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

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

Principal Investigator

Amer Beitinjaneh

Enrollment Status

Closed

Clinical Trial ID

Institutional Protocol # 20200606
National Clinical Trials Identifier NCT04502446

Clinical Trial 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.


Phase

Phase 1


Funding Agency/Sponsor

Industrial


Disease

Lymphoma


Enrollment 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.


Contact Information

Phone Number 305-243-2647
Get detailed information on ClinicalTrials.Gov

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