TRAVERSE: Safety and Efficacy of ALLO-316 in Subjects With Advanced or Metastatic Clear Cell Renal Cell Carcinoma

Sponsor

Allogene Therapeutics (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04696731

Collaborator

(none)

120

Enrollment

Locations

Arm

55.2

Anticipated Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Advanced/Metastatic Clear Cell Renal Cell Carcinoma	Genetic: ALLO-316 Biological: ALLO-647 Drug: Fludarabine Drug: Cyclophosphamide	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Feb 24, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Oct 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ALLO-647, ALLO-316	Genetic: ALLO-316 ALLO-316 is an allogeneic CAR T cell therapy targeting CD70 Biological: ALLO-647 ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen Drug: Fludarabine Chemotherapy for lymphodepletion Drug: Cyclophosphamide Chemotherapy for lymphodepletion

Arm

Intervention/Treatment

Experimental: ALLO-647, ALLO-316

Genetic: ALLO-316

ALLO-316 is an allogeneic CAR T cell therapy targeting CD70

Biological: ALLO-647

ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen

Drug: Fludarabine

Chemotherapy for lymphodepletion

Drug: Cyclophosphamide

Chemotherapy for lymphodepletion

Outcome Measures

Primary Outcome Measures

Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of ALLO-316 [28 days]
Proportion of patients experiencing Dose Limiting Toxicity with ALLO-647 in combination with fludarabine/cyclophosphamide administered prior to ALLO-316 [33 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	City of Hope	Duarte	California	United States	91010
2	UCLA Medical Center	Los Angeles	California	United States	90095
3	Moffitt Cancer Center	Tampa	Florida	United States	33612
4	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
5	Providence Portland Medical Center	Portland	Oregon	United States	97213
6	MD Anderson Cancer Center	Houston	Texas	United States	77030