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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Dose Expansion | Experimental | Dose Expansion with ADI-270 at the MTD/MAD to confirm recommended phase 2 dose (Part 2). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADI-270 | Drug | Anti-CD70 CAR-T |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adicet Clinical Trials | Redwood City | California | 94065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40592738 | Derived | 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. |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C024352 | fludarabine |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
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3+3 Dose Escalation Design
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| Fludarabine |
| Drug |
Chemotherapy for Lymphodepeletion |
|
| Cyclophosphamide | Drug | Chemotherapy for Lymphodepletion |
|
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |