Clinical trial NCT06480565: A Phase 1/2 Trial of ADI-270 in CcRCC
Official title: A Phase 1/2 Trial of ADI-270 (Engineered Γδ Chimeric Receptor [CAR] Vδ1 T Cells Targeting CD70) in Adults with Relapsed or Refractory (R/R) Clear Cell Renal Cell Carcinoma (ccRCC)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Clear Cell Renal Cell Carcinoma
Keywords: Renal cell carcinoma, cell therapy, CD70, chimeric antigen receptor (CAR) t-cell therapy
Lead sponsor: Adicet Therapeutics
Sponsor class: INDUSTRY
First posted: 2024-06-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 3+3 Dose Escalation Design
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The Incidence of Subjects with Dose Limiting Toxicities within each dose level cohort
timeFrame: Day 28
measure: Proportion of treatment emergent and treatment related adverse events
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Sarah Cannon Research Institute Oncology Partners
state: Tennessee
Study officials:
References: