A Clinical Study Exploring CT1190B in the Treatment of Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
Recruiting
Phase 1Interventional Study
B-Cell Non-Hodgkin Lymphoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
24 (estimated)
Sponsor
Kai Hu · Other
Who this trial is looking for
This trial is looking for adult patients with relapsed or refractory B-cell non-Hodgkin lymphoma. Participants will receive a special CAR-T cell therapy called CT1190B and follow up for up to 15 years.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 to 75 years old.
I have been diagnosed with B-cell non-Hodgkin lymphoma.
I have tried at least 2 different treatments for my condition.
I need therapy because my last treatment didn’t work or I couldn't tolerate it.
I have measurable lesions as part of my condition.
I expect to live more than 12 weeks.
I have an ECOG score of 0-1.
You may not be able to join if
I am pregnant or breastfeeding.
I have an active infection like HIV, hepatitis B, or hepatitis C.
I have an uncontrolled active infection.
I have not fully recovered from side effects of previous treatments.
I have received treatment for my condition in the last 14 days.
I have taken high doses of steroids in the last week.
I have had major surgery in the last 2 weeks or plan to have one soon.
I have any heart disease in the last 6 months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Eligibility Criteria
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.
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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:
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;
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