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

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

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.

Study Overview

• Status: Recruiting
• Conditions: B-Cell Non-Hodgkin Lymphoma
• Intervention / Treatment: Drug: CAR T cells

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.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Aibin Liang MD，Ph.D.; Phone Number: +86 21 6611 1019; Email: lab7182@tongji.edu.cn
• Study Contact Backup: Name: Ping Li MD; Phone Number: +86 135 6418 1131; Email: lilyforever@126.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200065
      • Recruiting
      • Shanghai Tongji Hospital
      • Contact: Aibin Liang MD，Ph.D.; Phone Number: +86 21 6611 1019; Email: lab7182@tongji.edu.cn
      • Contact: Ping Li MD; Phone Number: +86 135 6418 1131; Email: lilyforever@126.com
      • Contact: Aibin Liang MD,Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CAR-T cells（ chimeric antigen receptor T cells）; CT1190B cells infusion	Drug: CAR T cells; chimeric antigen receptor T cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MTD and/or dose range	Evaluate Dose limited toxicity and recommended dosage range after CT0991 infusion	Up to 28 days after CAR-T cells infusion
Adverse Events (AE) after CT1190B infusion	An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria	12 months after CT1190B infusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall response rate（ORR）	The proportion of patients with complete remission （CR） /partial response (PR) after CT1190B infusion.	Evaluate at 4, 8, 12 weeks and 6,9,12month after CAR-T infusion
Complete response rate (CRR)	The proportion of patients with complete response(CR) after CT1190B infusion	12 months after CT1190B infusion
Duration of remission(DOR)	Participants achieving CR/PR will be included in the analysis set for DOR. DOR is defined as the time from the date of confirmed response until the date of disease relapse or death from any cause, whichever occurs first.	12 months after CT1190B infusion
Time to response (TTR)	The time from cell infusion to the first assessment of CR or PR	12 months after CT1190B infusion
Time to complete response (TTCR)	The time from cell infusion to the first assessment of CR	12 months after CT1190B infusion
Progression-free survival (PFS)	The time from the infusion of CT1190B cells to the first assessment of disease progression or death.	12 months after CT1190B infusion
Overall survival (OS)	defined as the time from the date of receiving the infusion to the date of death from any cause	12 months after CT1190B infusion

Collaborators and Investigators

• Sponsor: Aibin Liang，MD，Ph.D.
• Investigators: Principal Investigator: Aibin Liang MD,Ph.D., Shanghai Tongji Hospital, Tongji University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2024
• Primary Completion (Estimated): October 13, 2025
• Study Completion (Estimated): July 13, 2026

Study Registration Dates

• First Submitted: December 11, 2024
• First Submitted That Met QC Criteria: December 11, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 2, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: CT1190B
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin
• Other Study ID Numbers: CT1190B-CG11001_02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No