A Clinical Trial on the Safety and Efficacy of TQB3909 Tablets in Patients With Recurrent or Refractory Chronic Lymphocytic Leukemia (CLL) /Small Lymphocytic Lymphoma (SLL) .

CTTQ

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Small Lymphocytic Lymphoma; Chronic Lymphocytic Leukemia

Treatments: Drug: TQB3909 tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT05959694

TQB3909-Ib/II-02

Details and patient eligibility

About

This is a phase Ib/II clinical trial to evaluate the safety and efficacy of TQB3909 tablets in patients with recurrent or refractory CLL/SLL.

Enrollment: 107 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The subjects volunteered to join the study and signed informed consent form (ICF) with good compliance;
• Age: ≥ 18 years old, ≤75 years old (when signing ICF); Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: 0-1; The expected survival period is more than 3 months;
• Subjects: patients diagnosed as CLL/SLL according to the revised diagnostic criteria of 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines;
• Computed Tomography / Magnetic Resonance Imaging (CT/MRI) of patients with SLL showed measurable lesions;
• Female subjects of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; serum pregnancy/urine pregnancy test within 7 days before study enrollment;

Exclusion criteria

• Complicated diseases and medical history:

  1. It has appeared or is currently suffering from other malignant tumors within 3 years before the first medication. The following two situations can be included in the group: other malignant tumors treated by single surgery have achieved disease-free survival (DFS) for five consecutive years; Cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumor [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)];
  2. Lymphoma/leukemia is known to involve the central nervous system (CNS);
  3. Previously received allogeneic hematopoietic stem cell transplantation;
  4. Received autologous hematopoietic stem cell transplantation within 3 months before the first medication;
  5. Unresolved toxic reaction ≥ CTCAE grade 1 caused by any previous treatment;
  6. Arterial/venous thrombotic events occurred within 6 months before the first medication, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage and cerebral infarction), deep venous thrombosis and pulmonary embolism;
  7. Subjects with any serious and/or uncontrollable diseases;

• Tumor-related symptoms and treatment:

  1. He has received chemotherapy and radiotherapy within 4 weeks before the first medication, immune checkpoint inhibitor and Chimeric Antigen Receptor T (CAR-T)-Cell Immunotherapy within 12 weeks before the first medication, and other small molecule anti-tumor treatments (the elution period is calculated from the end of the last treatment) before the first medication are within 5 half-lives;
  2. previously received BCL-2 inhibitors;

• Research-related treatment: received the vaccine within 4 weeks before the first medication, or planned to be vaccinated during the study;

• Participated in clinical trials of other antineoplastic drugs within 4 weeks before the first medication;

• According to the investigators' judgment, there are patients with accompanying diseases that seriously endanger the safety of the subjects or affect the completion of the study, or subjects who think that there are other reasons that are not suitable for inclusion.

• Allergic to allopurinol and benzbromarone.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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107 participants in 1 patient group

TQB3909 tablets

Experimental group

Description:

Oral administration, 400mg or 600 mg, once a day, and 28 days is a treatment cycle. Continue medication until the disease progresses or intolerant toxicity appears.

Treatment:

Drug: TQB3909 tablet