A Safety and Efficacy Study Evaluating CTX110 in Subjects With Relapsed or Refractory B-Cell Mali… (NCT04035434) | Clinical Trial Compass
TerminatedPhase 1/2
A Safety and Efficacy Study Evaluating CTX110 in Subjects With Relapsed or Refractory B-Cell Malignancies (CARBON)
Stopped: Patients to be followed up in the CRSP-ONC-LTF study
United States93 participantsStarted 2019-07-22
Plain-language summary
This is an open-label, multicenter, Phase 1/2 study evaluating the safety and efficacy of CTX110 in subjects with relapsed or refractory B-cell malignancies.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. For NHL patients: Age ≥18 years. For B cell ALL patients: age ≥18 years to ≤70 years
✓. Refractory or relapsed non-Hodgkin lymphoma, as evidenced by 2 or more lines of prior therapy, or histologically confirmed B cell ALL, refractory or relapsed.
✓. Eastern Cooperative Oncology Group performance status 0 or 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 CTX110 infusion.
Exclusion criteria
✕. For NHL patients: prior allogeneic HSCT. For B cell ALL patients: prior allogeneic HSCT within 6 months, and/or any evidence of GvHD.
✕. History of central nervous system (CNS) involvement by malignancy
✕. History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement.
✕. Presence of bacterial, viral, or fungal infection that is uncontrolled.
✕. Positive for HIV, or active hepatitis B virus or hepatitis C virus infection.
✕. Previous or concurrent malignancy, except basal cell or squamous cell skin carcinoma, adequately resected and in situ carcinoma of cervix, or a previous malignancy that was completely resected and has been in remission for ≥5 years.
What they're measuring
1
Dose Escalation Phase 1: Number of Participants With Dose-limiting Toxicities (DLT) in NHL and B Cell ALL Population
Timeframe: Up to 28 days
2
Dose Expansion Phase 1 and Phase 2: Percentage of Participants With Objective Response Rate in NHL Population
✕. For NHL patients: Use of systemic anti-tumor therapy or investigational agent within 14 days or 5 half-lives, whichever is longer, of CTX110 infusion. For B cell ALL patients: Use of systemic antitumor therapy within 7 days of CTX110 infusion.
✕. Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy.