B-Cell Non-Hodgkin LymphomaPhase 1CT1190BNCT06822868
A Clinical Study Exploring CT1190B in the Treatment of Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
A Phase 1 study testing CAR T cells in people with B-Cell Non-Hodgkin Lymphoma, run by Kai Hu at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- B-Cell Non-Hodgkin Lymphoma
- What is being tested?
- CAR T cells
- 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
- 10 Feb 2025to 30 Sep 2026
- 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
- 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.
- 18-75 years old;
- Histologically or cytologically confirmed B-NHL;
- Previously received at least 2 lines of systemic therapy;
- Intolerance to last treatment, or have progressed on or after the last treatment and currently require therapy;
- There are measurable target lesions;
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- Expected survival > 12 weeks;
- Eastern Cooperative Oncology Group (ECOG) score 0-1;
- 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.
Who cannot join
- Pregnant or lactating women;
- 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);
- Has any current uncontrolled active infection, including but not limited to participants with active tuberculosis (investigator 's judgment);
- 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;
- 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;
- Systemic glucocorticoids equivalent to > 15 mg/day prednisone within 7 days prior to informed consent, with the exception of topical glucocorticoids;
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- Vaccination with live attenuated vaccines, inactivate vaccines or RNA vaccines within 4 weeks prior to informed consent;
- Participants who are allergic or intolerant to preconditioning drugs, tocilizumab, or have other previous history of severe allergy such as anaphylactic shock;
- Patients with any heart disease in the 6 months prior to screening;
- Oxygen saturation < 92%,;
- Presence of a second primary malignancy requiring treatment or not in complete remission within the past 2 years;
- 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);
- 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;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing GoBroad Hospital
Beijing, Beijing Municipality, 102200
Kai Hu MD, 15010390336, huk@gobroadhealthcare.com
Kai Hu MD
About this study
Official title: 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 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.
- Conditions
- B-Cell Non-Hodgkin Lymphoma
- Being tested
- CAR T cells
- Keywords
- CT1190B
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR T cellsDrug
chimeric antigen receptor T cells
| Study group | Role | What they receive |
|---|---|---|
| CAR-T cells（ chimeric antigen receptor T cells） | Experimental | CT1190B cells infusion Receives: Drug: CAR T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AE) after CT1190B infusion
An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria
Measured: 12 months after CT1190B infusion
MTD and/or dose range
Evaluate Dose limited toxicity and recommended dosage range after CT0991 infusion.
Measured: Up to 28 days after CAR-T cells infusion
Secondary outcomes (7)
Overall response rate（ORR）
The proportion of patients with complete remission （CR） /partial response (PR) after CT1190B infusion.
Measured: Evaluate at 4, 8, 12 weeks and 6,9,12month after CAR-T infusion
Complete response rate (CRR)
The proportion of patients with complete response(CR) after CT1190B infusion
Measured: 12 months after CT1190B infusion
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.
Measured: 12 months after CT1190B infusion
Time to response (TTR)
The time from cell infusion to the first assessment of CR or PR
Measured: 12 months after CT1190B infusion
Time to complete response (TTCR)
The time from cell infusion to the first assessment of CR
Measured: 12 months after CT1190B infusion
Progression-free survival (PFS)
The time from the infusion of CT1190B cells to the first assessment of disease progression or death.
Measured: 12 months after CT1190B infusion
Overall survival (OS)
defined as the time from the date of receiving the infusion to the date of death from any cause
Measured: 12 months after CT1190B infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start10 Feb 2025 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-Cell Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kai Hu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kai Hu, Beijing GoBroad Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06822868
- Sponsor's protocol ID
- CT1190B-CG11001_04
- Acronym
- CT1190B
- Status last verified
- Feb 2025
- First submitted
- 5 Feb 2025
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06822868
- Acronym / sponsor ID
- CT1190B / CT1190B-CG11001_04
- Conditions
- B-Cell Non-Hodgkin Lymphoma
- Keywords
- CT1190B
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Kai HuUniversity, hospital or other
- Study start
- 10 Feb 2025 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 12 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAR-T cells（ chimeric antigen receptor T cells） | Experimental | Drug: CAR T cellsCT1190B cells infusion |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- 18-75 years old;
- Histologically or cytologically confirmed B-NHL;
- Previously received at least 2 lines of systemic therapy;
- Intolerance to last treatment, or have progressed on or after the last treatment and currently require therapy;
Key exclusion criteria (13 listed)
- Pregnant or lactating women;
- 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);
- Has any current uncontrolled active infection, including but not limited to participants with active tuberculosis (investigator 's judgment);
- 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;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAR T cellschimeric antigen receptor T cells | Drug | CAR-T cells（ chimeric antigen receptor T cells） |
Primary outcome
Adverse Events (AE) after CT1190B infusion
Time frame: 12 months after CT1190B infusion
An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria
MTD and/or dose range
Time frame: Up to 28 days after CAR-T cells infusion
Evaluate Dose limited toxicity and recommended dosage range after CT0991 infusion.
7 secondary outcomes
Overall response rate（ORR）
Time frame: Evaluate at 4, 8, 12 weeks and 6,9,12month after CAR-T infusion
Complete response rate (CRR)
Time frame: 12 months after CT1190B infusion
Duration of remission(DOR)
Time frame: 12 months after CT1190B infusion
Time to response (TTR)
Time frame: 12 months after CT1190B infusion
Time to complete response (TTCR)
Time frame: 12 months after CT1190B infusion
Progression-free survival (PFS)
Time frame: 12 months after CT1190B infusion
Overall survival (OS)
Time frame: 12 months after CT1190B infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CAR T cells in people with B-Cell Non-Hodgkin Lymphoma, run by Kai Hu 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 9 inclusion and 13 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 12 Feb 2025. 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 Kai Hu MD (15010390336, huk@gobroadhealthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (AE) after CT1190B infusion (time frame: 12 months after CT1190B 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?
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 12 Feb 2025.