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B-cell Non Hodgkin Lymphoma (NHL)Early Phase 1NCT07548697

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

A Early Phase 1 study testing CT1182 injection in people with B-cell Non Hodgkin Lymphoma (NHL) and DLBCL - Diffuse Large B Cell Lymphoma, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
CT1182 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteChina
Study dates
30 Apr 2026to 31 Dec 2028
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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.

Who cannot join

  • 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;
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  • 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;
  • There is a history of clinically significant uncontrolled arrhythmias, such as ventricular arrhythmias;
  • ;
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Heng Mei, M.D., Ph.D contact

07596503286

hmei@hust.edu.cn

China1 site, 1 recruiting

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

    Wuhan, Hubei, 430000

    Heng Mei, M.D., Ph.D, 07596503286, hmei@hust.edu.cn

    Recruiting

Other trials in China

About this study

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).

Read the detailed description

The MTD target toxicity probability of this study is set at 30%. Four dose levels are tentatively determined for dose increment: 1.2 × 10 ^ 8, 3.0 × 10 ^ 8, 6.0 × 10 ^ 8, 1.2 × 10 ^ 8 Tu CT1182. It is planned to enroll 3-24 participants. The number of cases in each dose group shall be subject to the actual situation. The dose increment method of Boin design was used for dose increment. If the exploration dose is not confirmed as the possible maximum tolerated dose (MTD), the investigator and the sponsor can jointly discuss whether to increase to a higher dose or decrease to a lower dose to explore the possible MTD. The observation period of DLT was 28 days after the first infusion. If no obvious expansion of CD19/CD20 car-t cells is detected within 28 days after infusion, the researchers judged that the treatment may be ineffective due to the low infusion dose, or the study participants may withdraw from the treatment early due to disease progression and other reasons, and it is still necessary to continue to observe the safety of the study participants until the 28 day observation period is completed. If DLT is not observed, and the investigator evaluates that the dose of this dose group is too low to benefit the patients, the dose group can no longer continue to be included in the study participants, but can continue to climb the dose of the next dose group. The main purpose of this study was to explore the safety and tolerability of CT1182 among the study participants. The primary endpoint was to evaluate the frequency, type and severity of adverse events after CT1182 infusion, as well as DLT and MTD.

Being tested
CT1182 injection
Keywords
CT1182, CT1182-CG11014, NHL, DLBCL, FL
Medical subject headings
Lymphoma, B-Cell, Dendritic Cell Sarcoma, Interdigitating, Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CT1182 injectionBiological

    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.

Study groups in NCT07548697
Study groupRoleWhat they receive
CT1182 injectionExperimentalNot described
Receives: Biological: CT1182 injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Within 24 months after CT1182 infusion

  2. 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

    Measured: Within 28 days after CT1182 infusion

Secondary outcomes (10)

  1. Investigator assessed objective response rate (ORR)

    Measured: 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

  2. Investigator assessed complete response rate (CRR)

    Measured: 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

  3. Investigator assessed duration of remission (DOR)

    Measured: 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

  4. Investigator assessed time to remission (TTR)

    Measured: 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

  5. Investigator assessed time to complete remission (TTCR)

    Measured: 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

  6. Investigator assessed progression free survival (PFS)

    Measured: 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

  7. Overall survival (OS)

    Measured: 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

  8. Levels of free lentiviral vectors in peripheral blood

    Measured: Before administration, 6 hours after administration and 24, 48 and 96 hours after administration

  9. The level of CD19/CD20 CAR gene copy number

    Measured: Day 0 before CT1182 infusion, Day 1, Day 2, Day 4, Day 6,Day 8, Day 10, Day 12, Day 14, Day 17, Day 21, Day 28, Week 8,Week 12, Month 6, Month 9 and Month 12 after CT1182 infusion

  10. Duration of CD19/CD20 CAR gene copy number

    Measured: Day 0 before CT1182 infusion, Day 1, Day 2, Day 4, Day 6,Day 8, Day 10, Day 12, Day 14, Day 17, Day 21, Day 28, Week 8,Week 12, Month 6, Month 9 and Month 12 after CT1182 infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2026
  2. Study start30 Apr 2026 (estimated)
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07548697
Sponsor's protocol ID
CT1182-CG11014
Status last verified
Apr 2026
First submitted
16 Apr 2026
Last updated
23 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing CT1182 injection in people with B-cell Non Hodgkin Lymphoma (NHL) and DLBCL - Diffuse Large B Cell Lymphoma, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Heng Mei, M.D., Ph.D (07596503286, hmei@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency, type and severity of AES (time frame: Within 24 months after CT1182 infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07548697.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.

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