OncoMatch/Clinical Trials/NCT06761586
A Study of AUR104 in Patients With Relapsed/Refractory Lymphoid Malignancies (VIJAY-1)
Is NCT06761586 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies AUR104 for select relapsed/refractory lymphoid malignancies.
Treatment: AUR104 — This is a multicenter, open-label, Phase 1 study of AUR104 in adult patients with select Relapsed/Refractory (R/R) Lymphoid Malignancies. The main objective of the study is to evaluate the safety and tolerability of the study drug AUR104.In this study, safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of AUR104 will be evaluated in dose escalation manner.
Check if I qualifyExtracted eligibility criteria
Disease stage
Required: Stage III, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic therapy
patients must have relapsed or refractory disease to at least 2 prior lines of systemic therapies for NHL or CLL, or Hodgkin's disease
Cannot have received: systemic anti-cancer therapy
Exception: low-dose prednisone (up to 10 mg/day) is allowed
Systemic anti-cancer therapy, such as chemotherapy, biological therapy, or immunomodulatory drug therapy, received within the past 28 days or 5 half-lives, whichever is longer, from Cycle 1 Day 1 of the study.
Cannot have received: definitive radiotherapy
Exception: limited field palliative radiation is allowed
Definitive Radiotherapy within the last 21 days of Cycle 1 Day 1 (limited field palliative radiation is allowed and no restrictions during the screening period or during the trial).
Cannot have received: investigational agent
Use of any investigational agent within 28 days or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1.
Cannot have received: major surgery
Major surgery ≤ 28 days from Cycle 1 Day 1 (major surgery is defined as a procedure requiring general anesthesia)
Lab requirements
Blood counts
ANC ≥ 1000/μL (without WBC growth factor support). Platelet count: For patients with CLL ≥ 50,000/μL, For patients with lymphomas ≥ 75,000/μL without bone marrow involvement and ≥ 50,000/μL with bone marrow involvement. These thresholds should be qualified without current transfusion support. Hemoglobin ≥ 9 g/dL (Transfusion is allowed to achieve this Hb).
Kidney function
Creatinine clearance (CrCl) ≥ 60 mL/min (either measured or estimated by the Cockcroft-Gault formula).
Liver function
Total Bilirubin ≤ 1.5 x ULN (Patients with known Gilbert's syndrome are allowed with a Total Bilirubin ≤ 2.5 x ULN). AST (SGOT) ≤ 3 x ULN (≤ 5 × ULN if known liver metastases). ALT (SGPT) ≤ 3 x ULN (≤ 5 × ULN if known liver metastases).
Cardiac function
Mean Heart Rate less than 60 at screening or Cycle 1 Day 1 (to be recorded at least 3 times at least 5 minutes apart) in ECG [excluded]. Left ventricular ejection fraction (LVEF) less than 50% as determined by an echocardiogram (ECHO) or Multigated Acquisition (MUGA) scan [excluded]. QTcF (Fridericia) interval more than 450 ms for patients on ECG at screening and/or at Cycle 1 Day 1 [excluded]. Uncontrolled arterial hypertension defined as supine SBP of ≥ 140 mm Hg AND/OR supine DBP ≥ 90 mmHg on stable doses of three or lesser different classes of antihypertensive drugs [excluded]. Patients taking 4 or more classes of antihypertensives are excluded.
Acceptable bone marrow and organ function at screening as described below: * ANC ≥ 1000/μL (without WBC growth factor support) * Platelet count: For patients with CLL ≥ 50,000/μL, For patients with lymphomas ≥ 75,000/μL without bone marrow involvement and ≥ 50,000/μL with bone marrow involvement. These thresholds should be qualified without current transfusion support. * Hemoglobin ≥ 9 g/dL (Transfusion is allowed to achieve this Hb). * Total Bilirubin ≤ 1.5 x ULN (Patients with known Gilbert's syndrome are allowed with a Total Bilirubin ≤ 2.5 x ULN). * AST (SGOT) ≤ 3 x ULN (≤ 5 × ULN if known liver metastases). * ALT (SGPT) ≤ 3 x ULN (≤ 5 × ULN if known liver metastases). * Creatinine clearance (CrCl) ≥ 60 mL/min (either measured or estimated by the Cockcroft-Gault formula).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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