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A Safety and Efficacy Study Evaluating CTX131 in Adult Subjects With Relapsed or Refractory Solid Tumors

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ClinicalTrials.gov Identifier: NCT05795595
Recruitment Status : Recruiting
First Posted : April 3, 2023
Last Update Posted : April 2, 2024
Sponsor:
Information provided by (Responsible Party):
CRISPR Therapeutics ( CRISPR Therapeutics AG )

Study Description
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Brief Summary:
This is an open-label, multicenter, Phase 1/2 study evaluating the safety and efficacy of CTX131™ in subjects with relapsed or refractory solid tumors.

Condition or disease Intervention/treatment Phase
Clear Cell Renal Cell Carcinoma Cervical Carcinoma Esophageal Carcinoma Pancreatic Adenocarcinoma Malignant Pleural Mesothelioma Biological: CTX131 Phase 1 Phase 2

Detailed Description:
An open-label, multi-center Phase 1/2 study of CTX131 in subjects with relapsed/refractory solid tumors. CTX131 is an is allogeneic CD70- directed chimeric antigen receptor (CAR) T cell immunotherapy comprised of allogeneic T cells that are genetically modified ex vivo using CRISPR-Cas9 (clustered regularly interspaced short palindromic repeats/ CRISPR associated protein 9) gene editing components (single guide RNA and Cas9 nuclease).
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2, Open-label, Multicenter, Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of Anti-CD70 Allogeneic CRISPR-Cas9-Engineered T Cells (CTX131) in Adult Subjects With Relapsed or Refractory Solid Tumors
Actual Study Start Date : March 13, 2023
Estimated Primary Completion Date : April 2030
Estimated Study Completion Date : May 2030

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: CTX131
Administered by IV infusion following lymphodepleting chemotherapy.
 Biological: CTX131
CTX131 (CD70-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components)


Outcome Measures
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Primary Outcome Measures :
  1. Phase 1 (Dose Escalation): Incidence of adverse events [ Time Frame: From CTX131 infusion up to 28 days post-infusion ]
    Defined as dose-limiting toxicities

  2. Phase 2 (Cohort Expansion): Objective response rate (ORR) [ Time Frame: From CTX131 infusion up to 60 months post-infusion ]
    ORR based on Independent Review Committee (IRC) assessment, defined as the proportion of subjects who have achieved a best overall response of CR or PR according to appropriate response evaluation criteria for each disease histology


Eligibility Criteria
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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

Key Inclusion Criteria:

  1. Age ≥18 years.
  2. Unresectable or metastatic, relapsed/refractory, clear cell renal cell carcinoma, cervical carcinoma, pancreatic adenocarcinoma, endometrial carcinoma, and malignant pleural mesothelioma.
  3. Eastern Cooperative Oncology Group performance status 0 or 1.
  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 CTX131 infusion.

Key Exclusion Criteria:

  1. Prior treatment with anti-CD70 targeting agents
  2. History of certain central nervous system (CNS), cardiac or pulmonary conditions.
  3. Presence of uncontrolled bacterial, viral, or fungal infection.
  4. Active HIV, hepatitis B virus or hepatitis C virus infection.
  5. Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy.
  6. Women who are pregnant or breastfeeding.
Contacts and Locations
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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): NCT05795595


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

Locations
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United States, California
Research Site 3 Recruiting
Duarte, California, United States, 91010
United States, Illinois
Research Site 7 Recruiting
Chicago, Illinois, United States, 60637
United States, Massachusetts
Research Site 6 Recruiting
Boston, Massachusetts, United States, 02215
United States, Missouri
Research Site 2 Recruiting
Saint Louis, Missouri, United States, 63110
United States, North Carolina
Research Site 4 Recruiting
Durham, North Carolina, United States, 27710
United States, Tennessee
Research Site 1 Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
Research Site 5 Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
CRISPR Therapeutics AG
Investigators
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Study Director: Alissa Keegan, MD, PhD CRISPR Therapeutics
More Information
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Responsible Party: CRISPR Therapeutics AG
ClinicalTrials.gov Identifier: NCT05795595    
Other Study ID Numbers: CRSP-ONC-005
First Posted: April 3, 2023    Key Record Dates
Last Update Posted: April 2, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Carcinoma
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Mesothelioma
Mesothelioma, Malignant
Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
 Urogenital Diseases
Kidney Diseases
Urologic Diseases
Male Urogenital Diseases
Adenoma
Neoplasms, Mesothelial
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Pleural Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Head and Neck Neoplasms