Study of TQB2303 in Patients With Aggressive CD20 Positive Non-Hodgkin's Lymphoma

A Multi-center, Randomized, Double-blind, Parallel Control Clinical Trial to Assess the Similarity of the Safety and Pharmacokinetics of TQB2303 in Combination With Rituximab to Patients With AggressiveCD20 Positive Non-Hodgkin's Lymphoma

Primary Outcome Measures:

Area under the curve (AUC) forTQB2303 and rituximab concentrations [ Time Frame: 85 days ]

Secondary Outcome Measures:

The Maximum Concentration (Cmax) of the TQB2303 and rituximab [ Time Frame: 85 days ] The area under the plasma concentration-time curve from 0 to inf (infinite) time (AUC0-∞); The time to reach the maximum plasma concentration after treatment (Tmax) Total clearance (CL); Elimination of half-life (t1 / 2); Apparent distribution volume (Vd).

Study Overview

• Status: Unknown
• Conditions: Non-hodgkin's Lymphoma
• Intervention / Treatment: Drug: TQB2303; Drug: Rituximab

• Study Type: Interventional
• Enrollment (Anticipated): 122
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Recruiting
      • Jiangsu Cancer Hospital
      • Contact: Jifeng feng, doctor; Phone Number: 025-83233303; Email: fjif@vip.sina.com
    • Suzhou, Jiangsu, China, 215006
      • Recruiting
      • First Affiliated Hospital of Suzhou University
      • Contact: Depei wu, doctor; Phone Number: 0512-67780040; Email: drwudepei@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients should participate in the study voluntarily and sign informed consent;
2. CD20-positive non-Hodgkin's lymphoma (NHL)：Diffuse Large B-cell Lymphoma；Mantle Cell Lymphoma；Follicular Lymphoma；Marginal Zone Lymphoma;
3. having obtained CR (complete remission) or CRu (uncertain complete remisson) after the prior therapy;And the investigators believe that CD20-positive B-cell NHL patients can benefit from anti-CD20 monoclonal antibody therapy;
4. aged from 18 to 75 years;
5. ECOG PS:0-1；
6. Life expectancy of more than 3 months

Exclusion Criteria:

1. Had received rituximab or other anti-CD20(+) monoclonal antibody treatment within 1 year before enrollment;
2. patients who were treated with antitumor therapy (including corticosteroid therapy) within 4 weeks prior to enrollment, or who had not recovered from the toxicity of the previous treatment;
3. Patients who participated in other clinical studies within 30 days ;
4. Serious hematologic dysfunction (white blood cell count of <3.0×10^9/L; absolute neutrophil count of <1.5×10^9/L; platelet count of < 75×10^9/L; hemoglobin level of <80g/L); In the absence of anticoagulant therapy, International Standardization Ratio (INR)> 1.5× ULN;Partial prothrombin time (PTT)Or activated partial thromboplastin time (aPTT)> 1.5 × ULN;) Hepatic dysfunction (total bilirubin level of > 1.5 × upper limit of normal (ULN); aspartate amino transferase (AST) and alanine amino transferase (ALT) levels of > 2.0 × ULN;) renal dysfunction (serum creatinine level of > 1.5×ULN );
5. Other invasive malignancies except for cured the IB or lower level of cervical cancer; Non-invasive basal cells or squamous cell skin cancer; Get CR> 10 years of breast cancer;Get CR> 10 years of malignant melanoma;or other malignancies with CR> 5 years;
6. Central nervous system (CNS) lymphoma, AIDS-associated lymphoma;
7. Active infections and other serious non-malignant tumor diseases, Such as Qualitative pneumonia, Severe organic cardiovascular disease, Heart conduction block > 2,Myocardial infarction in 6 months, Cerebral infarction in 3 months,Cerebral hemorrhage,Thyroid dysfunction (TSH lower than the normal lower limit or higher than the upper limit of normal, and the researchers have a clinical significance);

8. Seropositive for HIV , HCV antibody; Or one of the following HBV findings :

   1. HBsAg positive;
   2. HBsAg negative, HBcAb positive and HBV DNA positive;
9. Plan major surgery, or surgical wound unhealed patients;
10. History of severe allergies, protein products and mouse products such as allergies;
11. Pregnancy or breast feeding. Companion for women of childbearing age or women of childbearing age,who reluctant to take appropriate contraceptive methods within one year after the last treatment of the study;Pregnancy before pregnancy screening, the women who blood / urine results were positive;
12. Receipt of a live/attenuated vaccine within 4 weeks prior to the Screening Visit;
13. Researchers think that do not fit into the group.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Rituximab	Drug: Rituximab; 375mg/m2 ，iv
EXPERIMENTAL: TQB2303	Drug: TQB2303; 375mg/m2 ，iv

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC	Area under the curve (AUC) forTQB2303 and rituximab concentrations	85 days
Cmax	The Maximum Concentration (Cmax) of the TQB2303 and rituximab	85 days
AUC0-∞	The area under the plasma concentration-time curve from 0 to inf (infinite) time	85 days
Tmax	The time to reach the maximum plasma concentration after treatment	85 days
CL	Total clearance	85 days
t1/2	Elimination of half-life	85 days
Vd	Apparent distribution volume	85 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of immunogenicity	Anti-drug antibody (ADA), neutralizing antibody (Nab detection when ADA positive)	85 days
Change of CD19+ CD20+ B-cells from baseline	Change of CD19+ CD20+ B-cells from baseline	85 days

Collaborators and Investigators

• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2017
• Primary Completion (ANTICIPATED): June 30, 2018
• Study Completion (ANTICIPATED): June 30, 2018

Study Registration Dates

• First Submitted: December 23, 2017
• First Submitted That Met QC Criteria: March 5, 2018
• First Posted (ACTUAL): March 7, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 7, 2018
• Last Update Submitted That Met QC Criteria: March 5, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Lymphoma, Non-Hodgkin; Physiological Effects of Drugs; Antirheumatic Agents; Antineoplastic Agents; Immunologic Factors; Antineoplastic Agents, Immunological; Rituximab
• Other Study ID Numbers: TQB2303-I-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No