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A Clinical Study Exploring CT1194C in Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

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

NCT07068906•Institute of Hematology & Blood Diseases Hospital, China

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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
•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。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

•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%,;
+3 more criteria

Locations (1)

China Institute of Hematology and Blood Diseases Hospital

Tianjin, China

Key Dates

Start Date

July 15, 2025

Primary Completion Date

June 30, 2026

Completion Date

June 30, 2027

Last Updated

July 16, 2025

Enrollment

ESTIMATED participants

Conditions

B-Cell Non-Hodgkin Lymphoma

Interventions

CAR-T cells chimenric antigen receptor T cells

DRUG

Contacts

Liang Huang

CONTACT

13971600192 huangliang@ihcams.ac.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 16, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Clinical Study Exploring CT1194C in Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate MK-1045 (CN201) in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (MK-1045-001/CN201-101)

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