NCT04696731
Active, not recruiting
Phase 1
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)
Overview
- Phase
- Phase 1
- Intervention
- Fludarabine
- Conditions
- Advanced/Metastatic Clear Cell Renal Cell Carcinoma
- Sponsor
- Allogene Therapeutics
- Enrollment
- 120
- Locations
- 10
- Primary Endpoint
- Proportion of patients experiencing Dose Limiting Toxicity with ALLO-647 in combination with fludarabine/cyclophosphamide administered prior to ALLO-316
- Status
- Active, not recruiting
- Last Updated
- 7 months ago
Overview
Brief Summary
This is a Phase 1 dose escalation study following a 3+3 study design. 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.
Investigators
Eligibility 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
- •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.
Arms & Interventions
ALLO-647, ALLO-316
Intervention: Fludarabine
ALLO-647, ALLO-316
Intervention: ALLO-316
ALLO-647, ALLO-316
Intervention: ALLO-647
ALLO-647, ALLO-316
Intervention: Cyclophosphamide
Outcomes
Primary Outcomes
Proportion of patients experiencing Dose Limiting Toxicity with ALLO-647 in combination with fludarabine/cyclophosphamide administered prior to ALLO-316
Time Frame: 33 days
Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of ALLO-316
Time Frame: 28 days
Study Sites (10)
Loading locations...
Similar Trials
Unknown
Phase 1
YL-13027 in Patients With Advanced Solid TumorsSolid TumorNCT05228600Shanghai YingLi Pharmaceutical Co. Ltd.54
Recruiting
Phase 1
Phase I Study VG2025 as a Single Agent and in Combination Therapy With Nivolumab in Subjects With Advanced Malignant Solid TumorsSolid TumorNCT05266612Virogin Biotech Canada Ltd12
Completed
Phase 1
Assessment of Safety and Efficacy of Estetrol in Postmenopausal Women With Advanced Estrogen Receptor Positive (ER+) Breast CancerBreast NeoplasmsNCT02718144Pantarhei Oncology B.V.12
Terminated
Phase 1
Autologous Polyclonal Tregs for LupusLupus Erythematosus, CutaneousLupus Erythematosus, DiscoidLupus Erythematosus, SystemicNCT02428309National Institute of Allergy and Infectious Diseases (NIAID)1
Recruiting
Phase 1
A Study of BL-B16D1 in Patients With Locally Advanced or Metastatic Solid TumorsSolid TumorNCT06475131Sichuan Baili Pharmaceutical Co., Ltd.21
Related News
ALLO-316 CAR-T Therapy Shows Promise in Renal Cell Carcinoma Trial, but Deaths Reported• Allogene's ALLO-316 demonstrated a 38% overall response rate in renal cell carcinoma patients at dose level 2 in the TRAVERSE phase 1 trial.
• In patients with high CD70 expression, ALLO-316 achieved a confirmed overall response rate of 33%, indicating potential for targeted therapy.
• The trial reported a manageable safety profile, with mostly low-grade cytokine release syndrome, but included three on-study patient deaths.
• ALLO-316, an off-the-shelf CAR-T therapy, shows potential as a novel treatment for metastatic RCC resistant to multiple therapeutic classes.ALLO-316 Demonstrates Promising Response in CD70-Positive Renal Cell Carcinoma• A phase 1 trial of ALLO-316 showed a 50% overall response rate in patients with CD70-positive renal cell carcinoma (RCC) with a tumor proportion score (TPS) of ≥50%.
• The study also reported a 33% confirmed response rate among patients with CD70-positive RCC, indicating potential efficacy in heavily pretreated patients.
• The most common adverse events were cytokine release syndrome, fatigue, and neutropenia, with a manageable safety profile observed in the trial.
• These findings suggest that ALLO-316, an off-the-shelf CAR T-cell therapy, could represent a significant advancement in treating advanced RCC.ALLO-316 Receives FDA RMAT Designation for CD70+ Advanced Renal Cell Carcinoma• The FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to ALLO-316 for CD70-positive advanced or metastatic renal cell carcinoma.
• The RMAT designation was supported by phase 1 TRAVERSE trial data, which showed promising overall response and disease control rates.
• In CD70-positive patients, ALLO-316 demonstrated a 30% overall response rate and a 100% disease control rate in the trial.
• ALLO-316's adverse effect profile was consistent with autologous CAR T-cell therapies, with manageable safety observed in the trial.ALLO-316 Granted RMAT Designation by FDA for Advanced Renal Cell Carcinoma- The FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to ALLO-316 for advanced or metastatic renal cell carcinoma.
- The RMAT designation aims to expedite the development and review of ALLO-316, an AlloCAR T therapy.
- Phase 1 TRAVERSE trial data supports the RMAT designation, showing promising disease control and response rates in CD70-expressing RCC patients.
- ALLO-316 demonstrated a manageable safety profile, consistent with other CAR T therapies, in heavily pretreated patients.