- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05091541
A Phase 1/2 Study of CT120 in Patient With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma
A Multicenter Phase I/II Clinical Study on Fully Human Anti-CD19/CD22 Dual Target Chimeric Antigen Receptor Autologous T Cell Injection (CT120) for the Treatment of Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Ming Wu
- Phone Number: +86 0531-58287610
- Email: ming.wu@iasobio.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age between 18 and 70 years old.
- Pathologically confirmed B-cell non-Hodgkin's lymphoma, including:
(1) Diffuse large B-cell lymphoma (DLBCL); (2) Histopathological Grade 3b follicular lymphoma (FL3b); (3) Follicular lymphoma with diffuse large B cell transformation; (4) Primary mediastinal large B-cell lymphoma (PMBCL). 3. Relapsed/refractory B-cell non-Hodgkin's lymphoma must meet one of the following criteria:
- At least 2 failed prior B-cell non-Hodgkin's lymphoma treatment regimens (including relapse, no response, and progression). Prior therapy must have included anti-CD20 monoclonal antibodies (except for CD20-negative subjects) and standard therapies which including anthracyclines;
- Recurrence after autologous hematopoietic stem cell transplantation;
- Primary resistance: After 2 cycles of initial anti-CD20 monoclonal immunochemotherapy, the best response was stable disease or disease progression.
4. At least 1 measurable lesion as following:
- The long axis of the lymph node lesions should be ≥15mm (and the length of the short axis is measurable), or;
- The lengths of extra-lymph node lesions should be ≥10mm in both the long and short axis.
5. Expected survival time≥12 weeks. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 7. Adequate organ function before enrollment, and meet all the following laboratory test results:
- Blood routine: neutrophils ≥1.0 ×109/L (granulocyte colony stimulating factor (G-CSF) is allowed within 7 days before the examination), lymphocytes ≥0.3 ×109 /L, platelets ≥50 ×109 /L (must have not received blood transfusion [including component transfusion] or treatments that include thrombopoietin [TPO] for the purpose of raising platelets within 7 days before the examination), hemoglobin ≥80g/L (must have not received blood transfusion [including component blood transfusion] within 7 days before the examination);
- Blood coagulation function: fibrinogen≥1.0g/L; activated partial thromboplastin time≤1.5×ULN, prothrombin time (PT)≤1.5×ULN;
- Liver function: ALT and AST≤2.5×ULN; serum total bilirubin≤1.5×ULN;
- Renal function: creatinine clearance rate CrCl ≥60 mL/min estimated by Cockcroft-Gault;
- Left ventricular ejection fraction (LVEF)≥50% estimated by echocardiography;
- Baseline oxygen saturation > 91% on room air. 8. Females and males with childbearing potential should take effective contraception from the day of signing the informed consent form to 365 days after the CT120 infusion. Effective contraception is defined as: abstinence or contraceptive methods with an annual failure rate of <1% indicated in section 9.8 of this protocol.
9. Subject is willing to participate in this trial and sign an informed consent form.
Exclusion Criteria:
- Subjects who have received or require the following treatments:
(1) Prior CAR-T cell therapy before enrollment; (2) Presence of acute or chronic graft-versus-host disease (GVHD) requires systemic treatment within 4 weeks before enrollment; (3) History of immunodeficiency or other diseases and autoimmune diseases (eg Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, etc.) received immunosuppressive therapy within 2 years before enrollment; (4) Autologous hematopoietic stem cell transplantation (autoSCT) within 12 weeks before enrollment and history of allogeneic stem cell transplantation (HSCT); (5) Live vaccines injection within 4 weeks before enrollment; (6) According to investigator's discretion, there is a need to use systemic corticosteroid therapy within 12 weeks after the administration of the study drug (except for hydrocortisone ≤12mg/m2/day or other hormones converting into the same dose range for physiological replacement therapy) or other immunosuppressive drug therapy (except local therapy).
2. B-cell non-Hodgkin's lymphoma patients with active central nervous system or intestinal parenchyma invasion.
3. Excessive tumor burden and any lesions with a long axis ≥10cm. 4. Other active malignant tumors in the past 5 years, except for curable tumor that has been completely cured, such as basal or squamous cell carcinoma, cervical or breast carcinoma in situ, etc.
5. Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and an abnormal HBV DNA result detected by peripheral blood test (abnormal HBV DNA result is defined as: the quantitative detection of HBV DNA is over the detectable lower limit or beyond the normal reference of the testing center or HBV viral DNA positive); Hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive; Human immunodeficiency virus (HIV) antibody positive; Cytomegalovirus (CMV) DNA test positive; syphilis test positive.
6. Uncontrollable active infections (except for genitourinary system infections and upper respiratory tract infections < CTCAE Grade 2).
7. Severe heart disease: including but not limited to unstable angina, myocardial infarction (within 6 months before screening), congestive heart failure (New York Heart Association [NYHA] classification ≥ Grade III), severe arrhythmia.
8. Hypertension that cannot be controlled by medication. 9. Adverse events during prior therapies have not relieved to baseline or ≤1 (according to NCI-CTCAE v5.0, except for alopecia).
10. Major surgery within 2 weeks before enrollment, or surgeries that were planed while waiting for infusion or within 12 weeks after receiving investigational product (except planned local anesthesia surgery).
11. History of organ transplant. 12. Pregnant or lactating women. 13. Previous central nervous system diseases (such as cerebral aneurysm, epilepsy, stroke, Alzheimer's disease, mental illness, etc.) or mental disorders.
14. Unstable systemic diseases judged by other researchers: including but not limited to severe liver, kidney, or metabolic diseases that require medication.
15. Other unsuitable situations for enrollment judged by investigators.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CT120 in relapsed/refractory B-cell non-Hodgkin's lymphoma patients
Fully Human Anti-CD19/CD22 Dual Target Chimeric Antigen Receptor Autologous T Cell Injection(CT120)will be infused at 1.0 x 10^6 CAR+ T cells/kg、3.0 x 10^6 CAR+ T cells/kg、6.0 x 10^6 CAR+ T cells/kg in relapsed/refractory B-cell non-Hodgkin's lymphoma patients
|
CT120 is an autologous CD19/22 targeted CAR-T cells injection.
The dosage form is a cryopreserved injection solution.
The T cells aphesis from subjects then been manufactured to express CAR to binding CD19 and CD22 on B-cell lymphoma.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Phase 1: Types and incidence of Dose-limiting toxicity (DLT)
Time Frame: up to 28 days after CT120 infusion
|
Dose-limiting toxicity (DLT) will be collected and graded according to American Society for Transplantation and Cellular Therapy (ASTCT) consensus (for CRS/ICANS) and CTCAE v5.0(for AE except CRS/ICANS)
|
up to 28 days after CT120 infusion
|
Phase 1:Types and incidence of adverse events (AEs) ,serious adverse events (SAEs) and adverse events of special interest (AESI)
Time Frame: Up to 2 years after CT120 CAR T-cells infusion
|
AE will be collected and graded according to American Society for Transplantation and Cellular Therapy (ASTCT) consensus (for CRS/ICANS) and CTCAE v5.0(for AE except CRS/ICANS)
|
Up to 2 years after CT120 CAR T-cells infusion
|
Phase 2:Overall response rate (ORR) at Day 90
Time Frame: Up to 90 Days after CT120 infusion
|
ORR will be calculated as the percentage of patients who achieved partial response (PR) or better at Day 90
|
Up to 90 Days after CT120 infusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall response rate (ORR)
Time Frame: Up to Day 28、Day 90、Day180 after CT120 infusion
|
ORR will be calculated as the percentage of patients who achieved partial response (PR) or better.
|
Up to Day 28、Day 90、Day180 after CT120 infusion
|
Time to Response (TTR)
Time Frame: Up to 2 years after CT120 infusion
|
Time from CT120 infusion to first documentation of response.
|
Up to 2 years after CT120 infusion
|
Time to complete Response (TTCR)
Time Frame: Up to 2 years after CT120 infusion
|
Time from CT120 infusion to first documentation of complete response.
|
Up to 2 years after CT120 infusion
|
Duration of Response (DOR)
Time Frame: Up to 2 years after CT120 infusion
|
Time from first response to disease progression or death from any cause
|
Up to 2 years after CT120 infusion
|
Progression-free Survival (PFS)
Time Frame: Up to 2 years after CT120 infusion
|
PFS will be calculated as the time from CT120 infusion to disease progression or death from any cause (whichever occurs first).
|
Up to 2 years after CT120 infusion
|
Overall Survival (OS)
Time Frame: Up to 2 years after CT120 infusion
|
Time from CT120 infusion to time of death due to any cause
|
Up to 2 years after CT120 infusion
|
Quantity of CAR copies in peripheral blood
Time Frame: Up to 2 years after CT120 infusion
|
CAR copies in peripheral blood will be measured by quantitative polymerase chain reaction (qPCR) in 2 years.
|
Up to 2 years after CT120 infusion
|
Quantity of CAR T-cells level in peripheral blood
Time Frame: Up to 2 years after CT120 infusion
|
CAR T-cells in peripheral blood will be measured by flow cytometry (FCM) in 2 years
|
Up to 2 years after CT120 infusion
|
Laboratory tests
Time Frame: Up to 2 years after CT120 infusion
|
Abnormal results of laboratory tests
|
Up to 2 years after CT120 infusion
|
Vital signs
Time Frame: Up to 2 years after CT120 infusion
|
Abnormal results of vital signs
|
Up to 2 years after CT120 infusion
|
Physical examination
Time Frame: Up to 2 years after CT120 infusion
|
Abnormal results of physical examination
|
Up to 2 years after CT120 infusion
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immunogenicity
Time Frame: Up to 2 years after CT120 infusion
|
Development of an anti-CAR antibody response
|
Up to 2 years after CT120 infusion
|
Replication competent lentivirus (RCL)
Time Frame: Up to 15 years after CT120 infusion
|
The incidence of replication competent lentivirus (RCL)
|
Up to 15 years after CT120 infusion
|
Changes in the proportion of peripheral blood lymphocyte subsets
Time Frame: Up to 2 years after CT120 infusion
|
Changes in the proportion of lymphocyte subsets in the peripheral blood will be analyzed by immune cell phenotyping using flow cytometry.
|
Up to 2 years after CT120 infusion
|
Correlation between cytokines/inflammation-related proteins and Incidence of Adverse Event
Time Frame: Up to 2 years after CT120 infusion
|
Up to 2 years after CT120 infusion
|
|
Correlation between cytokines/inflammation-related proteins and efficacy
Time Frame: Up to 2 years after CT120 infusion
|
Up to 2 years after CT120 infusion
|
|
Correlation between efficacy and CD19/CD22 antigen expression in tumor tissues
Time Frame: Up to 2 years after CT120 infusion
|
Up to 2 years after CT120 infusion
|
|
Correlation between efficacy and gene mutations including MYC, BCL2 and BCL6 rearrangements
Time Frame: Up to 2 years after CT120 infusion
|
Up to 2 years after CT120 infusion
|
|
Correlation between efficacy and and the expression of oncogenes including C-myc and BCL
Time Frame: Up to 2 years after CT120 infusion
|
Up to 2 years after CT120 infusion
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CT120C001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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