Clinical trial NCT04056975: Study of A-319 in Patients With Relapsed or Refractory B-cell Lymphoma
Official title: A Phase I, Single Centre, Open-label, Dose-escalation Study of A-319 in Patients With Relapsed or Refractory B-cell Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Relapsed or Refractory B-cell Lymphoma
Lead sponsor: EVIVE Biotechnology
Sponsor class: INDUSTRY
Collaborators: name: Peking University Cancer Hospital & Institute
First posted: 2019-08-14
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Evaluate the Incidence and Characteristics of SAE of A-319 Treat on Relapsed or Refractory B-cell Lymphoma
timeFrame: At the end of Cycle 1 (each cycle is 28 days)
measure: Evaluate the MTD and DLT of A-319 Treat on Relapsed or Refractory B-cell Lymphoma
timeFrame: At the end of Cycle 1 (each cycle is 28 days)
Secondary outcomes:
measure: Evaluate the PK(Cmax) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma
timeFrame: At the end of Cycle3 (each cycle is 28 days)
measure: Evaluate the PK(AUC) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma
timeFrame: At the end of Cycle3 (each cycle is 28 days)
measure: Evaluate the PK(Tmax) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma
timeFrame: At the end of Cycle3 (each cycle is 28 days)
measure: Evaluate the PK(T1/2) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma
timeFrame: At the end of Cycle3 (each cycle is 28 days)
measure: Evaluate the PK(CL) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma
timeFrame: At the end of Cycle3 (each cycle is 28 days)
measure: Evaluate the PK(Vz) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma
timeFrame: At the end of Cycle3 (each cycle is 28 days)
measure: Evaluate the PD of A-319 Treat on Relapsed or Refractory B-cell Lymphoma
timeFrame: At the end of Cycle3 (each cycle is 28 days)
Other outcomes:
Locations:
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Song Yuqin, Doctor
role: PRINCIPAL_INVESTIGATOR
References: