Back to resultsA Safety and Efficacy Study Evaluating CTX130 in Subjects With Relapsed or Refractory Renal Cell Carcinoma (COBALT-RCC)
Primary Purpose
Renal Cell Carcinoma
Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
CTX130
Sponsored by
About this trial
This is an interventional treatment trial for Renal Cell Carcinoma focused on measuring CAR T, Allogeneic, Renal cell carcinoma, Renal cell carcinoma with clear cell differentiation, CRISPR-Cas9
Eligibility Criteria
Abbreviated Inclusion Criteria:
- Age ≥18 years and body weight ≥42 kg.
- Unresectable or metastatic RCC that has exploited standard of care treatment.
- Karnofsky performance status (KPS) ≥80%.
- Adequate renal, liver, cardiac, and pulmonary organ function.
- Female subjects of childbearing potential and male subjects must agree to use acceptable method(s) of contraception from enrollment through at least 12 months after CTX130 infusion.
Abbreviated Exclusion Criteria:
- Prior treatment with any anti-CD70 targeting agents.
- Prior treatment with any CAR T cells or any other modified T or natural killer (NK) cells.
- History of certain central nervous system (CNS), cardiac or pulmonary conditions.
- Active HIV, hepatitis B virus or hepatitis C virus infection.
- Previous or concurrent malignancy, except treated with curative approach not requiring systemic therapy and in remission for >12 months, or any other localized malignancy with low risk of developing into metastatic disease.
- Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy.
- Prior solid organ transplantation or bone marrow transplant.
- Pregnant or breastfeeding females.
Sites / Locations
- Research Site 2
- Research Site 5
- Research Site 4
- Research Site 3
- Research Site 1
- Research Site 6
- Research Site 7
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CTX130
Arm Description
Administered by IV infusion following lymphodepleting chemotherapy.
Outcomes
Primary Outcome Measures
Part A (dose escalation): Incidence of adverse events
Adverse events defined as dose-limiting toxicities
Part B (cohort expansion): Objective response rate
Objective response rate per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
Secondary Outcome Measures
Progression Free Survival
Overall Survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04438083
Brief Title
A Safety and Efficacy Study Evaluating CTX130 in Subjects With Relapsed or Refractory Renal Cell Carcinoma (COBALT-RCC)
Official Title
A Phase 1 Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of Allogeneic CRISPR-Cas9-Engineered T Cells (CTX130) in Subjects With Advanced, Relapsed or Refractory Renal Cell Carcinoma With Clear Cell Differentiation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 16, 2020 (Actual)
Primary Completion Date
February 2027 (Anticipated)
Study Completion Date
April 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CRISPR Therapeutics AG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a single-arm, open-label, multicenter, Phase 1 study evaluating the safety and efficacy of CTX130 in subjects with relapsed or refractory renal cell carcinoma.
Detailed Description
The study may enroll approximately 107subjects in total.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma
Keywords
CAR T, Allogeneic, Renal cell carcinoma, Renal cell carcinoma with clear cell differentiation, CRISPR-Cas9
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
107 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CTX130
Arm Type
Experimental
Arm Description
Administered by IV infusion following lymphodepleting chemotherapy.
Intervention Type
Biological
Intervention Name(s)
CTX130
Intervention Description
CTX130 CD70-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components.
Primary Outcome Measure Information:
Title
Part A (dose escalation): Incidence of adverse events
Description
Adverse events defined as dose-limiting toxicities
Time Frame
From CTX130 infusion up to 28 days post-infusion
Title
Part B (cohort expansion): Objective response rate
Description
Objective response rate per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
Time Frame
From CTX130 infusion up to 60 months post-infusion]
Secondary Outcome Measure Information:
Title
Progression Free Survival
Time Frame
From date of CTX130 infusion until date of disease progression or death due to any cause, assessed up to 60 months
Title
Overall Survival
Time Frame
From date of CTX130 until date of death due to any cause, assessed up to 60 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Abbreviated Inclusion Criteria:
Age ≥18 years and body weight ≥42 kg.
Unresectable or metastatic RCC that has exploited standard of care treatment.
Karnofsky performance status (KPS) ≥80%.
Adequate renal, liver, cardiac, and pulmonary organ function.
Female subjects of childbearing potential and male subjects must agree to use acceptable method(s) of contraception from enrollment through at least 12 months after CTX130 infusion.
Abbreviated Exclusion Criteria:
Prior treatment with any anti-CD70 targeting agents.
Prior treatment with any CAR T cells or any other modified T or natural killer (NK) cells.
History of certain central nervous system (CNS), cardiac or pulmonary conditions.
Active HIV, hepatitis B virus or hepatitis C virus infection.
Previous or concurrent malignancy, except treated with curative approach not requiring systemic therapy and in remission for >12 months, or any other localized malignancy with low risk of developing into metastatic disease.
Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy.
Prior solid organ transplantation or bone marrow transplant.
Pregnant or breastfeeding females.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alissa Keegan, MD
Organizational Affiliation
CRISPR Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Research Site 2
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Research Site 5
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Research Site 4
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Research Site 3
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Research Site 1
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Facility Name
Research Site 6
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Research Site 7
City
Amsterdam
State/Province
North Holland
ZIP/Postal Code
1066
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
A Safety and Efficacy Study Evaluating CTX130 in Subjects With Relapsed or Refractory Renal Cell Carcinoma (COBALT-RCC)
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