Evaluating TGRX-814 in patients with blood cancers

A Single-arm, Open-label, Dose Escalation and Expansion Phase I/II Study Evaluating Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TGRX-814 Monotherapy and Combination Therapy in Patients With Hematological Malignancies

This study is testing a new drug called TGRX-814 to see if it is safe and effective for people with blood cancers like lymphoma and leukemia.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shenzhen TargetRx Co., Ltd. (Industry-sponsored)
• Drugs / interventions: CAR-T
• Locations: 1 site (Tianjin, Tianjin Municipality)
• Trial ID: NCT06206174 on ClinicalTrials.gov

What this trial studies

This is a single-arm, open-label phase I/II study designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of TGRX-814 in patients diagnosed with hematological malignancies such as non-Hodgkin lymphoma, acute myeloid leukemia, acute lymphoblastic leukemia, and myelodysplastic syndromes. The study will involve a dose escalation and expansion approach to determine the maximum tolerated dose and recommended phase II dose of TGRX-814. Participants will receive TGRX-814 as monotherapy and in combination with other therapies, with a focus on evaluating its safety and efficacy profiles. This first-in-human trial aims to provide critical data on the drug's performance in this patient population.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of non-Hodgkin lymphoma, acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndromes.

Not a fit: Patients with other types of cancer or those who do not meet the specific eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a new treatment option for patients with hematological malignancies.

How similar studies have performed: While this approach is novel for TGRX-814, similar studies have shown promise in evaluating new therapies for hematological malignancies.

Eligibility criteria

Inclusion Criteria:

1. male or female ≥ 18 years of age
2. fully understand the requirements of the study and voluntarily sign a written informed consent form
3. diagnosis of NHL, ALL, AML or MDS
4. Eastern Cooperative Oncology Group (ECOG) physical status score ≤ 2
5. adequate bone marrow function
6. patients at high risk for Tumor Lysis Syndrome (TLS) determined by investigator and sponsor for agreement to enroll
7. adequate disease indicator
8. adequate coagulation, hepatic and renal function
9. female subjects of childbearing potential and male subjects whose partners are women of childbearing potential must agree to use a medically approved highly effective contraceptive from the time of signing the Informed Consent Form until at least 3 months after the last dose of study drug; women of childbearing potential must have a negative blood or urine pregnancy test within 7 days prior to the first dose of study drug
10. Expected survival time ≥ 12 weeks

Exclusion Criteria:

1. received BCL-2 inhibitor therapy prior to the first dose of study drug, unless discontinued due to intolerance
2. subjects with NHL have been diagnosed with Burkitt's lymphoma, lymphoblastoid lymphoma/leukemia, or post-transplant lymphoproliferative disease (PTLD)
3. AML subjects with a diagnosis of acute promyelocytic leukemia or Ph chromosome positive or persistent extramedullary leukemia
4. tumor infiltration of the central nervous system
5. received allogeneic hematopoietic stem cell transplantation; or received autologous hematopoietic stem cell transplantation within 3 months
6. received vaccination within 4 weeks prior to first dose or scheduled to be vaccinated during the study
7. HBsAg-positive or HBcAb-positive; HCV antibody-positive; HIV antibody-positive
8. monoclonal antibody antitumor therapy within 4 weeks prior to the first dose; participation in a clinical trial of another interventional drug within 4 weeks prior to the first dose; participation in CAR-T therapy within 12 weeks prior to the first dose; 9. 14 weeks prior to the first dose
9. received anticancer therapy/investigational therapy within 14 days prior to the first dose, or has not recovered from clinically significant toxicity below grade 2 on prior therapy
10. received steroidal anticancer therapy, CYP3A inhibitors, or CYP3A inducers within 7 days prior to the first dose of study drug
11. consumption of grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges), or popcorn within 3 days prior to the first dose of the drug
12. poorly controlled hypertension; left ventricular ejection fraction ≤ 50% as assessed by cardiac ultrasound; prolonged QT interval; Grade III atrioventricular block or other arrhythmia requiring medical intervention; New York Heart Association (NYHA) Class III or IV congestive heart failure; had myocardial infarction or experienced bypass surgery within 6 months prior to dosing; had arterial or venous thrombotic events within 6 months prior to the first dose of study drug; have other cardiovascular diseases that investigator deemed unfit for enrollment
13. having a history of renal, neurological, psychiatric, pulmonary, endocrine, metabolic, immunologic, cardiovascular, or hepatic disease that, in the opinion of the Investigator, would adversely affect the subject's participation in this study
14. having a history of active malignancy other than NHL, AML, or MDS within 3 years prior to participation in this clinical study
15. having a condition of malabsorption syndrome or multiple factors that interfere with the oral administration and absorption of medication
16. other uncontrolled conditions of clinical significance
17. other factors that, in the opinion of the Investigator, may affect the results of the study and interfere with the patient's participation in the study, including previous or existing medical conditions, abnormalities in treatment or laboratory tests, unwillingness of the subject to comply with the procedures, restrictions and requirements of the study, and other conditions that make enrollment in the study unsuitable.

Where this trial is running

Tianjin, Tianjin Municipality

• Institute of Hematology & Blood Diseases Hospital — Tianjin, Tianjin Municipality, China (Recruiting)

Study contacts

• Principal investigator: Jianxiang Wang, MD — Institute of Hematology & Blood Diseases Hospital, China
• Study coordinator: Kai Yan

Conditions Hematologic Malignancy; Non Hodgkin Lymphoma; Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia, Adult; Myelodysplastic Syndromes