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

Evive Biotech

Status and phase

Unknown

Phase 1

Conditions

Relapsed or Refractory B-cell Lymphoma

Treatments

Biological: Recombinant Anti-CD19m-CD3 Antibody Injection

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04056975

SP071744

Details and patient eligibility

About

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

Full 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

Enrollment

54 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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