TQB3909 Tablets in Subjects With Relapsed or Refractory Mantle Cell Lymphoma (MCL) (NCT06106841) | Clinical Trial Compass
TerminatedPhase 1/2
TQB3909 Tablets in Subjects With Relapsed or Refractory Mantle Cell Lymphoma (MCL)
Stopped: Study terminated for strategic business reasons
China19 participantsStarted 2023-10-05
Plain-language summary
This is a study to assess the safety of TQB3909 monotherapy in participants with relapsed or refractory MCL.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* The subject voluntarily joins the study, signs the informed consent form, and has good compliance;
* Age: ≥ 18 years old (when signing the informed consent form); Eastern Cooperative Oncology Group performance status (ECOG PS) score: 0-2 points; Expected survival is more than 3 months;
* Subject population: Confirmed as MCL by local laboratory pathology and independent pathology review (stage 2).
* The main organs are functioning well,
* The patient's Computed Tomography (CT) / Magnetic Resonance Imaging (MRI) shows measurable lesions, defined as ≥ 1 lymph node with the longest diameter of \> 1.5 cm or ≥ 1 extranodal lesion with the longest diameter of \> 1.0 cm, which can be measured by ≥ 2 vertical dimensions;
* Female subjects of childbearing age should agree to use contraception (e.g., pills, or condoms) during the study and for 6 months after the end of the study; Have a negative serum pregnancy test within 7 days prior to study enrollment and must be a non-lactating subject; Male participants should agree that contraception must be used during the study period and for 6 months after the end of the study period.
Exclusion Criteria:
* Have had or currently have other malignant tumors within 3 years before the first dose of study drug.
* It is known that lymphoma affects the central nervous system (CNS);
* Previous allogeneic hematopoietic stem cell transplantation;
* Have received autologous hematopoietic stem cell transplantation within 3 months …
What they're measuring
1
Recommended phase II dose (RP2D)
Timeframe: Baseline up to 48-weeks
Trial details
NCT IDNCT06106841
SponsorChia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.