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

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ClinicalTrials.gov Identifier: NCT04438083
Recruitment Status : Recruiting
First Posted : June 18, 2020
Last Update Posted : May 14, 2021
Sponsor:
Information provided by (Responsible Party):
CRISPR Therapeutics ( CRISPR Therapeutics AG )

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.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Biological: CTX130 Phase 1

Detailed Description:
The study may enroll approximately 107subjects in total.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 107 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Experimental: CTX130
Administered by IV infusion following lymphodepleting chemotherapy.
Biological: CTX130
CTX130 CD70-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components.




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  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 ]
  2. 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
Criteria

Abbreviated Inclusion Criteria:

  1. Age ≥18 years and body weight ≥60 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.

Information from the National Library of Medicine

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


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

Locations
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United States, California
Research Site 2 Recruiting
Duarte, California, United States, 91010
United States, Connecticut
Research Site 5 Recruiting
Hartford, Connecticut, United States, 06520
United States, Texas
Research Site 4 Recruiting
Houston, Texas, United States, 77030
United States, Utah
Research Site 3 Recruiting
Salt Lake City, Utah, United States, 84112
Australia, Victoria
Research Site 1 Recruiting
Melbourne, Victoria, Australia, 3000
Canada, Ontario
Research Site 6 Recruiting
Toronto, Ontario, Canada, M5G 2M9
Netherlands
Research Site 7 Recruiting
Amsterdam, North Holland, Netherlands, 1066
Sponsors and Collaborators
CRISPR Therapeutics AG
Investigators
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Study Director: Matthias Will, MD CRISPR Therapeutics
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Responsible Party: CRISPR Therapeutics AG
ClinicalTrials.gov Identifier: NCT04438083    
Other Study ID Numbers: CRSP-ONC-003
First Posted: June 18, 2020    Key Record Dates
Last Update Posted: May 14, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CRISPR Therapeutics ( CRISPR Therapeutics AG ):
CAR T
Allogeneic
Renal cell carcinoma
Renal cell carcinoma with clear cell differentiation
CRISPR-Cas9
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases