OncoMatch/Clinical Trials/NCT04807881
Phase Ib Clinical Study of Keynatinib
Is NCT04807881 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies Keynatinib for lymphoma, b-cell.
Treatment: Keynatinib — The purpose of this study is to evaluate the efficacy, safety, PK characteristics in subjects with relapsed/refractory B-cell lymphoma. Furthermore, the relationship between the exposure level of Keynatinib and its efficacy and safety, the penetration rate of keynatinib in the Blood-Brain Barrier (BBB) and its PK characteristics in cerebrospinal fluid in R/R-PCNSL patients, the relationship between the BTK receptor occupancy rate and the efficacy are also evaluated.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CCND1 high expression (high)
cyclin D1 highly expressed by immunohistochemistry
Required: IGH t(11;14)(q13;q32)
t (11; 14) (q13; q32) positive by cytogenetic test
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic therapy — Cohort 1: at least first line treatment to CNS lesions; Cohort 2: at least first-line systemic treatment (≥2 cycles); Cohort 3: >1 but ≤3 different chemotherapies and/or targeted drugs
relapsed or refractory...at least first line treatment must be given to CNS lesions; relapsed or refractory CLL/SLL that previously received at least first-line systemic treatment; pretreated with >1 but failed in ≤3 different chemotherapies and/or targeted drugs treatment
Cannot have received: BTK inhibitor
Have previously received the treatment of B Cell Receptor (BCR) inhibitors (such as BTK, phosphoinositide kinase 3 kinase [PI3K] or SYK inhibitors)
Cannot have received: PI3K inhibitor
Have previously received the treatment of B Cell Receptor (BCR) inhibitors (such as BTK, phosphoinositide kinase 3 kinase [PI3K] or SYK inhibitors)
Cannot have received: SYK inhibitor
Have previously received the treatment of B Cell Receptor (BCR) inhibitors (such as BTK, phosphoinositide kinase 3 kinase [PI3K] or SYK inhibitors)
Cannot have received: BCL-2 inhibitor (ABT-199)
BCL-2 inhibitors (such as ABT-199)
Cannot have received: CAR-T cell therapy
Chimeric Antigen Receptor T-Cell Immunotherapy (CAR-T)
Cannot have received: bispecific antibody
bispecific antibody drug
Cannot have received: allogeneic hematopoietic stem cell transplant
Exception: except for those who have received ASCT more than six months
Allogenetic Haematopoietic Stem Cell Transplantation (Allo-HSCT) or other organ transplants (except for those who have received ASCT more than six months)
Cannot have received: autologous hematopoietic stem cell transplant
Exception: allowed if >6 months prior
autologous hematopoietic stem cell transplantation within the past 6 months
Lab requirements
Blood counts
Neutrophil absolute value ≥ 1.0 (cohort 1), 0.75 (cohort 2/3) ×10^9/L; platelet ≥ 75 (cohort 1), 50 (cohort 2/3), 30×10^9/L acceptable if CLL patients have bone marrow involvement; hemoglobin ≥ 80 g/L (cohort 1); no blood transfusion/hematopoietic stimulating factor within 21 days (7 days in cohort 2/3)
Kidney function
serum creatinine ≤ 2 × ULN or creatinine clearance rate ≥ 50 ml / min (Cockcroft Gault)
Liver function
Total bilirubin (TBIL) ≤ 2 × ULN (unless diagnosed as Gilbert syndrome), AST and ALT ≤ 2.5 × ULN
Cardiac function
LVEF ≥ 50%; no NYHA II or higher heart failure, no unstable angina, no recent MI, no arrhythmia requiring treatment, no primary cardiomyopathy, no QTc >470 ms (female) or >450 ms (male)
Subjects have appropriate organ functions, the main organ functions meet the following criteria: ... see above
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT04807881 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior BTK inhibitor, PI3K inhibitor, SYK inhibitor disqualifies patients from enrollment.
Does this trial require CCND1?
Yes, CCND1 high expression is a required biomarker for enrollment.
Does this trial require IGH?
Yes, IGH t(11;14)(q13;q32) is a required biomarker for 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 qualifyRelated pages