Not yet recruiting NCT07068906
A Clinical Study Exploring CT1194C in Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CAR-T cells chimenric antigen receptor T cells.
- Who it may be relevant to
- Registry conditions: B-Cell Non-Hodgkin Lymphoma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Clinical Study to Investigate the Safety, Efficacy, and Cellular Metabolism of CT1194C 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 CT1194C CAR-T Cell therapy, in Patients with Relapsed/Refractory B-Cell NonHodgkin Lymphoma.
Detailed description
This is a single-arm, open-label, dose exploratory clinical study to evaluate the safety, efficacy, cellular pharmacokinetics, and pharmacodynamics of CT1194C cells in patients with B-NHL. It is planned to enroll 3-27 participants.
Interventions
- Drug CAR-T cells chimenric antigen receptor T cells
CT1194C cells infusion
Primary outcome measures
- Adverse Events (AE) after CT1194C infusion [Time frame: 12 months after CT1194C 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 CT1194C infusion]
- Duration of remission(DOR) [Time frame: 12 months after CT1194C infusion]
- Time to response (TTR) [Time frame: 12 months after CT1194C infusion]
- Time to complete response (TTCR) [Time frame: 12 months after CT1194C infusion]
- Progression-free survival (PFS) [Time frame: 12 months after CT1194C infusion]
- Overall survival (OS) [Time frame: 12 months after CT1194C 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
- 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。Both male and Female 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 sperm donation or eggs for 1 year after receiving study treatment infusion during the study;
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
- China Institute of Hematology and Blood Diseases Hospital — Tianjin
Identifiers
NCT: NCT07068906 · IIT2025069