ACTIVE_NOT_RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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)

Quick Facts

Study Start:2024-12-12

Study Completion:2027-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06480565

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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.

Inclusion Criteria

Exclusion 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

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.

Contacts and Locations

Study Locations (Sites)

Adicet Clinical Trials

Redwood City, California, 94065

United States

Collaborators and Investigators

Sponsor: Adicet Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-12

Study Completion Date2027-06

Study Record Updates

Study Start Date2024-12-12

Study Completion Date2027-06

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Clear Cell Renal Cell Carcinoma