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

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

Overview

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.

Interventions

• Drug CAR T cells
  chimeric antigen receptor T cells

Primary outcome measures

• Adverse Events (AE) after CT1190B infusion [Time frame: 12 months after CT1190B infusion]
• MTD and/or dose range [Time frame: Up to 28 days after CAR-T cells infusion]

Secondary outcome measures (7)

• 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]

Eligibility criteria

Inclusion criteria

• 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;
• 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.

Exclusion criteria

• 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;
• 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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Shanghai Tongji Hospital — Shanghai

Identifiers

NCT: NCT06734871 · CT1190B-CG11001_02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗