorectal cancer and blood cancers fresh NK cells from a healthy donor has recently been discovered. 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. NK cells and vactosertib are experimental because they are not approved by the Food and Drug Administration (FDA). IL-2 (Proleukin®) has been approved by the FDA for treating other cancers, but the doses used in this study are lower than the approved doses and it is not approved to treat colorectal cancer or blood cancers.
Read the detailed description
The goal of our study is to demonstrate that natural killer (NK) cells from non- HLA-matched donors can be safely infused into patients with colorectal cancer, patients with gastric or esophageal cancer, and patients with relapsed/refractory hematologic malignancies in combination with IL-2 and the oral TGFβ receptor I inhibitor vactosertib to improve the persistence of donor NK cells.
- Conditions
- Colorectal Cancer, Hematologic Malignancy, Rectum Cancer, Acute Myeloid Leukemia, Myelodysplastic Syndromes, Acute Lymphoblastic Leukemia
- Being tested
- Vactosertib, Fludarabine Phosphate, Cyclophosphamide, IL-2, Natural Killer Cells
- Medical subject headings
- Colorectal Neoplasms, Hematologic Neoplasms, Rectal Neoplasms, Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VactosertibDrug
Also called TEW-7197, EW-7197, EW7197
Vactosertib is a highly selective, potent inhibitor of the protein serine/threonine kinase activity of transforming growth factor (TGF)-β receptor type 1 (TGFBR1; also known as activin receptor-like kinase 5 [ALK5]). Vactosertib inhibits the phosphorylation of the ALK5 substrates Smad2 and Smad3, as well as the intracellular signaling of TGF-β.
Also called Fludara
Fludarabine phosphate is rapidly dephosphorylated to 2-fluoro-ara-A and then phosphorylated intracellularly by deoxycytidine kinase to the active triphosphate, 2-fluoroara-ATP. This metabolite appears to act by inhibiting DNA polymerase alpha, ribonucleotide reductase and DNA primase, thus inhibiting DNA synthesis.
CyclophosphamideDrug
Also called Cytoxan, 2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate
Cyclophosphamide is an alkylating agent that prevents cell division by cross-linking DNA strands and decreasing DNA synthesis. It is a cell cycle phase nonspecific agent. Cyclophosphamide also possesses potent immunosuppressive activity.
IL-2Drug
Also called Proleukin
Proleukin® (aldesleukin) has been shown to possess the biological activities of human native interleukin-2. In vitro studies performed on human cell lines demonstrate the immunoregulatory properties of Proleukin, including: a) enhancement of lymphocyte mitogenesis and stimulation of long-term growth of human interleukin-2 dependent cell lines; b) enhancement of lymphocyte cytotoxicity; c) induction of killer cell (lymphokine-activated (LAK) and natural (NK)) activity; and d) induction of interferon-gamma production.
The in vivo administration of Proleukin in animals and humans produces multiple immunological effects in a dose dependent manner. These effects include activation of cellular immunity with profound lymphocytosis, eosinophilia, and thrombocytopenia, and the production of cytokines including tumor necrosis factor, IL-1 and gamma interferon. In vivo experiments in murine tumor models have shown inhibition of tumor growth
Natural Killer CellsDrug
Adoptive NK cell therapy has demonstrated the potential for cancer immunotherapy in various malignancies with particular potential in hematologic malignancies including acute myeloid leukemia (AML), and colon cancer [14, 19-23]. This therapeutic approach is extremely well tolerated in patients even when massive numbers of cells are utilized (~109 NK cells/kg). In fact, studies suggest that high doses of NK cells are not only well tolerated but have potential to lead to higher levels of efficacy.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Infusion | Experimental | Preparative Regimen Administration:
* Fludarabine will be given at a dose of 30mg/m2 intravenously daily
* Cyclophosphamide will be given at a dose of 500mg/m2 intravenously daily
Investigational Agent Administration:
* NK Cell Product will be given per institutional standard of care (at a rate no faster than 250mL per hour or 3-4 ml per minute) as two doses by intravenous infusion on Days 0 (+2 days acceptable) and 14 (+/- 3 days acceptable)
* IL-2 will be administered at a flat dose of 2.2 million IU subcutaneously starting on the same day as the first NK cell infusion and will be administered three times weekly (dose level 1) or twice weekly (dose level -1) for up to four weeks total
* Vactosertib will be administered at a dose of 200mg once daily for 5 consecutive days per week, for up to four weeks total. Receives: Drug: Vactosertib; Drug: Fludarabine Phosphate; Drug: Cyclophosphamide; Drug: IL-2; Drug: Natural Killer Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])
This will be defined as the incidence of Grade ≥ 2 treatment-related adverse events
Measured: Within 28 days of NK cell infusion
Persistence of donor NK cells
This will be defined as the presence of donor NK cells in recipient blood as determined by next-generation sequencing-chimerism at a frequency of >10%.
Measured: 7 days post-treatment
Secondary outcomes (4)
Persistence of donor NK cells
This will be defined as the presence of donor NK cells in recipient blood as determined by next-generation sequencing-chimerism at a frequency of >10%.
Measured: 14 days post-treatment
Persistence of donor NK cells
This will be defined as the presence of donor NK cells in recipient blood as determined by next-generation sequencing-chimerism at a frequency of >10%.
Measured: 21 days post-treatment
Persistence of donor NK cells
This will be defined as the presence of donor NK cells in recipient blood as determined by next-generation sequencing-chimerism at a frequency of >10%.
Measured: 28 days post-treatment
Clinical Response
This will be defined as a change in size of measurable disease on CT scans (colorectal cancer) or by standard methods for hematologic malignancies (e.g. bone marrow biopsy for AML)
Measured: 28 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start9 Sep 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Why it stopped: Drugs unavailable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Approximately 12 subjects will be enrolled in this trial and all will receive a preparative regimen consisting of lymphodepleting chemotherapy agents followed by two infusions of ex vivo-expanded NK cells in combination with vactosertib and IL-2 (Proleukin®).
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- David Wald
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, David Wald, Case Comprehensive Cancer Center
- Investigators
- Benjamin Tomlinson, MD, Principal investigator, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05400122
- Sponsor's protocol ID
- CASE6Y21
- Status last verified
- Jun 2026
- First submitted
- 27 May 2022
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05400122
- Acronym / sponsor ID
- CASE6Y21
- Conditions
- Colorectal Cancer, Hematologic Malignancy, Rectum Cancer, Acute Myeloid Leukemia, Myelodysplastic Syndromes, Acute Lymphoblastic Leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Drugs unavailable
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- David WaldUniversity, hospital or other
- Study start
- 9 Sep 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 1 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
One of the ways that cancer grows and spreads is by avoiding the immune system.NK cells are immune cells that kill cancer cells, but are often malfunctioning in people with colorectal cancer and blood cancers. A safe way to give people with colorectal cancer and blood cancers fresh NK cells from a healthy donor has recently been discovered. 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. NK cells and vactosertib are experimental because they are not approved by the Food and Drug Administration (FDA). IL-2 (Proleukin®) has been approved by the FDA for treating other cancers, but the doses used in this study are lower than the approved doses and it is not approved to treat colorectal cancer or blood cancers.
Detailed description
The goal of our study is to demonstrate that natural killer (NK) cells from non- HLA-matched donors can be safely infused into patients with colorectal cancer, patients with gastric or esophageal cancer, and patients with relapsed/refractory hematologic malignancies in combination with IL-2 and the oral TGFβ receptor I inhibitor vactosertib to improve the persistence of donor NK cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Approximately 12 subjects will be enrolled in this trial and all will receive a preparative regimen consisting of lymphodepleting chemotherapy agents followed by two infusions of ex vivo-expanded NK cells in combination with vactosertib and IL-2 (Proleukin®).
| Arm | Type | Receives |
|---|---|---|
| Experimental Infusion | Experimental | Drug: Vactosertib, Drug: Fludarabine Phosphate, Drug: Cyclophosphamide, Drug: IL-2, Drug: Natural Killer CellsPreparative Regimen Administration: * Fludarabine will be given at a dose of 30mg/m2 intravenously daily * Cyclophosphamide will be given at a dose of 500mg/m2 intravenously daily Investigational Agent Administration: * NK Cell Product will be given per institutional standard of care (at a rate no faster than 250mL per hour or 3-4 ml per minute) as two doses by intravenous infusion on Days 0 (+2 days acceptable) and 14 (+/- 3 days acceptable) * IL-2 will be administered at a flat dose of 2.2 million IU subcutaneously starting on the same day as the first NK cell infusion and will be administered three times weekly (dose level 1) or twice weekly (dose level -1) for up to four weeks total * Vactosertib will be administered at a dose of 200mg once daily for 5 consecutive days per week, for up to four weeks total. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (33 listed)
- Subjects must have one of the following:
- 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:
Key exclusion criteria (16 listed)
- Subjects receiving any other investigational agents
- Subjects requiring systemic corticosteroid therapy (10mg or less of prednisone or equivalent doses of other systemic steroids are permitted).
- Subjects for whom a potential 29-day delay in treatment will interfere with their potential therapeutic options
- Patients with active, untreated malignant involvement of the central nervous system (CNS) should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. If clinical suspicion for CNS involvement, head imaging will be necessary to document absence of active CNS involvement in patients with colorectal or esophagogastric cancer. Patients with hematologic malignancies who have undergone treatment for malignant involvement of the CNS must have no clinical evidence of residual CNS disease prior to study enrollment.
- History of allergic reactions to fludarabine or cyclophosphamide
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VactosertibAlso: TEW-7197, EW-7197, EW7197Vactosertib is a highly selective, potent inhibitor of the protein serine/threonine kinase activity of transforming growth factor (TGF)-β receptor type 1 (TGFBR1; also known as activin receptor-like kinase 5 [ALK5]). Vactosertib inhibits the phosphorylation of the ALK5 substrates Smad2 and Smad3, as well as the intracellular signaling of TGF-β. | Drug | Experimental Infusion |
| Fludarabine PhosphateAlso: FludaraFludarabine phosphate is rapidly dephosphorylated to 2-fluoro-ara-A and then phosphorylated intracellularly by deoxycytidine kinase to the active triphosphate, 2-fluoroara-ATP. This metabolite appears to act by inhibiting DNA polymerase alpha, ribonucleotide reductase and DNA primase, thus inhibiting DNA synthesis. | Drug | Experimental Infusion |
| CyclophosphamideAlso: Cytoxan, 2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrateCyclophosphamide is an alkylating agent that prevents cell division by cross-linking DNA strands and decreasing DNA synthesis. It is a cell cycle phase nonspecific agent. Cyclophosphamide also possesses potent immunosuppressive activity. | Drug | Experimental Infusion |
| IL-2Also: ProleukinProleukin® (aldesleukin) has been shown to possess the biological activities of human native interleukin-2. In vitro studies performed on human cell lines demonstrate the immunoregulatory properties of Proleukin, including: a) enhancement of lymphocyte mitogenesis and stimulation of long-term growth of human interleukin-2 dependent cell lines; b) enhancement of lymphocyte cytotoxicity; c) induction of killer cell (lymphokine-activated (LAK) and natural (NK)) activity; and d) induction of interferon-gamma production. The in vivo administration of Proleukin in animals and humans produces multiple immunological effects in a dose dependent manner. These effects include activation of cellular immunity with profound lymphocytosis, eosinophilia, and thrombocytopenia, and the production of cytokines including tumor necrosis factor, IL-1 and gamma interferon. In vivo experiments in murine tumor models have shown inhibition of tumor growth | Drug | Experimental Infusion |
| Natural Killer CellsAdoptive NK cell therapy has demonstrated the potential for cancer immunotherapy in various malignancies with particular potential in hematologic malignancies including acute myeloid leukemia (AML), and colon cancer [14, 19-23]. This therapeutic approach is extremely well tolerated in patients even when massive numbers of cells are utilized (~109 NK cells/kg). In fact, studies suggest that high doses of NK cells are not only well tolerated but have potential to lead to higher levels of efficacy. | Drug | Experimental Infusion |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])
Time frame: Within 28 days of NK cell infusion
This will be defined as the incidence of Grade ≥ 2 treatment-related adverse events
Persistence of donor NK cells
Time frame: 7 days post-treatment
This will be defined as the presence of donor NK cells in recipient blood as determined by next-generation sequencing-chimerism at a frequency of >10%.
4 secondary outcomes
Persistence of donor NK cells
Time frame: 14 days post-treatment
Persistence of donor NK cells
Time frame: 21 days post-treatment
Persistence of donor NK cells
Time frame: 28 days post-treatment
Clinical Response
Time frame: 28 days post-treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Tomlinson, MD principal investigator
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vactosertib, Fludarabine Phosphate and Cyclophosphamide in people with Colorectal Cancer and Hematologic Malignancy, run by David Wald at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 33 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) (time frame: Within 28 days of NK cell infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.