Recruiting
Phase 1

IL-8 CAR T Cells

Sponsor:

University of Florida

Code:

NCT07569263

Conditions

Brain Metastases

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Ex-Vivo expanded autologous IL-8 receptor (CXCR2) modified CD70 CAR (8R-70CAR) T cells

CD70 IHC assay

Study Details

Brief summary:

This is a Phase I Study evaluating the safety and feasibility of IL-8 receptor-modified patient-derived activated CD70 CAR T cells in adult patients with brain metastases from primary cancer, with either newly diagnosed lesions or recurrent or progressive disease after prior therapy.

Conditions

Brain Metastases

Study ID

NCT07569263

Start date

Oct 13, 2026

Status verified date

Oct, 2026

Completion date

Dec, 2044

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Histological confirmation of primary cancers
  • Histologic confirmation of CD70 on primary tumor, lymph node, or BM biopsy CD70-positive tumor expression confirmed by the investigational CD70 IHC assay defined as CD70 immunoreactivity in ≥ 5% of tumor cells at any staining intensity.
  • At least one recurrent or progressive metastatic lesion or new metastatic lesion(s).
  • KPS ≥ 70.
  • 18 years or older.
  • Adequate bone marrow and organ function as defined below:

  • CBC with differential with adequate bone marrow function as defined below:
  • Absolute neutrophil count (ANC) ≥ 1000 cells/mm3.
  • Platelet count ≥ 75,000 cells/mm3.
  • Hemoglobin ≥ 9 g/dl. (use of transfusion or other intervention to achieve Hgb ≥ 9 g/dl is acceptable.)
  • Adequate renal function as defined below:

  • BUN ≤ 25 mg/dl
  • Creatinine ≤ 1.7 mg/dl
  • Adequate hepatic function as defined below:

  • Bilirubin ≤ 2.0 mg/dl
  • ALT ≤ 5 times institutional upper limits of normal for age
  • AST ≤ 5 times institutional upper limits of normal for age
  • A diagnostic contrast-enhanced brain MRI must be performed within 28 days prior to study enrollment.
  • For females of childbearing potential, a negative serum pregnancy test at enrollment.
  • Women of childbearing potential (WOCBP) must be willing to use an acceptable contraceptive method to avoid pregnancy throughout the study and for at least 24 weeks after the last dose of study drug.
  • Males with female partners of childbearing potential must agree to practice adequate contraceptive methods throughout the study and should avoid conceiving children for 24 weeks following the last dose of the study drug.
  • Ability of the patient to understand and willingness to sign an IRB approved written informed consent document.
  • Steroid dose equivalent to dexamethasone dose of ≤ 6mg daily at the time of enrollment.
  • Patients treated on any other investigational therapy must discontinue that treatment prior to study entry.

Exclusion Criteria:

• Known immunosuppressive disease or human immunodeficiency virus (HIV) infection.

Rationale: The need to exclude patients with an immunosuppressive disease or human immunodeficiency virus infection is necessary because the management of potential toxicities from the study drug may involve treatment that is significantly immunosuppressive.

  • Participant has ongoing toxicity ≥ grade 2 per the CTCAE version 5.0 considered clinically significant and in the opinion of the investigator, attributable to prior antineoplastic therapies.
  • Participant has received any chemotherapy or other immunotherapy within 14 days prior to the first dose of study intervention.
  • Severe, active co-morbidity, defined as follows:

  • Unstable angina and/or congestive heart failure requiring hospitalization.
  • Transmural myocardial infarction within the last 6 months.
  • Acute bacterial or fungal infection requiring intravenous antibiotics.
  • Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization.
  • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects.
  • Patients with an autoimmune disease requiring medical management with immunosuppressants.
  • Major medical illnesses or psychiatric impairments that, in the investigator's opinion, will prevent administration or completion of protocol therapy.
  • Pregnant or lactating women, due to possible adverse effects on the developing fetus or infant.

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: IL-8 receptor-modified patient-derived activated CD70 CAR T cells

Two dose levels Cohort 1 will receive 1 x 10\^7 cells/kg; Cohort 2 will receive 1 x 10\^8 cells/kg

Interventions

Ex-Vivo expanded autologous IL-8 receptor (CXCR2) modified CD70 CAR (8R-70CAR) T cells

Single dose of 8R-70CAR T cells administered IV

CD70 IHC assay

CD70 expression will be assessed during screening using available tumor tissue obtained as part of routine clinical care from the primary tumor, lymph node, or brain metastasis, as applicable. The CD70 IHC result will be used to determine study eligibility. CD70 expression will be evaluated using an investigational immunohistochemistry (IHC) assay.

Primary outcome measure

  • Number and percentage of participants with dose-limiting toxicities after receiving 8R-70CAR T-cell therapy [ Time Frame: 28 days post-infusion ]
  • Proportion of participants who receive an infusion of 8R-70CAR T-cell therapy [ Time Frame: enrollment up to 10 weeks ]

Central Contacts and Locations

Central contacts

Locations

UF Health

Recruiting

Gainesville, Florida, United States, 32610

Contacts

More Information

Sponsor

University of Florida

Last update posted

Oct 16, 2026

Last verified

Oct, 2026

Keywords

  • Immunotherapy
  • CAR T cells

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-18. This information was provided to ClinicalTrials.gov by University of Florida on 2026-10-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.