Testing ADI-270 for advanced clear cell kidney cancer

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)

This study is testing a new treatment called ADI-270 to see if it can help people with advanced clear cell kidney cancer who haven't responded to other therapies.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Adicet Therapeutics (industry)
• Drugs / interventions: radiation, prednisone
• Locations: 1 site (Nashville, Tennessee)
• Trial ID: NCT06480565 on ClinicalTrials.gov

What this trial studies

This Phase 1/2 trial evaluates the safety and efficacy of ADI-270, an engineered gamma-delta CAR T cell therapy targeting CD70, in patients with relapsed or refractory clear cell renal cell carcinoma (ccRCC). The study involves a multicenter, open-label design with a dose escalation and expansion approach. Eligible participants must have advanced or metastatic ccRCC and have previously received specific immunotherapy treatments. The trial aims to assess the therapeutic potential of ADI-270 in this challenging cancer type.

Who should consider this trial

Good fit: Ideal candidates are patients with advanced or metastatic clear cell RCC who have previously been treated with immune checkpoint inhibitors and VEGF inhibitors.

Not a fit: Patients with CNS metastases or significant CNS dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced clear cell renal cell carcinoma.

How similar studies have performed: While CAR T cell therapies have shown promise in other cancers, this specific approach targeting CD70 in ccRCC is novel and has not been extensively tested.

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.

Where this trial is running

Nashville, Tennessee

• Sarah Cannon Research Institute Oncology Partners — Nashville, Tennessee, United States (RECRUITING)

Study contacts

• Study coordinator: Adicet Medical Director

Conditions: Clear Cell Renal Cell Carcinoma, Renal cell carcinoma, cell therapy, CD70, chimeric antigen receptor t-cell therapy