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

Adicet Therapeutics

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Clear Cell Renal Cell Carcinoma

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06480565

ADI-202427001

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Dose Escalation

Experimental group

Description:

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

Treatment:

Drug: ADI-270

Drug: Cyclophosphamide

Drug: Fludarabine

Dose Expansion

Experimental group

Description:

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

Treatment:

Drug: ADI-270

Drug: Cyclophosphamide

Drug: Fludarabine