IL-8 Receptor Modified Patient-Derived Activated CD70 CAR T Cell Therapy in Adults With Brain Metastases

NCT07569263 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: IRB202600387OCR49765
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Keywords

Immunotherapy; CAR T cells

Outcome Measures

Primary Outcomes (2)

• Number and percentage of participants with dose-limiting toxicities after receiving 8R-70CAR T-cell therapy

  Safety is defined as ≤ 1 DLT out of 6 patients is observed at the 1x10\^8 cells/Kg dose. Dose-Limiting toxicity (DLT) will be defined as any adverse event attributable (possible, probable, or definite) to the administration of 8R-70CAR T cells and occurring from the time of infusion through 28 days post-infusion. Safety variables and variables that define the DLTs will be summarized using descriptive statistics by dose level. Number and percentage of patients with DLTs and its 95% confidence interval (CI) will be estimated based on the exact binomial distribution by dose level.

  28 days post-infusion

• Proportion of participants who receive an infusion of 8R-70CAR T-cell therapy

  Feasibility will be defined as the ability to infuse 8R-70CAR T-cell safely in 66.7 % of enrolled patients (patients who signed consent and were deemed eligible for the study).

  enrollment up to 10 weeks

Study Arms (1)

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

EXPERIMENTAL

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

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

Interventions

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

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

Also known as: 8R-70 CAR T Cells

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological confirmation of primary cancers
• Histologic confirmation of CD70 on primary tumor, lymph node, or BM biopsy
• At least one recurrent or progressive metastatic lesion or new metastatic lesion(s).
• KPS ≥ 70.
• 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) ≥ 10000 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

UF Health

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Receptors, Interleukin-8B

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Receptors, Interleukin-8; Receptors, CXCR; Receptors, Chemokine; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Cytokine; Receptors, Immunologic; Receptors, Interleukin

Study Officials

• Maryam Rahman, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Taryn King, RN

CONTACT

3522739000; Wells-BTC@ufl.edu

Study Design

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

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 6, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2044
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)