A Safety and Efficacy Study Evaluating CTX130 in Subjects With Relapsed or Refractory T or B Cell Malignancies (COBALT-LYM)
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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
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.
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
T Cell Lymphoma
Age (in years)
18+
Phase
Phase 1
Participants needed
45
Est. Completion Date
May 31, 2027
Treatment type
Interventional
Sponsor
CRISPR Therapeutics
ClinicalTrials.gov identifier
NCT04502446
Study number
CRSP-ONC-004
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