OncoMatch/Clinical Trials/NCT04807881
Phase Ib Clinical Study of Keynatinib
Is NCT04807881 recruiting? Yes, currently enrolling (May 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
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.
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