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Diffuse Large B-cell-lymphomaPhase 1C402NCT06830031

Clinical Study of C402-CD19-CAR Treatment in Subjects With Relapsed or Refractory B-cell Lymphoma

A Phase 1 study testing C402-CD19-CAR in people with Diffuse Large B-cell-lymphoma and DLBCL, Nos Genetic Subtypes, run by Shanghai Exuma Biotechnology Ltd. 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
Search all trials

Trial summary

This study is to investigate the safety and tolerability of C402-CD19-CAR treatment in subjects with relapsed or refractory large B-cell lymphoma and further determine the recommended Phase 2 dose of C402-CD19-CAR. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
C402-CD19-CAR
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteChina
Study dates
25 Mar 2025to 18 Sep 2029
Phase
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

  • Must meet all the following inclusion criteria:
  • Male or female 18-75 years (inclusive);
  • Patients can understand this study and capable of providing informed consent;
  • Patients with willingness to be in the study and comply with the study visit procedures and other protocol requirements;
  • Diagnosed with CD19-positive large B-cell lymphoma (LBCL) based on cytology or histology according to the WHO 2016 standards, including diffuse large B-cell lymphoma not otherwise specified (DLBCL-NOS), grade 3b follicular lymphoma (FL), transformed diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma (PMBL), high-grade B-cell lymphoma (HGBL) with MYC, BCL-2, and/or BCL-6 rearrangements, and high-grade B-cell lymphoma not otherwise specified (HGBL-NOS). For CD19 expression status, subjects with a clear past record of tumor histological diagnosis as CD19-positive (within 6 months prior to screening with no CD19-related treatment in the last 6 months) and tumors showing CD19-positive lymphoma levels ≥ 50% by IHC or CD19-positive lymphoma levels ≥ 70% by flow cytometry. If there is no previous CD19 tumor testing or the result is over 6 months prior to screening, a new tumor pathology sample must be provided or re-collected for CD19-positive diagnosis by the institution, with IHC showing CD19-positive lymphoma levels ≥ 50% or flow cytometry showing CD19-positive lymphoma levels ≥ 70%.
  • For refractory or relapsed large B-cell lymphoma subjects, must have received at least anthracycline-based therapy and rituximab (or other CD20-targeted drugs, excluding CD20-negative cases). If previously treated with R-CHOP or other CD20-targeted therapy, the best treatment outcome prior to relapse must have been complete remission (CR). Subjects should meet the criteria for relapse, progression, or failure after second-line therapy; or relapse after autologous hematopoietic stem cell transplantation (auto-HSCT). If the subject has undergone previous auto-HSCT, the best treatment outcome prior to relapse must have been CR, and the relapse should occur more than 12 months after the previous treatment. (Refractory is defined as the best response to the most recent treatment being disease progression or stable disease after at least 2 cycles of the last-line therapy).
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  • According to the 2014 Lugano Treatment Response Assessment Criteria, at least one measurable tumor lesion should be present (lesions can be measured with PET results; lymph node lesions [long axis LDi > 15mm] or extra nodal lesions [long axis LDi > 10mm]);
  • Expected survival time greater than 12 weeks;
  • ECOG score of 0-1;
  • Able to establish an intravenous route for PBMC collection, meeting the following hematologic parameters before screening: Hemoglobin ≥ 80 g/L, absolute neutrophil count ≥ 1.0 × 10^9/L, platelet count ≥ 75 × 10^9/L, lymphocyte count ≥ 0.5 × 10^9/L (if using bone marrow stimulants or blood transfusion, a washout period of 7 days is required; for granulocyte colony-stimulating factor [G-CSF] or granulocyte-macrophage colony-stimulating factor [GM-CSF], a washout period of 4 weeks or 5 half-lives is required);
  • Liver and kidney function, as well as heart and lung function, should meet the following requirements:
  • Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min (using the Cockcroft-Gault formula);
  • Ejection fraction ≥ 50%, with no clinically significant pericardial effusion or pleural effusion detected;
  • Oxygen saturation ≥ 92% without oxygen support;
  • Total bilirubin ≤ 1.5 × ULN (for patients with Gilbert's syndrome or lymphoma involving the liver, ≤ 3 × ULN);
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN;
  • Fibrinogen ≥ 1.0 g/L; activated partial thromboplastin time ≤ 1.5 × ULN, prothrombin time (PT) ≤ 1.5 × ULN;
  • No more than 1 month prior to screening, the subject must have participated in another interventional clinical study and recovered to a severity level of ≤ 1 for any treatment-related adverse events.

Who cannot join

  • History of receiving allogeneic hematopoietic stem cell transplantation, adoptive cell therapy (such as CAR-T therapy), or other gene-modified cell therapies;
  • Any active central nervous system (CNS) involvement (including symptomatic and asymptomatic), or a history of CNS disease (such as epilepsy, cerebral ischemia/hemorrhage, dementia, cerebellar disorders, or any autoimmune diseases involving the CNS);
  • Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA positivity, or subjects with HBV titers above the upper limit of the normal range for the study center; positive for hepatitis C virus (HCV) antibody and peripheral blood HCV RNA positivity; positive for cytomegalovirus (CMV) DNA; positive for human immunodeficiency virus (HIV) antibody; positive for syphilis test;
  • Any unstable systemic disease, including but not limited to unstable angina, cerebrovascular accident or transient ischemic attack (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association [NYHA] classification ≥ III), active bleeding, severe arrhythmias requiring drug treatment, liver, kidney, or metabolic disorders;
  • Presence of malignant tumors other than large B-cell lymphoma, except for cured non-melanoma skin cancer, carcinoma in situ of the cervix, localized prostate cancer, superficial bladder cancer, ductal carcinoma in situ, and other cancers with a disease-free survival of more than 5 years;
  • Presence of gastric lymphoma, bulky disease, a history of CD19+ leukemia, or active autoimmune diseases (e.g., systemic lupus erythematosus, Sjögren's syndrome, rheumatoid arthritis, psoriasis, multiple sclerosis, inflammatory bowel disease, Hashimoto's thyroiditis, etc.);
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  • Presence of uncontrolled active infections requiring treatment (e.g., sepsis, bacteremia, fungemia, viremia) (mild urinary tract infections or upper respiratory tract infections are exceptions), with the exception of prophylactic anti-infection treatment (for bacterial, fungal, viral infections, etc.);
  • Subjects who have received systemic steroid treatment within 2 weeks before PBMC collection and are determined by the investigator to require long-term systemic steroid treatment during the treatment period (except for inhaled, local application, or physiological replacement doses [hydrocortisone ≤7 mg·d-1 or equivalent prednisone ≤5 mg·d-1 or dexamethasone ≤0.5 mg·d-1]);
  • Subjects who have received anti-tumor treatment within 8 weeks or 5 half-lives (specific medications need to be assessed in detail) before PBMC collection, including chemotherapy, CD20-targeted therapy, etc.; local radiotherapy within 12 weeks;
  • Subjects who have used granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) within 4 weeks before PBMC collection or within at least 5 half-lives (whichever is shorter);
  • Subjects who have received alendronate treatment within 6 months before PBMC collection, or who have received fludarabine, cladribine, or bendamustine treatment within 3 months before PBMC collection;
  • Subjects who have undergone major surgery within 4 weeks prior to screening (as defined by "Clinical Application Measures of Medical Technology" and "Grade 3 and 4 surgeries") or who have not fully recovered from any previous invasive procedure;
  • Subjects who have received a live vaccine within 28 days before PBMC collection;
  • Pregnant or breastfeeding women, or those who plan to become pregnant during the treatment period or within 2 years after treatment, or male subjects whose partners plan to become pregnant within 2 years after male subject's cell injection;
  • Subjects whom the investigator deems unsuitable to participate in this trial.

Trial locations and contacts

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

Xue Zhang, Master contact

0086-18020181261

xue.zhang2@kuntuo.com

Yansong Li, Master contact

0086-15618427667

yansong.li@kuntuo.com

China1 site, 1 recruiting

  • Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences

    Tianjin, 300020

    Jianfeng Huo, Bachelor, 0086-17320062857, jianfeng.huo@kuntuo.com

    Xue Zhang, Master, 0086-18020181261, xue.zhang2@kuntuo.com

    Recruiting

Other trials in China

About this study

Official title: A Phase 1 Study of C402-CD19-CAR, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Targeting CD19 in Subjects With Relapsed or Refractory Large B-cell Lymphoma

This study is to investigate the safety and tolerability of C402-CD19-CAR treatment in subjects with relapsed or refractory large B-cell lymphoma and further determine the recommended Phase 2 dose of C402-CD19-CAR.

Read the detailed description

This is a single-arm, open-label, phase 1 clinical study of C402-CD19-CAR cell therapy, to evaluate the safety, tolerability, efficacy of C402-CD19-CAR in subject with relapsed or refractory large B cell lymphoma.

Subjects that meet inclusion criteria with positive CD19 (IHC ≥50% tumor cells or FACS ≥70% tumor cells) will receive C402-CD19-CAR treatment according to the modified 2+3+3 dose escalation design.

Being tested
C402-CD19-CAR
Keywords
autologous fast CAR-T, CD19, B cell lymphoma, subcutaneous injection, without lymphodepletion
Medical subject headings
Dendritic Cell Sarcoma, Interdigitating, Pyloric Stenosis, Hypertrophic, Lymphoma, B-Cell

What participants receive

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

  • C402-CD19-CARBiological

    Enrolled subjects will undergo apheresis to acquire peripheral blood mononuclear cells. C402-CD19-CAR will be generated from the subject's autologous T cells modified from the apheresis product. After C402-CD19-CAR production and product release, subjects will be administered with a single dose of C402-CD19-CAR via subcutaneous injection.

Study groups in NCT06830031
Study groupRoleWhat they receive
C402-CD19-CARExperimentalTo determine the safety, tolerability, dose-limiting toxicities (DLT) and maximum tolerated dose (MTD) of C402-CD19-CAR cell therapy in patients with relapsed or refractory large B cell lymphoma. Dose cohorts: * Dose level 1: 0.3x105 CD19 CAR positive cells/kg body weight, subcutaneous injection * Dose level 2: 1 x105 CD19 CAR positive cells/kg body weight, subcutaneous injection * Dose level 3: 3 x105 CD19 CAR positive cells/kg body weight, subcutaneous injection
Receives: Biological: C402-CD19-CAR

What is being measured

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

  1. MTD (maximum tolerated dose) of C402-CD19-CAR

    To evaluate the DLT (dose limiting toxicities), attributed to C402-CD19-CAR per cohort and determine the RP2D (recommended phase 2 dose).

    Measured: 28 days following injection

  2. AE (Adverse Event), AESI (Adverse Event of Special Interest), SAE (Severe Adverse Event)

    The incidence, severity and duration of AE, AESI and SAE as determined by NCI-CTCAE v5.0

    Measured: up to 2 years post injection

Secondary outcomes (15)

  1. ORR (Objective Response Rate)

    ORR and best overall response (BOR) of subjects with PR (partial response) and CR (complete response) as determined by local investigator using Lugano 2014

    Measured: up to 2 years post injection

  2. DOR (Duration of response)

    The duration of time from record of response to first progression of disease or death as determined by Lugano 2014

    Measured: up to 2 years post injection

  3. PFS (Progression free survival)

    The duration of time from treatment to first progression of disease as determined by Lugano 2014

    Measured: up to 2 years post injection

  4. DCR (Disease control rate)

    The proportion of subjects with CR (complete response), PR (partial response) or SD (stable disease lasting over 6 months) to total number of patients treated as determined by local investigator using Lugano 2014

    Measured: up to 2 years post injection

  5. OS (Overall Survival)

    The time from the start of treatment to the occurrence of death due to any cause

    Measured: up to 15 years post injection

  6. PK (Pharmacokinetics): AUCinf

    Calculate AUCinf: area under the blood concentration-time curve extrapolated to infinity

    Measured: up to 2 years post injection

  7. PK: AUC(0-t)

    calculate AUC(0-t): the AUC from time 0 to the last measurable concentration that represents the observed exposure to a drug

    Measured: up to 2 years post injection

  8. PK: AUC0-28d

    calculate AUC0-28d: the area under the concentration-time curve from day 0 to day 28

    Measured: up to 2 years post injection

  9. PK: AUC0-90d

    Calculate AUC0-90d: the area under the concentration-time curve from day 0 to day 90

    Measured: up to 2 years post injection

  10. PK: Cmax

    Calculate Cmax: the highest concentration of the drug in the blood

    Measured: up to 2 years post injection

  11. PK: half-life

    Calculate half-life: the time it takes for the amount of the drug's active substance in your body to reduce by half

    Measured: up to 2 years post injection

  12. PK: Tmax

    Calculate Tmax: the time it takes for the drug to reach the maximum concentration after administration of a drug that needs to be absorbed

    Measured: up to 2 years post injection

  13. PK: MRT

    Calculate MRT (Mean Residence Time): the average time a molecule spends in a system before being removed)

    Measured: up to 2 years post injection

  14. Concentration of cytokines

    Test serum concentration of IL-2、IL-4、IL-6、IL-10、IFN-γ、TNF-α before and post C402-CD19-CAR treatment

    Measured: up to 2 years post injection

  15. Concentration of Anti-Drug Antibody

    Test antibodies that form in response to the administration of C402-CD19-CAR

    Measured: up to 2 years post injection

Timeline

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

  1. First posted17 Feb 2025
  2. Study start25 Mar 2025
  3. Primary completion28 Apr 2029 (estimated)
  4. Study completion18 Sep 2029 (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
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06830031
Sponsor's protocol ID
C402-001
Acronym
C402
Status last verified
Sep 2026
First submitted
6 Feb 2025
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Liu W, Liu J, Song Y, Zeng X, Wang X, Mi L, Cai C, Wang L, Ma J, Zhu J; Union for China Leukemia Investigators of the Chinese Society of Clinical Oncology; Union for China Lymphoma Investigators of the Chinese Society of Clinical Oncology. Burden of lymphoma in China, 2006-2016: an analysis of the Global Burden of Disease Study 2016. J Hematol Oncol. 2019 Nov 19;12(1):115. doi: 10.1186/s13045-019-0785-7.

    PubMed 31744509

  • Liu W, Liu J, Song Y, Wang X, Mi L, Cai C, Zhao D, Wang L, Ma J, Zhu J. Burden of lymphoma in China, 1990-2019: an analysis of the global burden of diseases, injuries, and risk factors study 2019. Aging (Albany NY). 2022 Apr 10;14(7):3175-3190. doi: 10.18632/aging.204006. Epub 2022 Apr 10.

    PubMed 35398840

  • Zahid U, Akbar F, Amaraneni A, Husnain M, Chan O, Riaz IB, McBride A, Iftikhar A, Anwer F. A Review of Autologous Stem Cell Transplantation in Lymphoma. Curr Hematol Malig Rep. 2017 Jun;12(3):217-226. doi: 10.1007/s11899-017-0382-1.

    PubMed 28478586

  • Li X, Ding Y, Zi M, Sun L, Zhang W, Chen S, Xu Y. CD19, from bench to bedside. Immunol Lett. 2017 Mar;183:86-95. doi: 10.1016/j.imlet.2017.01.010. Epub 2017 Jan 30.

    PubMed 28153605

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing C402-CD19-CAR in people with Diffuse Large B-cell-lymphoma and DLBCL, Nos Genetic Subtypes, run by Shanghai Exuma Biotechnology Ltd. 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 15 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 11 Sep 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?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 Xue Zhang, Master (0086-18020181261, xue.zhang2@kuntuo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MTD (maximum tolerated dose) of C402-CD19-CAR (time frame: 28 days following injection). 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 NCT06830031, which also lists 4 linked publications.

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 11 Sep 2026.

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