Phase
Condition
Lymphoma, B-cell
Lymphoma
Treatment
ATG-031
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Histological or cytologically confirmed advanced solid tumor or B-NHL which haverelapsed from or been refractory to all locally available standard therapies.
Adequate hepatic function:
AST and ALT ≤ 2.5×times ULN (≤ 5 × ULN if liver metastases).
Total bilirubin ≤ 1.5×ULN (except Gilbert syndrome).
Lipase and amylase ≤ 2×ULN.
Adequate renal function: calculated creatinine clearance of ≥ 40 mL/min using theCockroft- Gault formula.
Adequate bone marrow function without growth factors or blood transfusion within 7days of the first dose of study treatment.
Absolute neutrophil count (ANC) ≥ 1.5×109/L.
Platelet count ≥ 100×109/L.
Hemoglobin ≥ 90 g/L.
Exclusion
Key Exclusion Criteria:
Patients with CNS malignancies, except those who are clinically stable for ≥ 4 weeksand off corticosteroids following prior surgery, whole-brain radiation, orstereotactic radiosurgery.
Received any other investigational product or prior systemic anticancer therapyincluding chemotherapy, immunotherapy, radiotherapy, or other anticancer within 21days prior to first dose of study
Grade ≥3 irAEs or irAEs that lead to discontinuation of prior immunotherapy.8. Otherprimary malignancies developed within 5 years prior to the first dose of the studytreatment
Other primary malignancies developed within 5 years prior to the first dose of thestudy treatment
Have active or previous autoimmune diseases that are likely to recur or are at riskof such diseases judged by the investigator.
Major cardiovascular disease
Active hepatitis B and/or hepatitis C (HBV-DNA or HCV-RNA detectable by locallaboratory, respectively).
Patients with history of human immunodeficiency virus (HIV) infection or acquiredimmunodeficiency syndrome (AIDS).
A history of allograft organ transplantation for solid tumor or allogeneichematopoietic stem cell transplantation for B-NHL patients).
Patients who are pregnant or lactating.
Study Design
Study Description
Connect with a study center
University of California San Francisco (UCSF)
San Francisco, California 94102
United StatesActive - Recruiting
Regents of the University of Colorado
Aurora, Colorado 80045
United StatesActive - Recruiting
Yale University
New Haven, Connecticut 06520- 8087
United StatesActive - Recruiting
University of Texas M.D. Anderson Cancer Center
Houston, Texas 77030
United StatesActive - Recruiting

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