Back to resultsA Safety and Efficacy Study Evaluating CTX130 in Subjects With Relapsed or Refractory T or B Cell Malignancies (COBALT-LYM)
Primary Purpose
T Cell Lymphoma
Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
CTX130
Sponsored by
About this trial
This is an interventional treatment trial for T Cell Lymphoma focused on measuring CAR T, Allogeneic, Lymphoma
Eligibility Criteria
Inclusion Criteria (abbreviated):
- Age ≥18 years.
- Confirmed diagnosis of a T cell malignancy or Diffuse Large B-Cell Lymphoma (DLBCL).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- 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.
Exclusion Criteria (abbreviated):
- Prior allogeneic stem cell transplant (SCT).
- Prior treatment with any anti-CD70 targeting agents.
- 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.
- Pregnant or breastfeeding females.
Sites / Locations
- Research Site 2Recruiting
- Research Site 5Recruiting
- Research Site 10Recruiting
- Research Site 4Recruiting
- Research Site 8Recruiting
- Research Site 9Recruiting
- Research Site 1Recruiting
- Research Site 6Recruiting
- Research Site 3Recruiting
- Research Site 7Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CTX130
Arm Description
Administered by IV infusion following lymphodepleting chemotherapy.
Outcomes
Primary Outcome Measures
Part A (dose escalation)
Incidence of adverse events
Part B (cohort expansion)
Objective response rate
Secondary Outcome Measures
Progression Free Survival
Overall Survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04502446
Brief Title
A Safety and Efficacy Study Evaluating CTX130 in Subjects With Relapsed or Refractory T or B Cell Malignancies (COBALT-LYM)
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 31, 2020 (Actual)
Primary Completion Date
March 2027 (Anticipated)
Study Completion Date
May 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CRISPR Therapeutics AG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
The study may enroll approximately 45 subjects in total.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
T Cell Lymphoma
Keywords
CAR T, Allogeneic, Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CTX130
Arm Type
Experimental
Arm Description
Administered by IV infusion following lymphodepleting chemotherapy.
Intervention Type
Biological
Intervention Name(s)
CTX130
Intervention Description
CTX130 CD70-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components.
Primary Outcome Measure Information:
Title
Part A (dose escalation)
Description
Incidence of adverse events
Time Frame
From CTX130 infusion up to 28 days post-infusion
Title
Part B (cohort expansion)
Description
Objective response rate
Time Frame
From CTX130 infusion up to 60 months post-infusion]
Secondary Outcome Measure Information:
Title
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
Title
Overall Survival
Time Frame
From date of CTX130 until date of death due to any cause, assessed up to 60 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria (abbreviated):
Age ≥18 years.
Confirmed diagnosis of a T cell malignancy or Diffuse Large B-Cell Lymphoma (DLBCL).
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
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.
Exclusion Criteria (abbreviated):
Prior allogeneic stem cell transplant (SCT).
Prior treatment with any anti-CD70 targeting agents.
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.
Pregnant or breastfeeding females.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Trials
Phone
+1 (877) 214-4634
Email
MedicalAffairs@crisprtx.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alissa Keegan, PhD
Organizational Affiliation
CRISPR Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Research Site 2
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 5
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 10
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 4
City
Miami
State/Province
Florida
ZIP/Postal Code
33124
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 8
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 9
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 1
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 6
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 3
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Individual Site Status
Recruiting
Facility Name
Research Site 7
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C1
Country
Canada
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Safety and Efficacy Study Evaluating CTX130 in Subjects With Relapsed or Refractory T or B Cell Malignancies (COBALT-LYM)
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