Clinical trial · Interventional
Study of A-319 in Patients With Relapsed or Refractory B-cell Lymphoma
A Phase I, Single Centre, Open-label, Dose-escalation Study of A-319 in Patients With Relapsed or Refractory B-cell Lymphoma
NCT04056975CI-TRIAL-00040050A-319unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Title: A Phase I, Single Centre, Open-label, Dose-escalation Study of A-319 in Patients With Relapsed or Refractory B-cell Lymphoma
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed or Refractory B-cell Lymphoma | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Recombinant Anti-CD19m-CD3 Antibody Injection | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- single arm
- description
- A-319 dosage: 0.05, 0.15, 0.03, 0.06, 0.12, 0.18, 0.24 μg/kg
- interventionNames
- Biological: Recombinant Anti-CD19m-CD3 Antibody Injection
Primary outcomes (2)
- 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)
- description
- Incidence and Characteristics of SAE
- 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)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.