NCT06453902 TGRX-678 Chinese Phase II in Chronic Myelogenous Leukemia (CML) Patients
| NCT ID | NCT06453902 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Shenzhen TargetRx Co., Ltd. |
| Condition | Chronic Myeloid Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-07-15 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 40 participants in total. It began in 2024-07-15 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
Inclusion Criteria: * Willing to consent * 18 years of age or above at time of screening; both sexes eligible * Relapsed or refactory from 3rd-generation Tyrosine kinase inhibitor (TKI) treatment * For patients without T315I mutation, the patients must received 1st, 2nd and 3rd generation TKI * For patients with T315I mutation, the patients much received Olverembatinib or Ponatinib treatment * Diagnosis of CML-AP by bone marrow morphological test, molecular biology test or cytogenetic tests * ECOG score \</=2 * Minimum life expectancy of at least 3 months * Adequate hematological indicators * Adequate kidney function * Adequate liver function * Adequate coagulation function * Adequate pancreatic function * Adequate QTc interval as confirmed by electrocardiogram (ECG) test * Negative pregnancy result at screening for female patients of child-bearing potential * Willing to take contraceptive measure during the study (For male and female patients of child-bearing potential) Exclusion Criteria: * Reception of TKI treatment or presence of unrecovered TKI treatment related non-hematological adverse events within 7 days of first dose * Reception of other anti-tumor treatments * In need for immune suppressive treatment * Usage of drugs associated with Torsades de Pointes within 1 months before screening * Presence of other medical conditions that require using treatment that may have drug-drug interaction with the investigational drug * History of hemapoietic stem cell transplant * Presence of active central nervous system conditions * CML-AP patients who already reached major hematological response * CML-AP patients who used to progress to Blast Phase (BP) * Presence or having uncontrolled condition for cardiovascular diseases * History of any heart or cardiovascular conditions (except for patients with hypertension which is controlled by anti-hypertensive drugs, and blood pressure is controlled at no higher than 160/100 mmHg for 1 months before screening) * Usage of any Traditional Chinese Medicine indicated for anti-tumor purpose 2 weeks before first dose * Severe hemorrhagic disease unrelated to CML * History of severe cardiovascular condition during past TKI treatment for CML * History of pancreatic inflammation or alcohol abuse within 3 years before first dose * Uncontrolled Hypertriglyceridemia * Presence of malabsorption or other conditions that may affect drug absorption * Diagnosis of other primary malignant tumor within 5 years * Reception of major surgery 14 days before first dose * Presence of continuous or active infection (including HIV, hepatitis B, hepatitis C) * Presence of other conditions that the investigators or medical monitor deem unfit for the study
Contact & Investigator
Qian Jiang, MD
PRINCIPAL INVESTIGATOR
Peking University People's Hospital
Frequently Asked Questions
Who can join the NCT06453902 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Myeloid Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06453902 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06453902 currently recruiting?
Yes, NCT06453902 is actively recruiting participants. Contact the research team at yingkun.lv@tjrbiosciences.com for enrollment information.
Where is the NCT06453902 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06453902 clinical trial?
NCT06453902 is sponsored by Shenzhen TargetRx Co., Ltd.. The principal investigator is Qian Jiang, MD at Peking University People's Hospital. The trial plans to enroll 40 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.