Recruiting
Phase 1
Phase 2

UD TGFbetai NK Cells & Temozolomide

Sponsor:

Kari Kendra

Code:

NCT05588453

Conditions

Clinical Stage IV Cutaneous Melanoma AJCC v8

Metastatic Malignant Neoplasm in the Brain

Metastatic Melanoma

Pathologic Stage IV Cutaneous Melanoma AJCC v8

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Natural Killer Cell Therapy

Temozolomide

Study Details

Brief summary:

This phase I/II trial tests the safety, side effects, and best dose of universal donor UD TGFbetai natural killer (NK) cells, and whether UD TGFbetai NK cells with temozolomide works to shrink tumors in patients with stage IV melanoma that has spread to the brain (metastatic to the brain). NK cells are immune cells that contribute to anti-tumor immunity by recognizing and destroying transformed or stressed cells. Temozolomide is in a class of medications called alkylating agents. It works by slowing or stopping the growth of cancer cells in the body. Giving UD TGFbetai NK cell and temozolomide may work better in treating patients with stage IV melanoma.

Conditions

Clinical Stage IV Cutaneous Melanoma AJCC v8

Metastatic Malignant Neoplasm in the Brain

Metastatic Melanoma

Pathologic Stage IV Cutaneous Melanoma AJCC v8

Study ID

NCT05588453

Start date

Mar 1, 2023

Status verified date

Apr, 2026

Completion date

Apr 15, 2027

Anticipated

Primary completion date

Apr 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Histologically confirmed melanoma with stage IV disease
  • Radiologically confirmed brain metastasis (n >= 1) with at least one measurable central nervous system (CNS) lesion >= 10 mm on T1-weighted gadolinium enhanced magnetic resonance imaging (MRI) and unequivocal evidence of progression
  • No indication for stereotactic radiotherapy
  • At least 4 weeks from any anticancer treatment (cytotoxic chemotherapy, signal transduction inhibitors, immunotherapy or radiation)
  • Absolute neutrophil count (ANC) 1 x 10\^9/L
  • Platelets > 100,000/L
  • Hemoglobin (Hgb) >= 10 g/dL
  • Creatinine =< 1.5 x upper limit of normal (ULN)
  • Albumin >= 2.5 g/dL
  • Serum bilirubin < 1.5 x ULN unless due to Gilbert's syndrome
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 5 x ULN if documented liver metastases or < 3 X ULN without liver metastasis
  • > 18 years old (y/o)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Females of reproductive age must agree to the use of an effective contraceptive method while on treatment, beginning 2 weeks before the first dose of investigational product and for 28 days after the final dose of investigational product for women. Males able to father a child must practice adequate methods of contraception or completely abstain from intercourse from the first dose of investigational treatment until one week after the final dose of investigational treatment
  • Women of childbearing potential must have a negative serum pregnancy test within 14 days of enrollment and/or urine pregnancy test 48 hours prior to the administration of the first study treatment
  • Patient information and written informed consent form signed

Exclusion Criteria:

  • Planned or concurrent systemic treatment or radiation therapy
  • If requiring corticosteroids for cerebral edema, patients must be on a stable dose. Lowest dose of steroids needed to control CNS edema is recommended. Doses above 4 mg daily need to be cleared by principal investigator (PI) of the study
  • Known contra-indication to MRI
  • Patients with non-melanoma malignancies are excluded unless a complete remission has been achieved at least 3 years prior to study entry and no additional therapy is required or anticipated during the study period (exceptions include: non-melanoma skin cancers, in situ bladder cancer, in situ gastric cancer, in situ colon cancers, in situ cervical cancers/dysplasia, or in situ breast carcinoma)
  • Patients with other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study, such as:

  • Active infection
  • Current active hepatic or renal disease
  • Pregnant women, women who are likely to become pregnant or are breastfeeding
  • Patients with significantly altered mental status prohibiting the understanding of the study or with psychological, familial, sociological, or geographical conditions potentially hampering ability to consent, compliance with the study protocol, and follow-up schedule; those conditions should be discussed with the patient before remigration in the trial
  • Patients who received any other investigational drugs within the 30 days prior to screening visit
  • Leptomeningeal metastases diagnosed by MRI
  • Inclusion in another therapeutic protocol within 30 days
  • If steroids are necessary to control symptoms related to CNS metastases, patients should be on the lowest dose of steroids necessary to control symptoms

Study Design

Enrollment

24 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (UD TGFbetai NK cells, temozolomide)

Patients receive UD TGFbetai NK cells IV over 30 minutes on day 1 and temozolomide PO daily on days 1-5. Treatment with UD TGFbetai NK cells repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Cycles of temozolomide repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Interventions

Natural Killer Cell Therapy

Given UD TGFbi NK cell IV

Temozolomide

Given PO

Primary outcome measure

  • Dose limited toxicities (Phase I) [ Time Frame: Up to 28 days ]
  • Incidence of adverse events (AEs) (Phase I) [ Time Frame: Up to 5 years ]
  • Proportion of subjects who achieve an intracranial complete response or partial response (Phase II) [ Time Frame: Up to 5 years ]

Central Contacts and Locations

Central contacts

The Ohio State University Comprehensive Cancer Center

800-293-5066OSUCCCClinicaltrials@osumc.edu

Locations

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Kari L. Kendra, MD

614-293-7956Kari.Kendra@osumc.edu

Principal Investigator:

Kari L. Kendra, MD

More Information

Sponsor

Kari Kendra

Last update posted

Jun 11, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kari Kendra on 2026-06-11.