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.
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.
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;
Single group
CT1190B intravenous infusion
Drug68 subjects received 1190B injection for infusion
treatment-emergent adverse events (TEAE),
treatment-related adverse events (TRAE)
•serious adverse events (SAE), and adverse events of special interest (AESI)
Dose limiting toxicity (DLT)
ORR
Objective response rate (ORR) at 12 weeks
CRR
DOR
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