Clinical trial · Interventional
Safety and Efficacy of ALLO-316 in Subjects With Advanced or Metastatic Clear Cell Renal Cell Carcinoma
A Phase 1A/1B Multicenter Study Evaluating the Safety and Efficacy of ALLO-316 With Cyclophosphamide/Fludarabine Lymphodepletion Alone or Including ALLO-647 in Subjects With Advanced or Metastatic Clear Cell Renal Cell Carcinoma (ccRCC)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a Phase 1 dose escalation study using a 3+3 study design, followed by a phase 1b expansion study. The purpose of the TRAVERSE study is to assess the safety, efficacy, and cell kinetics of ALLO-316 in adults with advanced or metastatic clear cell renal cell carcinoma after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, with or without ALLO-647 to define a Phase 2 dose.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced/Metastatic Clear Cell Renal Cell Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ALLO-316 | Genetic | — | UNRESOLVED |
| ALLO-647 | Biological | Alemtuzumab | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ALLO-647, ALLO-316
- interventionNames
- Genetic: ALLO-316
- Biological: ALLO-647
- Drug: Fludarabine
- Drug: Cyclophosphamide
Primary outcomes (2)
- measure
- Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of ALLO-316
- timeFrame
- 28 days
- measure
- Proportion of patients experiencing Dose Limiting Toxicity with ALLO-647 in combination with fludarabine/cyclophosphamide administered prior to ALLO-316
- timeFrame
- 33 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 74 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed renal cell carcinoma with a predominant clear cell component. * Must have received a checkpoint inhibitor and a VEGF inhibitor in the advanced and/or metastatic setting. * At least one measurable lesion as defined by RECIST version 1.1 * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1. * Absence of donor (product)-specific anti-HLA antibodies (DSA). * Adequate hematological, renal, liver, pulmonary, and cardiac functions. Exclusion Criteria: * Central nervous system (CNS) metastatic disease (unless controlled and stable for at least 4 weeks), leptomeningeal disease, or cord compression. * Clinically significant CNS dysfunction. * Any other active malignancy within 3 years prior to enrollment. * Prior treatment with anti-CD70 therapies. * Current thyroid disorder (including hyperthyroidism) with the exception of hypothyroidism controlled on stable dose of hormone replacement therapy. * Prior treatment with anti-CD52 monoclonal antibody in the past 12 months. * Participants unwilling to participate in the extended safety monitoring period.
References
Publications (3)
- DERIVEDSrour SA, Chahoud J, Drakaki A, Curti BD, Gibney GT, Tang L, Jiang Y, Charmsaz S, Robbins PB, McLeroy J, Severyn CJ, Le Gall JB, Roberts ZJ, Tannir NM, Pal S, Kotecha RR. Allogeneic CD70-Targeted Chimeric Antigen Receptor T-Cell Therapy for Advanced Renal Cell Carcinoma: Results From the Phase I TRAVERSE Trial. J Clin Oncol. 2026 Jul 14:JCO2600388. doi: 10.1200/JCO-26-00388. Online ahead of print. PMID 42447427
- DERIVEDNamdari H, Rezaei F, Heidarnejad F, Yaghoubzad-Maleki M, Karamigolbaghi M. Immunoinformatics Approach to Design a Chimeric CD70-Peptide Vaccine against Renal Cell Carcinoma. J Immunol Res. 2024 Jan 27;2024:2875635. doi: 10.1155/2024/2875635. eCollection 2024. PMID 38314087
- DERIVEDDewulf J, Flieswasser T, Delahaye T, Vangestel C, Miranda A, de Haard H, Jacobs J, Smits E, Van den Wyngaert T, Elvas F. Site-specific 68Ga-labeled nanobody for PET imaging of CD70 expression in preclinical tumor models. EJNMMI Radiopharm Chem. 2023 Apr 24;8(1):8. doi: 10.1186/s41181-023-00194-3. PMID 37093350