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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04438083




Registration number
NCT04438083
Ethics application status
Date submitted
16/06/2020
Date registered
18/06/2020
Date last updated
21/05/2024

Titles & IDs
Public title
A Safety and Efficacy Study Evaluating CTX130 in Subjects With Relapsed or Refractory Renal Cell Carcinoma (COBALT-RCC)
Scientific 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
Secondary ID [1] 0 0
CRSP-ONC-003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal Cell Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - CTX130

Experimental: CTX130 - Administered by IV infusion following lymphodepleting chemotherapy.


Other interventions: CTX130
CTX130 CD70-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part A (dose escalation): Incidence of adverse events
Timepoint [1] 0 0
From CTX130 infusion up to 28 days post-infusion
Primary outcome [2] 0 0
Part B (cohort expansion): Objective response rate
Timepoint [2] 0 0
From CTX130 infusion up to 60 months post-infusion]
Secondary outcome [1] 0 0
Progression Free Survival
Timepoint [1] 0 0
From date of CTX130 infusion until date of disease progression or death due to any cause, assessed up to 60 months
Secondary outcome [2] 0 0
Overall Survival
Timepoint [2] 0 0
From date of CTX130 until date of death due to any cause, assessed up to 60 months

Eligibility
Key inclusion criteria
Abbreviated

1. Age =18 years and body weight =42 kg.

2. Unresectable or metastatic RCC that has exploited standard of care treatment.

3. Karnofsky performance status (KPS) =80%.

4. Adequate renal, liver, cardiac, and pulmonary organ function.

5. 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Prior treatment with any anti-CD70 targeting agents.

2. Prior treatment with any CAR T cells or any other modified T or natural killer (NK)
cells.

3. History of certain central nervous system (CNS), cardiac or pulmonary conditions.

4. Active HIV, hepatitis B virus or hepatitis C virus infection.

5. 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.

6. Primary immunodeficiency disorder or active autoimmune disease requiring steroids
and/or other immunosuppressive therapy.

7. Prior solid organ transplantation or bone marrow transplant.

8. Pregnant or breastfeeding females.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/06/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2027
Actual
Sample size
Target
107
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Research Site 1 - Melbourne
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
United States of America
State/province [4] 0 0
Utah
Country [5] 0 0
Canada
State/province [5] 0 0
Ontario
Country [6] 0 0
Netherlands
State/province [6] 0 0
North Holland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
CRISPR Therapeutics AG
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04438083
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Alissa Keegan, MD
Address 0 0
CRISPR Therapeutics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04438083