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

Relapsed or Refractory B-cell Lymphoma Clinical Trial

— A-319  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04056975
• Other study ID #: SP071744
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: September 15, 2019
• Est. completion date: January 27, 2022

Study information

• Verified date: August 2019
• Source: Generon (Shanghai) Corporation Ltd.
• Contact: Yang Jing, Bachelor
• Phone: 8613524953174
• Email: yangj[@]generonbiomed.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Protocol Number: SP071744 Study Stage: Phase I Study Number: 1 site Subject Number: up to 54 patients with Relapsed or Refractory B-cell Lymphoma

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 54
• Est. completion date: January 27, 2022
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 18-75 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

Exclusion Criteria:• Past or present CNS disease

• 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

• For pregnant (positive pregnancy test) and lactating women, those of childbearing age who signed the informed consent form and did not agree to use contraception for at least 3 months after the end of the study;Within 7 days prior to the first day of treatment, women of childbearing age require a positive serum pregnancy test (HCG)

• Male patients who signed informed consent forms and did not agree to use contraception for at least 3 months at the end of the study (except surgical sterilization)

• Known allergy to immunoglobulin or research drugs and their excipients

• Patients considered unfit to participate in the study

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Relapsed or Refractory B-cell Lymphoma

Intervention

Biological:
• Recombinant Anti-CD19m-CD3 Antibody Injection
Intravenous Infusion

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Generon (Shanghai) Corporation Ltd.	Beijing Cancer Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Evaluate the PK(Cmax) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma	Peak Plasma Concentration(Cmax)	At the end of Cycle3 (each cycle is 28 days)
Secondary	Evaluate the PK(AUC) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma	Area under the plasma concentration versus time curve(AUC)	At the end of Cycle3 (each cycle is 28 days)
Secondary	Evaluate the PK(Tmax) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma	time to peak (Tmax)	At the end of Cycle3 (each cycle is 28 days)
Secondary	Evaluate the PK(T1/2) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma	half-life time(T1/2)	At the end of Cycle3 (each cycle is 28 days)
Secondary	Evaluate the PK(CL) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma	clearance(CL)	At the end of Cycle3 (each cycle is 28 days)
Secondary	Evaluate the PK(Vz) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma	volume of distribution(Vz)	At the end of Cycle3 (each cycle is 28 days)
Secondary	Evaluate the PD of A-319 Treat on Relapsed or Refractory B-cell Lymphoma	B-cell level	At the end of Cycle3 (each cycle is 28 days)