OncoMatch/Clinical Trials/NCT06453902
TGRX-678 Chinese Phase II in Chronic Myelogenous Leukemia (CML) Patients
Is NCT06453902 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies TGRX-678 for chronic myeloid leukemia.
Treatment: TGRX-678 — A Phase II study evaluating the safety and efficacy of TGRX-678 in Chronic Myelogenous Leukemia (CML) patients in Accelerated phase (AP) and are relapsed or refractory from third-generation Tyrosine Kinase Inhibitor (TKI) treatment
Check if I qualifyExtracted eligibility criteria
Cancer type
Chronic Myeloid Leukemia
Biomarker criteria
Required: BCR fusion
Diagnosis of CML-AP by bone marrow morphological test, molecular biology test or cytogenetic tests
Required: ABL1 fusion
Diagnosis of CML-AP by bone marrow morphological test, molecular biology test or cytogenetic tests
Allowed: ABL1 T315I
For patients with T315I mutation, the patients much received Olverembatinib or Ponatinib treatment
Disease stage
Required: Stage ACCELERATED PHASE
Excluded: Stage BLAST PHASE
Diagnosis of CML-AP by bone marrow morphological test, molecular biology test or cytogenetic tests; CML-AP patients who used to progress to Blast Phase (BP) [excluded]
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: third-generation tyrosine kinase inhibitor
Relapsed or refactory from 3rd-generation Tyrosine kinase inhibitor (TKI) treatment
Must have received: first-generation tyrosine kinase inhibitor
For patients without T315I mutation, the patients must received 1st, 2nd and 3rd generation TKI
Must have received: second-generation tyrosine kinase inhibitor
For patients without T315I mutation, the patients must received 1st, 2nd and 3rd generation TKI
Must have received: third-generation tyrosine kinase inhibitor
For patients without T315I mutation, the patients must received 1st, 2nd and 3rd generation TKI
Must have received: tyrosine kinase inhibitor (Olverembatinib, Ponatinib)
For patients with T315I mutation, the patients much received Olverembatinib or Ponatinib treatment
Cannot have received: tyrosine kinase inhibitor
Reception of TKI treatment or presence of unrecovered TKI treatment related non-hematological adverse events within 7 days of first dose
Cannot have received: other anti-tumor treatments
Reception of other anti-tumor treatments
Cannot have received: hematopoietic stem cell transplant
History of hemapoietic stem cell transplant
Cannot have received: Traditional Chinese Medicine indicated for anti-tumor purpose
Usage of any Traditional Chinese Medicine indicated for anti-tumor purpose 2 weeks before first dose
Lab requirements
Blood counts
adequate hematological indicators
Kidney function
adequate kidney function
Liver function
adequate liver function
Cardiac function
adequate qtc interval as confirmed by electrocardiogram (ecg) test
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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