A Safety and Efficacy Study Evaluating CTX130 in Subjects With Relapsed or Refractory Renal Cell Carcinoma (COBALT-RCC)

Renal Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04438083
• Other study ID #: CRSP-ONC-003
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: June 16, 2020
• Est. completion date: April 2027

Study information

• Verified date: May 2024
• Source: CRISPR Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The study may enroll approximately 107subjects in total.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 107
• Est. completion date: April 2027
• Est. primary completion date: February 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Abbreviated Inclusion Criteria:

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 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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Biological:
• CTX130
CTX130 CD70-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components.

Locations

Country	Name	City	State
Australia	Research Site 1	Melbourne	Victoria
Canada	Research Site 6	Toronto	Ontario
Netherlands	Research Site 7	Amsterdam	North Holland
United States	Research Site 2	Duarte	California
United States	Research Site 5	Hartford	Connecticut
United States	Research Site 4	Houston	Texas
United States	Research Site 3	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
CRISPR Therapeutics AG

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part A (dose escalation): Incidence of adverse events	Adverse events defined as dose-limiting toxicities	From CTX130 infusion up to 28 days post-infusion
Primary	Part B (cohort expansion): Objective response rate	Objective response rate per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1	From CTX130 infusion up to 60 months post-infusion]
Secondary	Progression Free Survival		From date of CTX130 infusion until date of disease progression or death due to any cause, assessed up to 60 months
Secondary	Overall Survival		From date of CTX130 until date of death due to any cause, assessed up to 60 months