Clinical trial NCT04438083: 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
Overall status: TERMINATED
Phase: PHASE1
Conditions: Renal Cell Carcinoma
Keywords: CAR T
Allogeneic
Renal cell carcinoma
Renal cell carcinoma with clear cell differentiation
CRISPR-Cas9
Lead sponsor: CRISPR Therapeutics
Sponsor class: INDUSTRY
First posted: 2020-06-18
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Part A (dose escalation): Incidence of adverse events
timeFrame: From CTX130 infusion up to 28 days post-infusion
measure: Part B (cohort expansion): Objective response rate
timeFrame: From CTX130 infusion up to 60 months post-infusion]
Secondary outcomes:
measure: Progression Free Survival
timeFrame: From date of CTX130 infusion until date of disease progression or death due to any cause, assessed up to 60 months
measure: Overall Survival
timeFrame: From date of CTX130 until date of death due to any cause, assessed up to 60 months
Other outcomes:
Locations:
city: Duarte
country: United States
facility: Research Site 2
state: California
city: Hartford
country: United States
facility: Research Site 5
state: Connecticut
city: Houston
country: United States
facility: Research Site 4
state: Texas
city: Salt Lake City
country: United States
facility: Research Site 3
state: Utah
city: Melbourne
country: Australia
facility: Research Site 1
state: Victoria
city: Toronto
country: Canada
facility: Research Site 6
state: Ontario
city: Amsterdam
country: Netherlands
facility: Research Site 7
state: North Holland
Study officials:
affiliation: CRISPR Therapeutics
name: Alissa Keegan, MD
role: STUDY_DIRECTOR
References: