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Evaluating TQB3909 tablets for patients with recurrent or refractory CLL/SLL

A Phase Ib/II Clinical Trial on the Safety and Efficacy of TQB3909 Tablets in Patients With Recurrent or Refractory CLL/SLL.

Phase1; Phase2 Interventional Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · NCT05959694

This study is testing if TQB3909 tablets can safely help people with recurrent or hard-to-treat Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL).

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment107 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd. Industry-sponsored
Drugs / interventionsCAR-T, Chimeric Antigen Receptor, chemotherapy, Immunotherapy
Locations25 sites (Anqing, Anhui and 24 other locations)
Trial IDNCT05959694 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and efficacy of TQB3909 tablets in patients diagnosed with recurrent or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). It is designed as a Phase Ib/II trial, meaning it will evaluate both the initial safety and the effectiveness of the treatment in a larger group of patients. Participants must meet specific eligibility criteria, including age and performance status, and will be monitored for measurable lesions through imaging techniques. The study seeks to provide insights into a new therapeutic option for these challenging hematological malignancies.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with recurrent or refractory CLL/SLL who meet specific health criteria.

Not a fit: Patients with complicated diseases or medical histories that exclude them from the trial may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could offer a new effective option for patients with difficult-to-treat CLL/SLL.

How similar studies have performed: While there have been various studies on treatments for CLL/SLL, the specific approach with TQB3909 is novel and has not been extensively tested in prior trials.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Anqing, Anhui and 24 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.