A Clinical Study Exploring the Safety, Efficacy and Metabolic Kinetics of CT1182 Injection in Patients With Relapsed / Refractory Non Hodgkin Lymphoma

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology

About this trial

This study is a single arm, open label, dose exploring clinical study to evaluate the safety, efficacy, metabolic kinetics and pharmacodynamics of CT1182 cells in patients with relapsed / refractory B-cell non Hodgkin lymphoma (r/r B-NHL).

Eligibility criteria

Qualifiers

voluntarily participate in clinical research; I fully understand and know this study and sign the informed consent form; Willing to follow and be able to complete all research procedures;

age 18-75 years (inclusive);

r/r B-NHL diagnosed by histology or cytology includes large B-cell lymphoma, Burkitt lymphoma, mantle cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (hgbl) according to the WHO classification of lymphoproliferation and tumor (5th Edition, 2022); Grade 3B follicular lymphoma (fl3b); Follicular lymphoma (FL) or marginal zone lymphoma (MZL) - transformed DLBCL; Primary mediastinal large B-cell lymphoma (pmbcl); Burkitt lymphoma (BL); Mantle cell lymphoma (MCL).

have received standardized systemic treatment in the past, including anti-CD20 drugs (except CD20 negative) and anthracyclines;

Disqualifiers

pregnant or lactating women;

research participants with a history of neurological diseases, such as epilepsy, intracranial hemorrhage, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, memory impairment, spinal cord compression, mental disease or any disease involving the central nervous system, or suspected central nervous system (CNS) metastasis;

HIV, syphilis infection, active hepatitis B virus infection (HBV-DNA higher than the detection limit or positive), or active hepatitis C virus infection (HCV-RNA positive);

according to the investigator's judgment, there is currently any uncontrollable active infection, including but not limited to active tuberculosis;

Trial design

Treatments tested in this trial

  • CT1182 injection

Treatment groups

24 Participants
are divided into 1 treatment group

Sponsors and collaborators