A Phase 1/2 Trial of ADI-270 in ccRCC

NCT06480565 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: ADI-202427001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Clear Cell Renal Cell Carcinoma

Keywords

Renal cell carcinoma, cell therapy, CD70, chimeric antigen receptor (CAR) t-cell therapy

Outcome Measures

Primary Outcomes (2)

• The Incidence of Subjects with Dose Limiting Toxicities within each dose level cohort

  This primary endpoint will be used to determine the Maximum Tolerated Dose (MTD) or Maximum Assessed dose (MAD)

  Day 28

• Proportion of treatment emergent and treatment related adverse events

  This primary endpoint will be used to determine the MTD/MAD of ADI-270

  2 years

Study Arms (2)

Dose Escalation

EXPERIMENTAL

ADI-270 is administered at ascending dose levels as a single dose to determine the maximum tolerated dose (MTD) or maximum assessed dose (MAD) of ADI-270

Drug: ADI-270; Drug: Fludarabine; Drug: Cyclophosphamide

Dose Expansion

EXPERIMENTAL

Dose Expansion with ADI-270 at the MTD/MAD to confirm recommended phase 2 dose (Part 2).

Drug: ADI-270; Drug: Fludarabine; Drug: Cyclophosphamide

Interventions

ADI-270 DRUG

Anti-CD70 CAR-T

Dose Escalation; Dose Expansion

Fludarabine DRUG

Chemotherapy for Lymphodepeletion

Dose Escalation; Dose Expansion

Cyclophosphamide DRUG

Chemotherapy for Lymphodepletion

Dose Escalation; Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed clear cell RCC
• Documented evidence of advanced or metastatic diseases.
• 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).
• At least one measurable target lesion according to RECIST 1.1
• At least three weeks, or 5 half-lives, whichever is shorter, from the last dose of the prior line of systemic therapy
• KPS ≥ 70

You may not qualify if:

• 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.
• Clinically significant CNS dysfunction of any etiology in the opinion of the Investigator.
• 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).
• 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
• Treatment with gene therapy, genetically modified cell therapy, or adoptive T cell therapy within 6 weeks before initiating LD in this study.
• Receipt of CD70 targeted therapies for any indication
• Require corticosteroid therapy \> 5 mg per day of prednisone or equivalent.
• History of any form of primary immunodeficiency such as severe combined immunodeficiency disease.
• Presence of active autoimmune disease requiring ongoing systemic immunosuppressive therapy.

Sponsors & Collaborators

• Adicet Therapeutics: lead

Study Sites (1)

Adicet Clinical Trials

Redwood City, California, 94065, United States

Location

Related Publications (1)

• Nishimoto KP, Lamture G, Chanthery Y, Teague AG, Verma Y, Au M, Smith-Boeck M, Salum M, Murthy P, Gundurao SRY, Kaur R, Zhang J, Azameera A, Wong JTS, Speltz EB, Wang KM, Doan A, Sethuraman J, Bhatwala D, Giner-Rubio A, Puligujja P, Budworth H, Rold CJ, Panuganti S, Jakobovits A, Herrman M, Bhat A, Green S, Aftab BT. ADI-270: an armored allogeneic gamma delta T cell therapy designed to target CD70-expressing solid and hematologic malignancies. J Immunother Cancer. 2025 Jul 1;13(7):e011704. doi: 10.1136/jitc-2025-011704.

  PMID: 40592738 DERIVED

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

fludarabine; Cyclophosphamide

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 3+3 Dose Escalation Design

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: June 28, 2024
• Study Start: December 12, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)