Back to search results

8R-70CAR T Cell Therapy for Brain Metastases

This study is testing a new cell therapy called 8R-70CAR T cells for adults with brain metastases (cancer that has spread to the brain). These T cells are taken from your own body, modified in the lab, and then given back to you. Researchers want to see how safe this treatment is and if it can be given successfully. To join, you must have a confirmed diagnosis of brain metastases and your tumor must show a specific marker called CD70. The study plans to enroll 12 participants. The current status of the study is unclear.

Study design
This is a Phase I study, meaning it's an early-stage trial focused on safety. It plans to enroll 12 participants.
What's involved
You would undergo screening, potentially a tumor biopsy, and may receive standard treatments for brain metastases. Your cells would be collected to create the 8R-70CAR T cells, and you might receive standard-of-care chemotherapy during this time. You would then receive a single intravenous (IV) dose of 8R-70CAR T cells.
Compensation
Not stated in the trial record.
Follow-up
Researchers will monitor for dose-limiting toxicities for 28 days after the infusion. They will also track whether you receive the 8R-70CAR T-cell therapy from enrollment up to 10 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07569263

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

Not Yet Recruiting
PHASE1Ages 18–80InterventionalTreatment
University of Florida
~12 participants
Updated 2026-05-06 on ClinicalTrials.gov
What's tested:Ex-Vivo expanded autologous IL-8 receptor (CXCR2) modified CD70 CAR (8R-70CAR) T cells

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number and percentage of participants with dose-limiting toxicities after receiving 8R-70CAR T-cell therapy
Measured over 28 days post-infusion
+1 more outcome measured

Conditions

Brain Metastases

Explore related trials

Metastatic Malignant Neoplasm in the BrainCD70 Antigen

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Maryam Rahman, MD · PRINCIPAL_INVESTIGATOR · University of Florida

Who to contact

Taryn King, RN
[email protected]
3522739000
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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.
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) ≥ 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
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

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.

What this trial measures

  • Number and percentage of participants with dose-limiting toxicities after receiving 8R-70CAR T-cell therapy28 days post-infusion

    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.

  • Proportion of participants who receive an infusion of 8R-70CAR T-cell therapyenrollment up to 10 weeks

    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).