OncoMatch/Clinical Trials/NCT05984147
A Study Evaluating the Safety and Efficacy of AUR108 in Patients With Relapsed Advanced Lymphomas (ASHA-1)
Is NCT05984147 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies AUR108 for relapsed advanced lymphomas.
Treatment: AUR108 — An open-label, first-in-human, Phase 1 study in adult patients with relapsed advanced lymphomas will be done to assess AUR108 safety, tolerability, pharmacokinetics, pharmacodynamics, and optimal biological dose.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Disease stage
Required: Stage III, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: systemic therapy
At a minimum, the patients must have received at least 2 prior lines of systemic therapies. These systemic therapies could be either in the stage II, III or IV.
Cannot have received: systemic anti-cancer therapy (chemotherapy, biological therapy, immunomodulatory drug therapy)
Exception: allowed if >28 days or >5 half-lives from Cycle 1 Day 1
Systemic anti-cancer therapy, such as chemotherapy, or biological therapy, immunomodulatory drug therapy, received within the past 28 days or 5 half-lives, whichever is longer, from the 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
Exception: allowed if >28 days or >5 half-lives from Cycle 1 Day 1
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
Exception: allowed if >28 days from Cycle 1 Day 1
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 ≥ 75,000/μL without transfusion support; Hemoglobin ≥ 9 g/dL (Transfusion is allowed to achieve this Hb)
Kidney function
Creatinine clearance (CrCl) ≥ 30 mL/min (either measured or estimated by the Cockcroft-Gault formula)
Liver function
Total Bilirubin ≤ 1.5 x ULN (≤ 2.5 x ULN if Gilbert's syndrome); AST (SGOT) ≤ 3 x ULN (≤ 5 × ULN if known liver metastases); ALT (SGPT) ≤ 3 x ULN (≤ 5 × ULN if known liver metastases)
Cardiac function
QTc (Bazzett) interval >460 ms on ECG at screening and/or at Cycle 1 Day 1 pre-dose [excluded]
Acceptable bone marrow and organ function at screening as described below: ANC ≥ 1000/μL (without WBC growth factor support); Platelet count ≥ 75,000/μL without 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) ≥ 30 mL/min (either measured or estimated by the Cockcroft-Gault formula). QTc (Bazzett) interval >460 ms on ECG at screening and/or at Cycle 1 Day 1 pre-dose [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05984147 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic anti-cancer therapy (chemotherapy, biological therapy, immunomodulatory drug therapy), definitive radiotherapy, investigational agent disqualifies patients from enrollment.
What disease stage is eligible?
Stage III or IV is required.
Is there an age limit?
Yes. Patients must be 99 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify