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Not yet recruitingNCT07032324CT1190BUpdated Jun 23, 2025

A Clinical Study Exploring CT1190B in the Treatment of Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma ( CT1190B-CG1101 )

A Phase 1 interventional study of CAR T cells in B-Cell Non-Hodgkin Lymphoma, sponsored by Qian Wenbin. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-06-23.

Sponsored by Qian Wenbin · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 1
Study type
Interventional
Enrollment
27
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

Read the detailed description

This is a single-arm, open-label, dose exploratory clinical study to evaluate the safety, efficacy, cellular pharmacokinetics, and pharmacodynamics of CT1190B cells in patients with B-NHL. It is planned to enroll 6-24 participants.

02

Conditions studied

  • B-Cell Non-Hodgkin Lymphoma

Keywords

  • CT1190B
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 27 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Qian Wenbin is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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; 4. Previous treatment requirement: 5) 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.
  1. 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; 7) 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; 8) 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
  1. Intolerance to last treatment, or have progressed on or after the last treatment and currently require therapy.
  1. At least one of the following:
  1. CT testing: Intranodal lesions > 1.5 cm in long diameter, or Extranodal lesions > 1.0 cm in long diameter, 2) PETCT 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; 9. Participants should meet the following test results
  1. CBC: ① platelet (PLT) ≥ 75 × 10 9/L (for participants with bone marrow or peripheral blood involvement: PLT ≥ 50 × 10 9/L), ②hemoglobin (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.
  1. 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

Exclusion Criteria:

  1. Pregnant or lactating women;
  2. Has HIV, syphilis infection, active hepatitis B virus infection (HBsAg positive and 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 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
27 participants (estimated)

Study arms

  • Experimental
    CAR-T cells( chimeric antigen receptor T cells)

    CT1190B and CT1190B-P cells infusion

    Drug: CAR T cells

Interventions

  • DrugCAR T cells

    chimeric antigen receptor T cells

06

What researchers measure

Primary outcomes

  1. Adverse Events (AE) after CT1190B/CT1190B-P infusion

    An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria.

    Time frame: 12 months after CT1190B/CT1190B-P infusion

  2. MTD and/or dose range

    Evaluate Dose limited toxicity and recommended dosage range after CT1190b/CT1190b-p infusion

    Time frame: Up to 28 days after CAR-T cells infusion

Secondary outcomes

  1. Overall response rate#ORR#

    The proportion of patients with complete remission #CR# /partial response (PR) after CT1190B/CT1190B-P infusion.

    Time frame: Evaluate at 4, 8, 12 weeks and 6,9,12month after CAR-T infusion]

  2. Complete response rate (CRR)

    The proportion of patients with complete response(CR) after CT1190B/CT1190B-P infusion

    Time frame: 12 months after CT1190B/CT1190B-P infusion

  3. Duration of remission(DOR)

    Participants achieving CR/PR will be included in the analysis set for DOR. DOR is defined as the time from the date of confirmed response until the date of disease relapse or death from any cause, whichever occurs first.

    Time frame: 12 months after CT1190B infusion

  4. Progression-free survival (PFS)

    The time from the infusion of CT1190B cells to the first assessment of disease progression or death.

    Time frame: 12 months after CT1190B infusion

  5. Overall survival (OS)

    defined as the time from the date of receiving the infusion to the date of death from any cause.

    Time frame: 12 months after CT1190B infusion.

07

Study locations

1 site
  • Second Affiliated Hospital, School of Medicine, Zhejiang University
    Hangzhou, Zhejiang 310003, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07032324
Lead sponsor
Qian Wenbin
Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Responsible party
Qian Wenbin (Principal Investigator, Second Affiliated Hospital, School of Medicine, Zhejiang University) — Sponsor-investigator
First posted
Jun 23, 2025
Start date
Jul 8, 2025 (estimated)
Primary completion
Dec 30, 2025 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Jun 23, 2025

Study contacts

Qian Wenbin MD
Contact
Qianwb@zju.edu.cn
+86-0571-89713672
Qian wenbin MD, Ph.D
Contact
Qianwb@zju.edu.cn
+86-0571-89713672
qian wenbin MD
principal investigator · Second Affiliated Hospital, School of Medicine, Zhejiang University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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