Study of A-319 in Patients With Relapsed or Refractory B-cell Lymphoma

NCT04056975 | Unknown Phase 1

• 1 other identifier: SP071744
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

Brief Summary

Title: A Phase I, Single Centre, Open-label, Dose-escalation Study of A-319 in Patients With Relapsed or Refractory B-cell Lymphoma

Conditions

Relapsed or Refractory B-cell Lymphoma

Outcome Measures

Primary Outcomes (2)

• Evaluate the Incidence and Characteristics of SAE of A-319 Treat on Relapsed or Refractory B-cell Lymphoma

  Incidence and Characteristics of SAE

  At the end of Cycle 1 (each cycle is 28 days)

• Evaluate the MTD and DLT of A-319 Treat on Relapsed or Refractory B-cell Lymphoma

  dose limited toxicity(DLT), maximum tolerance dose(MTD)

  At the end of Cycle 1 (each cycle is 28 days)

Secondary Outcomes (7)

• Evaluate the PK(Cmax) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma

  At the end of Cycle3 (each cycle is 28 days)

• Evaluate the PK(AUC) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma

  At the end of Cycle3 (each cycle is 28 days)

• Evaluate the PK(Tmax) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma

  At the end of Cycle3 (each cycle is 28 days)

• Evaluate the PK(T1/2) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma

  At the end of Cycle3 (each cycle is 28 days)

• Evaluate the PK(CL) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma

  At the end of Cycle3 (each cycle is 28 days)

Study Arms (1)

single arm

EXPERIMENTAL

A-319 dosage: 0.05, 0.15, 0.03, 0.06, 0.12, 0.18, 0.24 μg/kg

Biological: Recombinant Anti-CD19m-CD3 Antibody Injection

Interventions

Recombinant Anti-CD19m-CD3 Antibody Injection BIOLOGICAL

Intravenous Infusion

single arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years, all genders
• Patients with definite B-cell Lymphoma, includes FL, MZL, MCL, DLBCL.
• Patients With Relapsed or Refractory B-cell Lymphoma
• ECOG ≤ 2
• Lesions are measurable in 21 days before treatment
• Normal bone marrow function
• Normal liver, kidney, lung and heart function
• the Subjects can sign the ICF and obey the protocol, elsewise, his/her guardian should sign
• Life expectancy is at least 3 months

You may not qualify if:

• Associated with lymphoma by the infiltrates of CNS
• A history of autoimmune disease with CNS involvement or autoimmune disease
• Previous history of autoimmune disease or other malignancy
• A history of deep venous thrombosis or pulmonary embolism
• Auto-HSCT was performed within 12 weeks prior to initiation of treatment
• Previous organ transplantation or allogeneic hematopoietic stem cell transplantation
• The Investigator determined that the patients were associated with a disease, medical condition, or social factor that might affect study results or compliance
• Immunosuppressant are being used
• Radiotherapy was given within 6 weeks prior to A-319 treatment
• Chemotherapy, immunotherapy and targeted therapy were received within 4 weeks before A-319 treatment
• Previous CAR-T cell therapy
• Received anti-lymphoma drugs in the first 4 weeks of A-319 treatment
• There was no recovery of toxic effects (CTCAE\> grade 1 adverse events) at the last treatment, except hair loss
• Those who underwent major surgery 28 days before enrollment (excluding lymph node biopsy);Or plan to operate during the study period
• Those who had received active/attenuated live vaccine within 28 days prior to screening

Sponsors & Collaborators

• EVIVE Biotechnology: lead
• Peking University Cancer Hospital & Institute: collaborator

MeSH Terms

Conditions

Recurrence; Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Song Yuqin, Doctor

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yang Jing, Bachelor

CONTACT

8613524953174; yangj@generonbiomed.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: August 14, 2019
• Study Start: September 15, 2019
• Primary Completion: September 30, 2021
• Study Completion: January 27, 2022
• Last Updated: August 14, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR
• Time Frame: After 20January2022(estimated), for 1years(estimated).
• Access Criteria: All.