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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

A Clinical Study Exploring CT1190B in the Treatment of Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma ( CT1190B-CG11001 )

A Clinical Study to Investigate the Safety, Efficacy, and Cellular Metabolism of CT1190B CAR-T Cell Therapy, in Patients With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma

A Clinical Study Exploring CT1190B in the Treatment of Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma ( CT1190B-CG11001 ) (NCT07053670) is a Phase 1 interventional studying B-Cell Non-Hodgkin Lymphoma, sponsored by Tongji Hospital. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

A Clinical Study to Investigate the Safety, Efficacy, and Cellular Metabolism of CT1190B CAR-T Cell therapy, in Patients with Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For B-Cell Non-Hodgkin Lymphoma, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 27 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Participants must voluntarily sign the willing to sign a consent form form (ICF) and must be willing and be able to adhere to the study visit schedule and other protocol requirements and agree to be in long term follow-up (LTFU) for up to 15 years as mandated by the regulatory guidelines. 2. 18-75 years old; 3. diagnosed by tissue sample (biopsy-confirmed) B-NHL, according the 5th edition of the WHO classification of haematolymphoid tumours, including: 1\) Cohort A1: Large B-cell lymphoma, including diffuse large B-cell lymphoma not other specified (DLBCL, NOS), primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma, transformed follicular large B-cell lymphoma (FLBL)/Grade 3b follicular lymphoma ( FL) ; 2) Cohort A2: Mantle cell lymphoma (MCL); 3) Cohort B1: Grade 1 \~ 3a FL; 4) Cohort B2: chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) according to iwCLL2018 diagnose criteria , with the exception of participants who are currently transformed into Richter 's syndrome; 5) Cohort C:Primary central nervous system lymphoma (PCNSL). 4. Previous treatment requirement: 1. Cohort A1: Previously received at least 2 lines of systemic therapy, including anti-CD20 drugs (unless the investigator had determined that the tumor is/is CD20 negative) and anthracycline containing regimens, anti-CD20 drugs maintenance alone will not be counted as 1 line of treatment; for participants with transformed FL (FLBL), any treatment administered prior to transformation will not be counted as a prior line. 2. Cohort A2: at least 2 prior lines of systemic therapy, including anthracycline or bendamustine-containing chemotherapy, anti-CD20 drugs ( unless the investigator had determined that the tumor is/is CD20 negative) and a BTK inhibitor; and CD20 monoclonal antibody alone will not be count as 1 line of treatment; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Participants must voluntarily sign the informed consent form (ICF) and must be willing and be able to adhere to the study visit schedule and other protocol requirements and agree to be in long term follow-up (LTFU) for up to 15 years as mandated by the regulatory guidelines. 2. 18-75 years old; 3. Histologically or cytologically confirmed B-NHL, according the 5th edition of the WHO classification of haematolymphoid tumours, including: 1\) Cohort A1: Large B-cell lymphoma, including diffuse large B-cell lymphoma not other specified (DLBCL, NOS), primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma, transformed follicular large B-cell lymphoma (FLBL)/Grade 3b follicular lymphoma ( FL) ; 2) Cohort A2: Mantle cell lymphoma (MCL); 3) Cohort B1: Grade 1 \~ 3a FL; 4) Cohort B2: chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) according to iwCLL2018 diagnose criteria , with the exception of participants who are currently transformed into Richter 's syndrome; 5) Cohort C:Primary central nervous system lymphoma (PCNSL). 4. Previous treatment requirement: 1. Cohort A1: Previously received at least 2 lines of systemic therapy, including anti-CD20 drugs (unless the investigator had determined that the tumor is/is CD20 negative) and anthracycline containing regimens, anti-CD20 drugs maintenance alone will not be counted as 1 line of treatment; for participants with transformed FL (FLBL), any treatment administered prior to transformation will not be counted as a prior line. 2. Cohort A2: at least 2 prior lines of systemic therapy, including anthracycline or bendamustine-containing chemotherapy, anti-CD20 drugs ( unless the investigator had determined that the tumor is/is CD20 negative) and a BTK inhibitor; and CD20 monoclonal antibody alone will not be count as 1 line of treatment; 3. Cohort B1: previously received at least 2 lines of systemic therapy, including anti-CD20 drugs ( unless the investigator had determined that the tumor is/is CD20 negative) and anthracycline-containing chemotherapy regimens, and CD20 monoclonal antibody alone will not be counted as 1 line of treatment; 4. Cohort B2: at least 2 prior lines of therapy, including immunotherapy or chemotherapy and a BTK inhibitor, or BTK inhibitor who are not suitable for immunotherapy or chemotherapy. 5. Cohort C:at least 1 line of therapy, including MTX based chemotherapy. 5. Intolerance to last treatment, or have progressed on or after the last treatment and currently require therapy. 6\. At least one of the following: 1\) CT or MRI testing: Intranodal lesions \> 1.5 cm in long diameter, or Extranodal lesions \> 1.0 cm in long diameter; 2)PET-CT testing: \[18F\] fluorodeoxyglucose (FDG) positron emission tomography (PET) positive lesion per Lugano criteria at screening (Deauville score 4 or 5); 3) CLL participants requiring treatment according to iwCLL criteria (refer to Appendix 4); 7. Expected survival \> 12 weeks; 8. Eastern Cooperative Oncology Group (ECOG) score 0-1,PCNSL ECOG score: 0\~3; 9. Participants should meet the following test results 1. CBC: # platelet (PLT) ≥ 75 × 10 9/L (for participants with bone marrow or peripheral blood involvement: PLT ≥ 50 × 10 9/L), #hemoglobin (Hb) ≥ 80 g/L (for participants with bone marrow or peripheral blood involvement: Hb ≥ 60 g/L); 2. Endogenous creatinine clearance ≥ 30 mL/min (using the Cockcroft -Gault formula); 3. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN and total bilirubin ≤ 1.5 × ULN ; if there is liver involvement: AST and ALT ≤ 5 × ULN and total bilirubin ≤ 3.0 × ULN ; 4. International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN. 10\. Female participants of childbearing potential must have a negative pregnancy test at screening and prior to receiving preconditioning therapy and are willing to use a highly effective and reliable method of contraception for 1 year after receiving study treatment and are absolutely prohibited from donating eggs for 1 year after receiving study treatment infusion during the study; male participants are willing to use a highly effective and reliable method of contraception for 1 year after receiving study treatment if they are sexually active with a female of childbearing potential. Sperm donation is absolutely prohibited for 1 year after receiving study treatment infusions during the study for all male participants. Exclusion Criteria: 1. Pregnant or lactating women; 2. Has HIV, syphilis infection, active hepatitis B virus infection (HBV-DNA above the detection limit), or active hepatitis C virus infection (HCV antibody and HCV-DNA positive); 3. Has any current uncontrolled active infection, including but not limited to participants with active tuberculosis (investigator 's judgment); 4. Participants' toxicities caused by previous treatment did not recover to Common Terminology Criteria for Adverse Events (CTCAE) ≤ Grade 1, except alopecia and other events that are judged tolerable by the investigator; 5. Autologous stem cell transplantation within 12 weeks prior to signing informed consent; 6. Prior therapy targeting CD19 (unless CD19 or CD20 target remains positive) ; 7. Has received treatment for the disease within 14 days or 5 half-lives (Based on a shorter period of time ) before FC, including but not limited to cytotoxic therapy, monoclonal antibodies or ADCs, targeted therapy, radiotherapy, epigenetic therapy, or investigational agents, or invasive investigational medical devices within 14 days before informed consent. If the radiation field covers ≤ 5% of the bone marrow reserve, the participant is eligible regardless of the end date of radiotherapy; 8. Systemic glucocorticoids equivalent to \> 15 mg/day prednisone within 7 days prior to informed consent, with the exception of topical glucocorticoids; 9. Vaccination with live attenuated vaccines, inactivate vaccines or RNA vaccines within 4 weeks prior to informed consent; 10. Participants who are allergic or intolerant to preconditioning drugs, tocilizumab, or allergic to the components (DMSO) in CT1190B cell infusion preparation; or have other previous history of severe allergy such as anaphylactic shock; 11. Participants with any of the following cardiac conditions within 6 months prior to screening: 1\) New York Heart Association (NYHA) Class III or IV heart failure; 2) Myocardial infarction, coronary artery bypass graft surgery, or unstable angina within 6 months before screening; 3) History of clinically significant uncontrolled arrhythmia, e.g., ventricular arrhythmia; 4) History of severe non-ischemic cardiomyopathy; 5) Left ventricular ejection fraction (LVEF) \< 45% as assessed by echocardiogram or multimodal acquisition (MUGA) scan; 6) Other cardiac diseases that, in the opinion of the investigator, may jeopardize the participant 's well-being due to participation in this clinical study; 12. Oxygen saturation \< 92%, or suffering from other serious lung diseases, which may endanger the participant 's life as judged by the investigator; 13. Presence of a second primary malignancy requiring treatment or not in complete remission within the past 2 years, except for the following successfully treated tumors with low malignancy such as non-metastatic basal cell or squamous cell skin cancer, non-metastatic prostate cancer, breast or cervical carcinoma in situ, non-muscle-invasive bladder cancer, or thyroid cancer; 14. Major surgery within 2 weeks before informed consent or planned during the study period or within 4 weeks after giving study treatment (excluding local anesthesia such as cataract); 15. Participants are unable or unwilling to comply with the requirements of the study protocol or are otherwise unsuitable for participating in this clinical study in the investigator 's assessment,;

Treatments Being Tested

DRUG

CAR T cells

chimeric antigen receptor T cells

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Wuhang, Hubei, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07053670), the sponsor (Tongji Hospital), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07053670 clinical trial studying?

A Clinical Study to Investigate the Safety, Efficacy, and Cellular Metabolism of CT1190B CAR-T Cell therapy, in Patients with Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07053670?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07053670?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07053670. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07053670. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.