Status:
TERMINATED
A Safety and Efficacy Study Evaluating CTX130 in Subjects With Relapsed or Refractory T or B Cell Malignancies (COBALT-LYM)
Lead Sponsor:
CRISPR Therapeutics AG
Conditions:
T Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
July 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2024
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT04502446
Start Date
July 31 2020
End Date
August 30 2024
Last Update
January 8 2025
Active Locations (10)
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1
Research Site 2
Duarte, California, United States, 91010
2
Research Site 5
Stanford, California, United States, 94305
3
Research Site 10
New Haven, Connecticut, United States, 06520
4
Research Site 4
Miami, Florida, United States, 33124