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A Safety and Efficacy Study Evaluating CTX130 in Subjects With Relapsed or Refractory T or B Cell Malignancies (COBALT-LYM)
Recruiting
I'm InterestedTrial ID: NCT04502446
Purpose
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.
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
Stanford Investigator(s)
Wen-Kai Weng, MD, PhD
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and, by courtesy, of Dermatology
Eligibility
Inclusion Criteria (abbreviated):
1. Age ≥18 years.
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.
Intervention(s):
biological: CTX130
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Emma Crawford
emma.crawford@stanford.edu