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

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• 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;

• intolerance during the last treatment, or the investigator assessed the need for new treatment after the last treatment;

• meet at least one of the following conditions:

‣ According to CT measurement: the long diameter of intranodal lesions is \>1.5 cm, or the long diameter of extranodal lesions is \>1.0 cm, and the short diameter can be measured;

⁃ According to PET measurement: FDG uptake score reaches 4 or 5;

• estimated survival \>12 weeks;

• Eastern Cooperative Oncology Group (ECoG) score 0-1;

• participants should meet the following test results (they have not received any granulocyte colony-stimulating factor (G-CSF) / granulocyte macrophage colony-stimulating factor (GM-CSF) treatment and supportive treatment of red blood cell and platelet transfusion within 7 days before laboratory examination):

‣ ;

⁃ Endogenous creatinine clearance ≥ 50 ml/min (using Cockcroft Gault formula), or creatinine ≤ 1.5 × ULN;

⁃ Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN, total bilirubin ≤ 1.5 × ULN; If lymphoma invades the liver: AST and alt ≤ 5 × ULN, total bilirubin ≤ 3.0 × ULN;

⁃ The international normalized ratio (INR) and activated partial thromboplastin time (APTT) should be ≤ 1.5 × ULN.

⁃ Blood oxygen saturation in non oxygen inhalation state ≥ 92%;

⁃ Left ventricular ejection fraction (LVEF) ≥ 50% (LVEF value is near the critical value, and can be enrolled after the investigator has fully assessed the risk);

• female participants with childbearing potential must have a pregnancy test at the time of screening and the result is negative. They are willing to use very effective and reliable methods of contraception within 1 year after receiving study treatment. It is absolutely prohibited to donate eggs within 1 year after receiving study treatment infusion during the study period; Male participants who had active sex with women with reproductive potential were willing to use very effective and reliable methods of contraception within 1 year after receiving study treatment. All male participants were absolutely forbidden to donate sperm within 1 year after receiving study treatment infusion during the study period.

Locations
Other Locations
China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
Contact Information
Primary
Heng Mei, M.D., Ph.D
hmei@hust.edu.cn
07596503286
Time Frame
Start Date: 2026-04-30
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 24
Treatments
Experimental: CT1182 injection
Sponsors
Leads: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborators: CARsgen Life Sciences Co.,Ltd.

This content was sourced from clinicaltrials.gov

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