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

NCT07068906 | Not Yet Recruiting Phase 1

• 1 other identifier: IIT2025069
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

B-Cell Non-Hodgkin Lymphoma

Keywords

CT1194C

Outcome Measures

Primary Outcomes (2)

• Adverse Events (AE) after CT1194C infusion

  An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria

  12 months after CT1194C infusion

• MTD and/or dose range

  Evaluate Dose limited toxicity and recommended dosage range after CT1194C infusion

  Up to 28 days after CAR-T cells infusion

Secondary Outcomes (7)

• Overall response rate （ORR）

  Evaluate at 4, 8, 12 weeks and 6,9,12month after CAR-T infusion

• Complete response rate (CRR)

  12 months after CT1194C infusion

• Duration of remission(DOR)

  12 months after CT1194C infusion

• Time to response (TTR)

  12 months after CT1194C infusion

• Time to complete response (TTCR)

  12 months after CT1194C infusion

Study Arms (1)

CAR-T cells chimeric antigen receptor T cells

EXPERIMENTAL

Drug: CAR-T cells chimenric antigen receptor T cells

Interventions

CAR-T cells chimenric antigen receptor T cells DRUG

CT1194C cells infusion

CAR-T cells chimeric antigen receptor T cells

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

China Institute of Hematology and Blood Diseases Hospital

Tianjin, 300020, China

Location

MeSH Terms

Conditions

Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Liang Huang

CONTACT

13971600192; huangliang@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 16, 2025
• Study Start: July 15, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 16, 2025

Record last verified: 2025-06

Locations

CN (1)