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

NCT06734871 | Recruiting Phase 1

• 1 other identifier: CT1190B-CG11001_02
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

B-Cell Non-Hodgkin Lymphoma

Keywords

CT1190B

Outcome Measures

Primary Outcomes (2)

• 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

• 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

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 CT1190B infusion

• Duration of remission(DOR)

  12 months after CT1190B infusion

• Time to response (TTR)

  12 months after CT1190B infusion

• Time to complete response (TTCR)

  12 months after CT1190B infusion

Study Arms (1)

CAR-T cells（ chimeric antigen receptor T cells）

EXPERIMENTAL

CT1190B cells infusion

Drug: CAR T cells

Interventions

CAR T cells DRUG

chimeric antigen receptor T cells

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 and agree to be in long term follow-up (LTFU) for up to 15 years as mandated by the regulatory guidelines.
• 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.

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

• Aibin Liang，MD，Ph.D.: lead

Study Sites (1)

Shanghai Tongji Hospital

Shanghai, Shanghai Municipality, 200065, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell

Interventions

Immunotherapy, Adoptive

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

Intervention Hierarchy (Ancestors)

Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Study Officials

• Aibin Liang MD,Ph.D.

  Shanghai Tongji Hospital, Tongji University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aibin Liang MD,Ph.D.

CONTACT

+86 21 6611 1019; lab7182@tongji.edu.cn

Ping Li MD

CONTACT

+86 135 6418 1131; lilyforever@126.com

Study Design

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

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 16, 2024
• Study Start: December 30, 2024
• Primary Completion: October 13, 2025
• Study Completion (Estimated): July 13, 2026
• Last Updated: January 3, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)