Clear Cell Renal Cell Carcinoma
Conditions
Keywords
Renal cell carcinoma, cell therapy, CD70, chimeric antigen receptor (CAR) t-cell therapy
Brief summary
This is a Phase 1/2 multicenter, open-label, dose escalation, and dose expansion study of ADI-270 - an Engineered gamma-delta Chimeric Receptor \[CAR\] Vδ1 T Cell product Targeting CD70 - in patients with R/R ccRCC.
Interventions
DRUGADI-270
Anti-CD70 CAR-T
DRUGFludarabine
Chemotherapy for Lymphodepeletion
DRUGCyclophosphamide
Chemotherapy for Lymphodepletion
Sponsors
Adicet Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
3+3 Dose Escalation Design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically or cytologically confirmed clear cell RCC 2. Documented evidence of advanced or metastatic diseases. 3. Patients must have been treated with an immune checkpoint inhibitor and a VEGF inhibitor (the VEGF inhibitor must have been administered in the advanced and/or metastatic setting). 4. At least one measurable target lesion according to RECIST 1.1 5. At least three weeks, or 5 half-lives, whichever is shorter, from the last dose of the prior line of systemic therapy 6. KPS ≥ 70
Exclusion criteria
1. Subjects with CNS metastases or spinal cord compression are not eligible, unless they have completed therapy and have discontinued the use of corticosteroids for at least 8 weeks and remained stable prior to enrollment. 2. Clinically significant CNS dysfunction of any etiology in the opinion of the Investigator. 3. Prior radiation therapy within 21 days prior to start of study treatment with the exception of palliative radiotherapy to bone lesions (palliative radiotherapy to bone lesions must be completed at least 2 weeks prior to the first dose of LD). 4. Active malignancy (except for RCC, definitively treated basal or squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix or bladder) within the past 24 months 5. Treatment with gene therapy, genetically modified cell therapy, or adoptive T cell therapy within 6 weeks before initiating LD in this study. 6. Receipt of CD70 targeted therapies for any indication 7. Require corticosteroid therapy \> 5 mg per day of prednisone or equivalent. 8. History of any form of primary immunodeficiency such as severe combined immunodeficiency disease. 9. Presence of active autoimmune disease requiring ongoing systemic immunosuppressive therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Incidence of Subjects with Dose Limiting Toxicities within each dose level cohort | Day 28 | This primary endpoint will be used to determine the Maximum Tolerated Dose (MTD) or Maximum Assessed dose (MAD) |
| Proportion of treatment emergent and treatment related adverse events | 2 years | This primary endpoint will be used to determine the MTD/MAD of ADI-270 |
Countries
United States
Outcome results
None listed