Exploring CT1190B for treating relapsed 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

This study is testing a new CAR-T cell therapy called CT1190B to see if it can safely help people with relapsed B-cell Non-Hodgkin Lymphoma.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Beijing GoBroad Hospital (other)
• Drugs / interventions: tocilizumab, radiation, prednisone, CAR-T
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06822868 on ClinicalTrials.gov

What this trial studies

This clinical study investigates the safety and efficacy of CT1190B CAR-T cell therapy in patients with relapsed or refractory B-cell Non-Hodgkin Lymphoma. It is a single-arm, open-label, dose exploratory study that aims to evaluate the cellular pharmacokinetics and pharmacodynamics of the treatment. The study plans to enroll between 6 to 24 participants who meet specific eligibility criteria, including prior treatment history and measurable disease. Participants will be monitored for long-term outcomes as part of the study protocol.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with histologically confirmed relapsed or refractory B-cell Non-Hodgkin Lymphoma who have received at least two prior lines of systemic therapy.

Not a fit: Patients who have not received prior systemic therapy or those with an ECOG score greater than 1 may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat B-cell Non-Hodgkin Lymphoma.

How similar studies have performed: Other studies using CAR-T cell therapy for B-cell Non-Hodgkin Lymphoma have shown promising results, indicating potential for success in this approach.

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.
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;

Where this trial is running

Beijing, Beijing Municipality

• Beijing GoBroad Hospital — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Kai Hu MD

Conditions: B-Cell Non-Hodgkin Lymphoma, CT1190B