OncoMatch/Clinical Trials/NCT04775745
Study of Oral Administration of LP-168 in Patients With Relapsed or Refractory B-cell Malignancies.
Is NCT04775745 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments including LP-168 and LP-168 for cll/sll.
Treatment: LP-168 · LP-168 — This is a phase I, multi-center, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and clinical activity of LP-168 in subjects with relapsed or refractory B-cell malignancies. LP-168 is a small molecule inhibitor.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Chronic Lymphocytic Leukemia
Non-Hodgkin Lymphoma
Diffuse Large B-Cell Lymphoma
Prior therapy
Must have received: systemic therapy
Those subjects with WM, FL, MCL, DLBCL, or HCL must have received at least 2 prior systemic therapies
Cannot have received: anti-cancer therapy
Exception: CLL subjects who come off BCR antagonists (BTK inhibitors, PI3K inhibitors, etc.) may have 2-day washout
Any anti-cancer therapy including chemotherapy, biologic or immunotherapy, radiotherapy, etc; Any investigational therapy, including targeted small molecule agents within 14 days or 5 half-lives (whichever is shorter) prior to the first dose of study drug
Cannot have received: hematopoietic stem cell transplantation
autologous/allogeneic hematopoietic stem cell transplantation (HSCT) therapy within 90 days of the first dose of LP-168, or patients on immunosuppressive therapy post-HSCT at the time of Screening, or currently with clinically significant graft-versus-host disease (GVHD)
Lab requirements
Blood counts
ANC ≥1000/uL (exception: if bone marrow heavily infiltrated, may use growth factor to achieve ANC eligibility); Platelet count ≥ 50,000/µL - OR - Platelet count ≥ 20,000/ µL if thrombocytopenia is clearly due to CLL disease under study (per Investigator discretion); Hemoglobin ≥8.0g/dL, and can be achieved by transfusion
Kidney function
Calculated creatinine clearance (CrCl) ≥ 60 mL/min using 24-hour CrCl OR Cockcroft-Gault formula
Liver function
AST and ALT ≤ 1.5 × ULN; Bilirubin ≤ 1.5 × ULN (except Gilbert's Syndrome, who may have a bilirubin > 1.5 × ULN, per discussion between the Investigator and the Medical Monitor)
adequate coagulation, renal, and hepatic function, per local laboratory reference ranges at Screening as follows: APTT and PT not to exceed 1.5 × ULN; CrCl ≥ 60 mL/min; AST and ALT ≤ 1.5 × ULN; Bilirubin ≤ 1.5 × ULN (except Gilbert's Syndrome); ANC ≥1000/uL (exception: if bone marrow heavily infiltrated, may use growth factor); Platelet count ≥ 50,000/µL or ≥ 20,000/ µL if thrombocytopenia due to CLL; Hemoglobin ≥8.0g/dL, can be achieved by transfusion
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Duke Univerisity · Durham, North Carolina
- University of Cincinnati · Cincinnati, Ohio
- Ohio State University · Columbus, Ohio
- Huntsman Cancer Institute, University of Utah · Salt Lake City, Utah
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04775745 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anti-cancer therapy, hematopoietic stem cell transplantation disqualifies patients from enrollment.
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