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

NCT07548697 | Recruiting Early Phase 1

• 1 other identifier: CT1182-CG11014
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

B-cell Non Hodgkin Lymphoma (NHL); DLBCL - Diffuse Large B Cell Lymphoma; Follicular Lymphoma (FL)

Keywords

CT1182; CT1182-CG11014; NHL; DLBCL; FL

Outcome Measures

Primary Outcomes (2)

• Frequency, type and severity of AES

  To evaluate the severity and incidence of treatment-related adverse events (TARE) and adverse events of special concern (AESI) after CT1182 infusion

  Within 24 months after CT1182 infusion

• The number and severity of dose-limiting toxicity (DLT)events

  DLT was collected to explore the maximum tolerated dose (MTD) and / or dose range of CT1182

  Within 28 days after CT1182 infusion

Secondary Outcomes (10)

• Investigator assessed objective response rate (ORR)

  The evaluation was performed within 24 months after CT1182 infusion, such as 4 weeks, 8 weeks, 12 weeks, 6 months, 9 months, 12 months, 18 months, 24 months, after CT1182 infusion

• Investigator assessed complete response rate (CRR)

  The evaluation was performed within 24 months after CT1182 infusion, such as 4 weeks, 8 weeks, 12 weeks, 6 months, 9 months, 12 months, 18 months, 24 months, after CT1182 infusion

• Investigator assessed duration of remission (DOR)

  The evaluation was performed within 24 months after CT1182 infusion, such as 4 weeks, 8 weeks, 12 weeks, 6 months, 9 months, 12 months, 18 months, 24 months, after CT1182 infusion

• Investigator assessed time to remission (TTR)

  The evaluation was performed within 24 months after CT1182 infusion, such as 4 weeks, 8 weeks, 12 weeks, 6 months, 9 months, 12 months, 18 months, 24 months, after CT1182 infusion

• Investigator assessed time to complete remission (TTCR)

  The evaluation was performed within 24 months after CT1182 infusion, such as 4 weeks, 8 weeks, 12 weeks, 6 months, 9 months, 12 months, 18 months, 24 months, after CT1182 infusion

Study Arms (1)

CT1182 injection

EXPERIMENTAL

Biological: CT1182 injection

Interventions

CT1182 injection BIOLOGICAL

CT1182 injection is an in vivo car-t product (CT1182) independently developed by carsgen company based on carvivo ™ platform, which simultaneously targets CD19 and CD20. Carvivo ™ platform uses redirected lentiviral vector technology to directly target and transduce T cells and generate functional car-t cells in vivo after intravenous infusion of lentivirus to achieve specific targeted killing of tumor cells. The CT1182 product adopts an optimized mutant engineered vesicular stomatitis virus (VSV) envelope, which makes the lentivirus lose its pan tropism. At the same time, it loads redirected CD3 targeting molecules on the virus surface to achieve specific transduction of T cells.

CT1182 injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%;

You may not qualify if:

• 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;
• there is known or suspected long-term active infection of EBV and a known history of HLH;
• have received autologous stem cell transplantation or autologous cell therapy within 3 months before signing the informed consent; Previously received allogeneic stem cell transplantation or allogeneic donor derived cell adoptive therapy;
• have received previous treatment targeting CD19 (unless the CD19 or CD20 target test is still positive);
• previously received pseudotyped viral vector related treatment with vesicular stomatitis virus glycoprotein (VSVG) as envelope protein (including but not limited to VSVG pseudotyped lentivirus, adenovirus or other viral vector mediated gene therapy, oncolytic virus therapy, etc.);
• CT1182 has received anti-tumor treatment within 14 days before infusion or within 5 half lives (whichever is shorter), including but not limited to cytotoxic drugs, targeted therapy, radiotherapy, epigenetic therapy or experimental drug treatment, or has used invasive experimental medical devices. ;
• receive systemic glucocorticoids equivalent to \>15 mg/ day prednisone within 7 days before signing the informed consent, except for topical glucocorticoids or physiological replacement therapy;
• have been vaccinated within 4 weeks before signing the informed consent, or it is expected that live attenuated vaccine, inactivated vaccine or RNA vaccine will be vaccinated during the trial or within 12 months after ct1182 infusion;
• known allergy to ct1182 or any formulation component, allergy or intolerance to tocilizumab, or previous history of other serious allergies such as anaphylactic shock;
• study participants with any of the following cardiac diseases:
• The New York Heart Association (NYHA) cardiac function classification was grade III or IV heart failure;
• Myocardial infarction, unstable angina pectoris, or coronary artery bypass grafting or coronary stent implantation occurred within 6 months before screening;

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead
• CARsgen Life Sciences Co.,Ltd.: collaborator

Study Sites (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell; Dendritic Cell Sarcoma, Interdigitating; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Histiocytic Disorders, Malignant; Histiocytosis

Central Study Contacts

Heng Mei, M.D., Ph.D

CONTACT

07596503286; hmei@hust.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: April 23, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)