Evaluating ALLO-316 for advanced kidney cancer
A Phase 1 Multicenter Study Evaluating the Safety and Efficacy of ALLO-316 Following ALLO-647 Containing Conditioning Regimen in Subjects With Advanced or Metastatic Clear Cell Renal Cell Carcinoma
This study is testing a new treatment called ALLO-316 for adults with advanced kidney cancer to see if it is safe and effective.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Allogene Therapeutics Industry-sponsored |
| Drugs / interventions | cyclophosphamide, fludarabine |
| Locations | 10 sites (Duarte, California and 9 other locations) |
| Trial ID | NCT04696731 on ClinicalTrials.gov |
What this trial studies
This Phase 1 dose escalation study aims to assess the safety and efficacy of ALLO-316 in adults with advanced or metastatic clear cell renal cell carcinoma. Participants will undergo a lymphodepletion regimen with fludarabine, cyclophosphamide, and ALLO-647 before receiving ALLO-316. The study follows a 3+3 design to determine the appropriate dosing for a subsequent Phase 2 trial. The focus is on understanding cell kinetics and overall treatment response.
Who should consider this trial
Good fit: Ideal candidates include adults with histologically confirmed clear cell renal cell carcinoma who have previously received checkpoint and VEGF inhibitors.
Not a fit: Patients with central nervous system metastases or other active malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced kidney cancer who have limited treatment alternatives.
How similar studies have performed: While CAR T-cell therapies are a growing field, this specific approach using ALLO-316 in renal cell carcinoma is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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. * Patients unwilling to participate in the extended safety monitoring period.
Where this trial is running
Duarte, California and 9 other locations
- City of Hope — Duarte, California, United States (Terminated)
- UCLA Medical Center — Los Angeles, California, United States (Recruiting)
- UCSF Medical Center — San Francisco, California, United States (Recruiting)
- Yale School of Medicine — New Haven, Connecticut, United States (Recruiting)
- Georgetown University Hospital — Washington, District of Columbia, United States (Recruiting)
- Moffitt Cancer Center — Tampa, Florida, United States (Recruiting)
- Karmanos Cancer Institute — Detroit, Michigan, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- Providence Portland Medical Center — Portland, Oregon, United States (Active_not_recruiting)
- MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Allogene
- Email: clinicaltrials@allogene.com
- Phone: 415-604-5696
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.