CT1182 CAR‑T infusion for adults with relapsed or refractory B‑cell non‑Hodgkin lymphoma

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

This trial tests whether a CT1182 CAR‑T cell infusion is safe and can help adults 18–75 with relapsed or refractory B‑cell non‑Hodgkin lymphoma.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology (Academic / other)
• Drugs / interventions: tocilizumab, prednisone, car-t
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT07548697 on ClinicalTrials.gov

What this trial studies

This single‑arm, open‑label Phase 1 dose‑escalation study will give escalating doses of CT1182 CAR‑T cells to adults with relapsed or refractory B‑cell NHL to characterize safety, tolerability, metabolic kinetics, and pharmacodynamics. Tentative dose levels include 1.2×10^8, 3.0×10^8, 6.0×10^8, and 1.2×10^9 transduced units using a BOIN escalation design with a target MTD toxicity probability of 30%. The study plans to enroll about 3–24 participants with a 28‑day DLT observation window after the first infusion and monitoring of CAR‑T expansion (CD19/CD20) and other biomarkers. Investigators and sponsor may adjust dose escalation based on observed toxicities or lack of biological activity at lower doses.

Who should consider this trial

Good fit: Adults 18–75 with relapsed or refractory B‑cell NHL (including DLBCL, FL, MZL, MCL, PMBCL, or BL) who have received prior anti‑CD20 and anthracycline‑containing therapy, can consent, and can comply with study procedures.

Not a fit: Patients with CD20‑negative disease, major medical comorbidities, or who cannot tolerate CAR‑T therapy or required hospitalization and follow‑up are unlikely to benefit.

Why it matters

Potential benefit: If successful, CT1182 could become a new CAR‑T option that induces remissions in some patients with relapsed or refractory B‑cell NHL.

How similar studies have performed: Other CAR‑T therapies targeting B‑cell antigens have produced remissions in relapsed/refractory B‑cell NHL, so the general approach has shown clinical activity though CT1182 itself is investigational.

Eligibility criteria

Inclusion Criteria:

* 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:

  1. 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;
  2. 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):

  1. ;
  2. Endogenous creatinine clearance ≥ 50 ml/min (using Cockcroft Gault formula), or creatinine ≤ 1.5 × ULN;
  3. 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;
  4. The international normalized ratio (INR) and activated partial thromboplastin time (APTT) should be ≤ 1.5 × ULN.
  5. Blood oxygen saturation in non oxygen inhalation state ≥ 92%;
  6. 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.

Exclusion Criteria:

* 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:

  1. The New York Heart Association (NYHA) cardiac function classification was grade III or IV heart failure;
  2. Myocardial infarction, unstable angina pectoris, or coronary artery bypass grafting or coronary stent implantation occurred within 6 months before screening;
  3. There is a history of clinically significant uncontrolled arrhythmias, such as ventricular arrhythmias;
  4. ;
  5. Other heart diseases that the investigator believes may endanger the safety of study participants due to participation in this study;
* suffering from serious lung disease, and participating in this study may endanger the safety of participants according to the judgment of the investigator;
* the second primary malignant tumor requiring treatment or incomplete remission in the past 3 years, except the following successfully treated tumors with low malignancy such as non metastatic basal cell carcinoma or squamous cell skin carcinoma, non metastatic prostate cancer, breast cancer or cervical cancer in situ, non muscle invasive bladder cancer or thyroid cancer;
* there is active systemic autoimmune disease, which requires long-term treatment with immunosuppressants;
* major surgery within 2 weeks before signing the informed consent, or major surgery planned during the study or within 4 weeks after giving the study treatment (excluding cataract and other local anesthesia surgery);
* the investigator assessed that the participants were unable or unwilling to comply with the requirements of the study protocol, or were not suitable to participate in this clinical study for other reasons.

Where this trial is running

Wuhan, Hubei

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)

Study contacts

• Study coordinator: Heng Mei, M.D., Ph.D

Conditions B-cell Non Hodgkin Lymphoma; DLBCL - Diffuse Large B Cell Lymphoma; Follicular Lymphoma; CT1182; CT1182-CG11014; NHL; DLBCL; FL