Clinical trial NCT04696731: Safety and Efficacy of ALLO-316 in Subjects With Advanced or Metastatic Clear Cell Renal Cell Carcinoma
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
Overall status: RECRUITING
Phase: PHASE1
Conditions: 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
Lead sponsor: Allogene Therapeutics
Sponsor class: INDUSTRY
First posted: 2021-01-06
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
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
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: San Francisco
country: United States
facility: UCSF Medical Center
state: California
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
city: Washington
country: United States
facility: Georgetown University Hospital
state: District of Columbia
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
References: