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NCT07823829
A Phase I/II Trial of CT1190B in Patients With Relapsed/Refractory Large B-Cell Lymphoma
Conditions: Large B-Cell Lymphoma (LBCL)
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 68
Sponsor: UCARsgen Biotech Limited
Location: Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine Shanghai Shanghai Municipality
Summary
This is a single-arm, open-label, dose-finding Phase I/II clinical trial to evaluate the safety, efficacy, cellular pharmacokinetics, and pharmacodynamics of CT1190B cells in patients with R/R LBCL.
Eligibility Criteria
Inclusion Criteria:
* Volunteer to participate in the clinical trial; participants fully understand and are informed of this trial and sign the informed consent form; Willing to follow and able to complete all trial procedures;
* Age 18 \~ 75 years (inclusive);
* Histologically or cytologically confirmed large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma unspecified (DLBCL, NOS), primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma(HGBL), large B-cell lymphoma (FLBL) transformed by follicular lymphoma (FL)/Grade 3b FL;
* Has received at least 2 prior lines of standard systemic therapy and has relapsed after adequate treatment or meets refractory criteria.
* If the participant has received prior CD19-targeted therapy, the tumor tissue should be re-collected at least 4 weeks after the last dose for CD19 and CD20 detection to confirm that the expression of CD19 or CD20 is positive;
* Presence of at least one measurable lesion according to the Lugano 2014 criteria (a previously irradiated lesion is not to be considered measurable or non-measurable unless it has unequivocal progression or tumor activity after completion of radiation therapy), at least one of the following conditions is required:As measured by computed tomography (CT) or magnetic resonance imaging (MRI): nodal lesions \> 1.5 cm in long diameter or extranodal lesions \> 1.0 cm in long diameter;
* Estimated survival \> 12 weeks;
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
* Participants should meet the following test results (there should be no ongoing supportive care):
* Female participants of child-bearing potential must have a negative pregnancy test at screening and before receiving clearing therapy, be willing to use a highly effective and reliable method of contraception within 1 year after receiving trial therapy, and absolutely prohibit egg donation within 1 year after receiving trial therapy infusion during the trial; A male participant, if sexually active with a female of childbearing potential, is willing to use a highly effective and reliable method of contraception for 1 year after receiving trial treatment. All male participants absolutely refrain from donating sperm for 1 year after receiving the trial treatment infusion during the trial.
Exclusion Criteria:
* Pregnant or lactating women;
* Presence of HIV, syphilis infection, active hepatitis B virus infection, active hepatitis C virus infection, DNA positive (whole blood or plasma), cytomegalovirus (CMV) DNA positive;
* Any uncontrollable active infection;
* The toxic side effects caused by the participant's previous treatment have not recovered to the standard for adverse events (CTCAE v6.0) ≤ 1, except for hair loss and other tolerable events determined by the researcher;
* Individuals with known symptomatic central nervous system (CNS) disorders or suspected involvement of CNS lymphoma;
* Patients with lymphoma involving the small intestine or the muscular layers of the stomach and colon;
* Received autologous hematopoietic stem cell transplantation within 12 weeks prior to signing the informed consent form;
* Participants have received allogeneic hematopoietic stem cell transplantation in the past;
* Participants who have previously received targeted CD19 CAR-T therapy and have tested positive for anti drug antibodies (ADA) within the last 4 weeks prior to signing the main informed consent form;
* Vaccination with live or attenuated vaccines within 4 weeks prior to signing the informed consent form;
* Select patients with any of the following heart diseases within the first 6 months of screening:
* Blood oxygen saturation\
Source: ClinicalTrials.gov (NCT07823829). StuddyBuddy aggregates publicly available trial information.