A Safety and Efficacy Study Evaluating CTX131 in Adult Subjects With Relapsed/Refractory Hematolo… (NCT06492304) | Clinical Trial Compass
CompletedPhase 1/2
A Safety and Efficacy Study Evaluating CTX131 in Adult Subjects With Relapsed/Refractory Hematologic Malignancies
United States12 participantsStarted 2024-08-13
Plain-language summary
This is an open label, multicenter, phase 1/2 dose evaluation and cohort expansion study evaluating the safety and efficacy of CTX131 in subjects with Relapsed/Refractory Hematologic Malignancies
Who can participate
Age range18 Years – 100 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. ≥18 years of age
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (ECOG status of 2 will be permitted for subjects with AML)
✓. Adequate renal, liver, cardiac and pulmonary organ function
✓. Females of childbearing potential and male subjects must agree to use an acceptable, highly effective method of contraception (as specified in the protocol) from enrollment through at least 12 months after last CTX131 infusion
Exclusion criteria
✕. Prior treatment with anti-CD70 targeting agents
✕. Active CNS manifestation of underlying disease
✕. History or presence of clinically relevant CNS pathology such as seizure, stroke, severe brain injury, cerebellar disease, myelopathy, history of posterior reversible encephalopathy syndrome with prior therapy, or another condition that in opinion of investigator may increase CAR T-related toxicities
✕
What they're measuring
1
Phase 1 Part A (dose escalation) and Part B (dose optimization in selected disease types):
Timeframe: From CTX131 infusion up to 28 days post-infusion
2
Objective Response rate (ORR)
Timeframe: From CTX131 infusion up to 60 months post-infusion
3
Composite Complete Remission (CRc)
Timeframe: From CTX131 infusion up to 60 months post-infusion
. Uncontrolled bacterial, viral, or fungal infection
✕. Positive for HIV, or active hepatitis B virus or hepatitis C virus infection.
✕. Concurrent systemic treatment with an anticancer biologic (e.g., monoclonal antibody) within 30 days prior to CTX131 infusion or with a non-biological anticancer drug within 14 days prior to CTX131 infusion. Mogamulizumab treatment is prohibited 50 days prior to CTX131 infusion.
✕. Diagnosis with another invasive malignancy in the last 5 years with the exception of non- melanoma skin cancer and malignancies deemed by the investigator and medical monitor to be of low likelihood for recurrence
✕. Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy.