IL-8 Receptor Modified Patient-Derived Activated CD70 CAR T Cell Therapy in Adults With Brain Met… (NCT07569263) | Clinical Trial Compass
Not Yet RecruitingPhase 1
IL-8 Receptor Modified Patient-Derived Activated CD70 CAR T Cell Therapy in Adults With Brain Metastases
United States12 participantsStarted 2026-07
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
* 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 s…
What they're measuring
1
Number and percentage of participants with dose-limiting toxicities after receiving 8R-70CAR T-cell therapy
Timeframe: 28 days post-infusion
2
Proportion of participants who receive an infusion of 8R-70CAR T-cell therapy