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A Safety and Efficacy Study Evaluating CTX130 in Subjects With Relapsed or Refractory T or B Cell Malignancies (COBALT-LYM)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04502446
Recruitment Status : Recruiting
First Posted : August 6, 2020
Last Update Posted : July 15, 2021
Sponsor:
Information provided by (Responsible Party):
CRISPR Therapeutics ( CRISPR Therapeutics AG )

Study Description
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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 T or B cell malignancies.

Condition or disease Intervention/treatment Phase
T Cell Lymphoma Biological: CTX130 Phase 1

Detailed Description:
The study may enroll approximately 45 subjects in total.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label, Multicenter, Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of Anti-CD70 Allogeneic CRISPR-Cas9-Engineered T Cells (CTX130) in Subjects With Relapsed or Refractory T or B Cell Malignancies
Actual Study Start Date : July 31, 2020
Estimated Primary Completion Date : March 2027
Estimated Study Completion Date : May 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Part A (dose escalation) [ Time Frame: From CTX130 infusion up to 28 days post-infusion ]
    Incidence of adverse events

  2. Part B (cohort expansion) [ Time Frame: From CTX130 infusion up to 60 months post-infusion] ]
    Objective response rate


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 ]

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

Inclusion Criteria (abbreviated):

  1. Age ≥18 years and body weight ≥60 kg.
  2. Confirmed diagnosis of a T cell malignancy or Diffuse Large B-Cell Lymphoma (DLBCL).
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  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 CTX130 infusion.

Exclusion Criteria (abbreviated):

  1. Prior allogeneic stem cell transplant (SCT).
  2. Prior treatment with any anti-CD70 targeting agents.
  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.
  8. Pregnant or breastfeeding females.
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): NCT04502446


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
Research Site 5 Recruiting
Stanford, California, United States, 94305
United States, Connecticut
Research Site 10 Recruiting
New Haven, Connecticut, United States, 06520
United States, Florida
Research Site 4 Recruiting
Miami, Florida, United States, 33124
United States, New York
Research Site 8 Recruiting
Bronx, New York, United States, 10467
Research Site 9 Recruiting
New York, New York, United States, 10065
United States, Texas
Research Site 1 Recruiting
Houston, Texas, United States, 77030
United States, Utah
Research Site 6 Recruiting
Salt Lake City, Utah, United States, 84112
Australia, New South Wales
Research Site 3 Recruiting
Sydney, New South Wales, Australia, 2050
Canada, Ontario
Research Site 7 Recruiting
Toronto, Ontario, Canada, M5G 2C1
Sponsors and Collaborators
CRISPR Therapeutics AG
Investigators
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Study Director: Matthias Will, MD CRISPR Therapeutics
More Information
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Responsible Party: CRISPR Therapeutics AG
ClinicalTrials.gov Identifier: NCT04502446    
Other Study ID Numbers: CRSP-ONC-004
First Posted: August 6, 2020    Key Record Dates
Last Update Posted: July 15, 2021
Last Verified: July 2021
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
Lymphoma
Additional relevant MeSH terms:
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Lymphoma, T-Cell
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin