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RecruitingNCT06822868CT1190BUpdated Feb 12, 2025

A Clinical Study Exploring CT1190B in the Treatment of Patients with Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

A Phase 1 interventional study of CAR T cells in B-Cell Non-Hodgkin Lymphoma, sponsored by Kai Hu. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-02-12.

Sponsored by Kai Hu · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year ago, but the record still lists the study as recruiting.
Phase
Phase 1
Study type
Interventional
Enrollment
24
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 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 24 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Kai Hu 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;
  4. Previously received at least 2 lines of systemic therapy;
  5. Intolerance to last treatment, or have progressed on or after the last treatment and currently require therapy;
  6. There are measurable target lesions;
  7. Expected survival > 12 weeks;
  8. Eastern Cooperative Oncology Group (ECOG) score 0-1;
  9. 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. Has received treatment for the disease within 14 days before informed consent, 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;
  6. Systemic glucocorticoids equivalent to > 15 mg/day prednisone within 7 days prior to informed consent, with the exception of topical glucocorticoids;
  7. Vaccination with live attenuated vaccines, inactivate vaccines or RNA vaccines within 4 weeks prior to informed consent;
  8. Participants who are allergic or intolerant to preconditioning drugs, tocilizumab, or have other previous history of severe allergy such as anaphylactic shock;
  9. Patients with any heart disease in the 6 months prior to screening;
  10. Oxygen saturation \< 92%,;
  11. Presence of a second primary malignancy requiring treatment or not in complete remission within the past 2 years;
  12. 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);
  13. 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
24 participants (estimated)

Study arms

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

    CT1190B 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 infusion

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

    Time frame: 12 months after CT1190B infusion

  2. MTD and/or dose range

    Evaluate Dose limited toxicity and recommended dosage range after CT0991 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 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 infusion

    Time frame: 12 months after CT1190B 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. Time to response (TTR)

    The time from cell infusion to the first assessment of CR or PR

    Time frame: 12 months after CT1190B infusion

  5. Time to complete response (TTCR)

    The time from cell infusion to the first assessment of CR

    Time frame: 12 months after CT1190B infusion

  6. 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

  7. 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 of 1 sites recruiting
  • Beijing GoBroad Hospital
    Beijing, Beijing 102200, China
    Recruiting
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 Feb 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06822868
Lead sponsor
Kai Hu
Responsible party
Kai Hu (Principal Investigator, Beijing GoBroad Hospital) — Sponsor-investigator
First posted
Feb 12, 2025
Start date
Feb 10, 2025 (estimated)
Primary completion
Sep 30, 2025 (estimated)
Completion
Sep 30, 2026 (estimated)
Last update
Feb 12, 2025

Study contacts

Kai Hu MD
Contact
huk@gobroadhealthcare.com
15010390336

Oversight

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

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