T Cell Lymphoma Clinical Trial
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
Verified date | May 2024 |
Source | CRISPR Therapeutics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 45 |
Est. completion date | May 2027 |
Est. primary completion date | March 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
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. |
Country | Name | City | State |
---|---|---|---|
Australia | Research Site 3 | Sydney | New South Wales |
Canada | Research Site 7 | Toronto | Ontario |
United States | Research Site 8 | Bronx | New York |
United States | Research Site 2 | Duarte | California |
United States | Research Site 1 | Houston | Texas |
United States | Research Site 4 | Miami | Florida |
United States | Research Site 10 | New Haven | Connecticut |
United States | Research Site 9 | New York | New York |
United States | Research Site 6 | Salt Lake City | Utah |
United States | Research Site 5 | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
CRISPR Therapeutics AG |
United States, Australia, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Part A (dose escalation) | Incidence of adverse events | From CTX130 infusion up to 28 days post-infusion | |
Primary | Part B (cohort expansion) | Objective response rate | From CTX130 infusion up to 60 months post-infusion] | |
Secondary | Progression Free Survival | From date of CTX130 infusion until date of disease progression or death due to any cause, assessed up to 60 months | ||
Secondary | Overall Survival | From date of CTX130 until date of death due to any cause, assessed up to 60 months |
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