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

• ClinicalTrials.gov Identifier: NCT04438083
• Recruitment Status: Recruiting
• First Posted: June 18, 2020
• Last Update Posted: May 17, 2022
• Sponsor: CRISPR Therapeutics AG
• Information provided by (Responsible Party): CRISPR Therapeutics ( CRISPR Therapeutics AG )

Tracking Information

• First Submitted Date: June 16, 2020
• First Posted Date: June 18, 2020
• Last Update Posted Date: May 17, 2022
• Actual Study Start Date: June 16, 2020
• Estimated Primary Completion Date: February 2027 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 16, 2020)

• Part A (dose escalation): Incidence of adverse events [ Time Frame: From CTX130 infusion up to 28 days post-infusion ]
  Adverse events defined as dose-limiting toxicities
• Part B (cohort expansion): Objective response rate [ Time Frame: From CTX130 infusion up to 60 months post-infusion] ]
  Objective response rate per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 16, 2020)

• 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 ]
• Overall Survival [ Time Frame: From date of CTX130 until date of death due to any cause, assessed up to 60 months ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: N/A; Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: 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.

Study Arms

Experimental: CTX130

Administered by IV infusion following lymphodepleting chemotherapy.

Intervention: Biological: CTX130

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: February 9, 2021): 107
• Original Estimated Enrollment (submitted: June 16, 2020): 95
• Estimated Study Completion Date: April 2027
• Estimated Primary Completion Date: February 2027 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Clinical Trials; +1 (877) 214-4634; MedicalAffairs@crisprtx.com

• Listed Location Countries: Australia, Canada, Netherlands, United States

Administrative Information

• NCT Number: NCT04438083
• Other Study ID Numbers: CRSP-ONC-003
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: CRISPR Therapeutics ( CRISPR Therapeutics AG )
• Original Responsible Party: Same as current
• Current Study Sponsor: CRISPR Therapeutics AG
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Anjali Sharma, MD; CRISPR Therapeutics

• PRS Account: CRISPR Therapeutics
• Verification Date: May 2022