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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Contact
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
-
-
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
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 and agree to be in long term follow-up (LTFU) for up to 15 years as mandated by the regulatory guidelines.
- 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 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:
- 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;
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
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: CAR-T cells( chimeric antigen receptor T cells)
CT1190B cells infusion
|
chimeric antigen receptor T cells
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
MTD and/or dose range
Time Frame: Up to 28 days after CAR-T cells infusion
|
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
Time Frame: 12 months 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
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall response rate(ORR)
Time Frame: Evaluate at 4, 8, 12 weeks and 6,9,12month after CAR-T infusion
|
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)
Time Frame: 12 months after CT1190B infusion
|
The proportion of patients with complete response(CR) after CT1190B infusion
|
12 months after CT1190B infusion
|
|
Duration of remission(DOR)
Time Frame: 12 months after CT1190B infusion
|
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)
Time Frame: 12 months after CT1190B infusion
|
The time from cell infusion to the first assessment of CR or PR
|
12 months after CT1190B infusion
|
|
Time to complete response (TTCR)
Time Frame: 12 months after CT1190B infusion
|
The time from cell infusion to the first assessment of CR
|
12 months after CT1190B infusion
|
|
Progression-free survival (PFS)
Time Frame: 12 months after CT1190B infusion
|
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)
Time Frame: 12 months after CT1190B infusion
|
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
Sponsor
Investigators
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)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- CT1190B-CG11001_02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on B-Cell Non-Hodgkin Lymphoma
-
NCT04637763RecruitingLymphoma | Lymphoma, Non-Hodgkin | B Cell Lymphoma | Non Hodgkin Lymphoma | Refractory B-Cell Non-Hodgkin Lymphoma | Relapsed Non Hodgkin Lymphoma | B Cell Non-Hodgkin's Lymphoma
-
NCT05627245Active, not recruitingRefractory B-Cell Non-Hodgkin Lymphoma | Refractory T-Cell Non-Hodgkin Lymphoma | Recurrent B-Cell Non-Hodgkin Lymphoma | Recurrent Transformed Non-Hodgkin Lymphoma | Recurrent Non-Hodgkin Lymphoma | Refractory Non-Hodgkin Lymphoma | Recurrent T-Cell Non-Hodgkin Lymphoma | Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | Recurrent Follicular Lymphoma | Refractory Follicular Lymphoma
-
NCT06343311RecruitingLymphoma | Lymphoma, Non-Hodgkin | Non-Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | Refractory B-Cell Non-Hodgkin Lymphoma | Refractory Non-Hodgkin Lymphoma | High-grade B-cell Lymphoma | CNS Lymphoma | Lymphomas Non-Hodgkin's B-Cell | Relapsed Non-Hodgkin Lymphoma
-
NCT00992446CompletedFollicular Lymphoma | Mantle Cell Lymphoma | Non-Hodgkin Lymphoma | B-Cell Non-Hodgkin Lymphoma | Adult Diffuse Large B-Cell Lymphoma | T-Cell Non-Hodgkin Lymphoma
-
NCT00860171TerminatedRecurrent Hodgkin Lymphoma | Refractory Hodgkin Lymphoma | Refractory B-Cell Non-Hodgkin Lymphoma | Refractory T-Cell Non-Hodgkin Lymphoma | Recurrent B-Cell Non-Hodgkin Lymphoma | Recurrent T-Cell Non-Hodgkin Lymphoma
-
NCT02106091TerminatedRefractory B-Cell Non-Hodgkin Lymphoma | Relapsed B-Cell Non-Hodgkin Lymphoma
-
NCT05801913RecruitingRefractory B-Cell Non-Hodgkin Lymphoma | Recurrent B-Cell Non-Hodgkin Lymphoma | High Grade B-Cell Non-Hodgkin's Lymphoma | Intermediate Grade B-Cell Non-Hodgkin's Lymphoma
-
NCT06313957RecruitingRelapsed B-cell Non-Hodgkin Lymphoma | Refractory B-cell Non-Hodgkin Lymphoma
-
NCT06618313RecruitingB-Cell Non-Hodgkin Lymphoma-Recurrent | B-Cell Non-Hodgkin Lymphoma-Refractory
-
NCT07188558RecruitingLymphoma, B-Cell | Diffuse Large B Cell Lymphoma Refractory | Non-Hodgkin Lymphoma | Refractory Non-Hodgkin Lymphoma | Large B-cell Lymphoma | Diffuse Large B Cell Lymphoma Relapsed | Relapsed Non-Hodgkin Lymphoma | Diffuse Large B Cell Lymphoma (DLBCL) | Non-Hodgkin Lymphoma Refractory/ Relapsed
Clinical Trials on CAR T cells
-
NCT02737085UnknownLymphoma, Large B-Cell, Diffuse
-
NCT06513429RecruitingRefractory Systemic Lupus Erythematosus
-
NCT02965092UnknownB Cell Lymphoma | Acute Lymphoblastic Leukemia
-
NCT06508775RecruitingPediatric ALL | Melanoma Stage IV | Melanoma Stage III | B-cell Non Hodgkin Lymphoma | Childhood Non-Hodgkin Lymphoma | Chronic Lymphatic Leukemia | Acute Lymphatic Leukemia
-
NCT04049383TerminatedAcute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia, Pediatric | Acute Lymphoblastic Leukemia, in Relapse | Acute Lymphoblastic Leukemia Recurrent | Acute Lymphoblastic Leukemia With Failed Remission | Acute Lymphoblastic Leukemia Not Having Achieved Remission
-
NCT07144020RecruitingAcute Myeloid Leukemia
-
NCT04661020RecruitingLarge B-Cell Lymphoma (LBCL)
-
NCT04657965Not yet recruitingInfectious Diseases | Hematological Malignancies
-
NCT04626908Not yet recruitingRelapsed and Refractory | Lymphoid Hematological Malignancies
-
NCT04532203RecruitingNon-Hodgkin's Lymphoma | Acute Lymphoblastic Leukemia