A Safety and Efficacy Study Evaluating CTX130 in Subjects With Relapsed or Refractory Renal Cell Carcinoma (COBALT-RCC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04438083|
Recruitment Status : Active, not recruiting
First Posted : June 18, 2020
Last Update Posted : May 11, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Renal Cell Carcinoma||Biological: CTX130||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||107 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||June 16, 2020|
|Estimated Primary Completion Date :||February 2027|
|Estimated Study Completion Date :||April 2027|
Administered by IV infusion following lymphodepleting chemotherapy.
CTX130 CD70-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components.
- 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
- 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 ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04438083
|United States, California|
|Research Site 2|
|Duarte, California, United States, 91010|
|United States, Connecticut|
|Research Site 5|
|Hartford, Connecticut, United States, 06520|
|United States, Texas|
|Research Site 4|
|Houston, Texas, United States, 77030|
|United States, Utah|
|Research Site 3|
|Salt Lake City, Utah, United States, 84112|
|Research Site 1|
|Melbourne, Victoria, Australia, 3000|
|Research Site 6|
|Toronto, Ontario, Canada, M5G 2M9|
|Research Site 7|
|Amsterdam, North Holland, Netherlands, 1066|
|Study Director:||Alissa Keegan, MD||CRISPR Therapeutics|
|Responsible Party:||CRISPR Therapeutics AG|
|Other Study ID Numbers:||
|First Posted:||June 18, 2020 Key Record Dates|
|Last Update Posted:||May 11, 2023|
|Last Verified:||May 2023|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Renal cell carcinoma
Renal cell carcinoma with clear cell differentiation
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Male Urogenital Diseases