Back to resultsSafety and Efficacy of ALLO-316 in Subjects With Advanced or Metastatic Clear Cell Renal Cell Carcinoma (TRAVERSE)
Primary Purpose
Advanced/Metastatic Clear Cell Renal Cell Carcinoma
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ALLO-316
ALLO-647
Fludarabine
Cyclophosphamide
Sponsored by
About this trial
This is an interventional treatment trial for Advanced/Metastatic Clear Cell Renal Cell Carcinoma focused on measuring CAR T, Cell Therapy, Allogeneic Cell Therapy, Cellular Immuno-therapy, AlloCAR T, ALLO-316, ALLO-647, CCRCC, Clear Cell Renal Cell Carcinoma
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 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.
Sites / Locations
- City of HopeRecruiting
- UCLA Medical CenterRecruiting
- Moffitt Cancer CenterRecruiting
- Memorial Sloan Kettering Cancer CenterRecruiting
- Providence Portland Medical CenterRecruiting
- MD Anderson Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ALLO-647, ALLO-316
Arm Description
Outcomes
Primary Outcome Measures
Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of ALLO-316
Proportion of patients experiencing Dose Limiting Toxicity with ALLO-647 in combination with fludarabine/cyclophosphamide administered prior to ALLO-316
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04696731
Brief Title
Safety and Efficacy of ALLO-316 in Subjects With Advanced or Metastatic Clear Cell Renal Cell Carcinoma
Acronym
TRAVERSE
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 24, 2021 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
October 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allogene Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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, and ALLO-647 to define a Phase 2 dose.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced/Metastatic Clear Cell Renal Cell Carcinoma
Keywords
CAR T, Cell Therapy, Allogeneic Cell Therapy, Cellular Immuno-therapy, AlloCAR T, ALLO-316, ALLO-647, CCRCC, Clear Cell Renal Cell Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ALLO-647, ALLO-316
Arm Type
Experimental
Intervention Type
Genetic
Intervention Name(s)
ALLO-316
Intervention Description
ALLO-316 is an allogeneic CAR T cell therapy targeting CD70
Intervention Type
Biological
Intervention Name(s)
ALLO-647
Intervention Description
ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Intervention Description
Chemotherapy for lymphodepletion
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
Chemotherapy for lymphodepletion
Primary Outcome Measure Information:
Title
Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of ALLO-316
Time Frame
28 days
Title
Proportion of patients experiencing Dose Limiting Toxicity with ALLO-647 in combination with fludarabine/cyclophosphamide administered prior to ALLO-316
Time Frame
33 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Allogene
Phone
415-604-5696
Email
clinicaltrials@allogene.com
Facility Information:
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Individual Site Status
Recruiting
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of ALLO-316 in Subjects With Advanced or Metastatic Clear Cell Renal Cell Carcinoma
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