Status:
UNKNOWN
Study of A-319 in Patients With Relapsed or Refractory B-cell Lymphoma
Lead Sponsor:
EVIVE Biotechnology
Collaborating Sponsors:
Peking University Cancer Hospital & Institute
Conditions:
Relapsed or Refractory B-cell Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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
Detailed 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
Eligibility Criteria
Inclusion
- 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
- • 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
Key Trial Info
Start Date :
September 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 27 2022
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT04056975
Start Date
September 15 2019
End Date
January 27 2022
Last Update
August 14 2019
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