Clinical trial · Interventional
A Prospective Clinical Study of CD3-CD20 Bisspecific Antibody Based Therapy Combined With CD19-CAR T Cells in the Treatment of Relapsed Refractory B-cell Non-Hodgkin Lymphoma
NCT06464185CI-TRIAL-00116760active not recruitingPhase 1 / Phase 2ClinicalTrials.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)
The aim of this study was to analyze the safety and efficacy of CD3-CD20 bispecific antibody-based therapy in combination with CD19-CAR-T cells for the treatment of relapsed and refractory B-cell Non-Hodgkin's (B-NHL) lymphoma. The main questions it aims to answer: 1. The safety of CD3-CD20 bispecific antibody-based therapy in combination with CD19-CAR-T cells in B-NHL; 2. The effect of different doses of bispecific antibody maintenance therapy on CAR-T cell expansion.
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 |
|---|---|---|---|
| B-cell Non-Hodgkin Lymphoma | B-Cell Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bispecific antibody-based combined with CAR-T cell therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bispecific antibody-based therapy combined with CAR-T cell therapy
- interventionNames
- Drug: Bispecific antibody-based combined with CAR-T cell therapy
Primary outcomes (1)
- measure
- Incidence rate and severity of adverse events (AE) of patients treated with bispecific antibody combined with CD19-CAR-T cells in B-NHL.(Assessed by CTCAE criteria v5 and ASTCT 2019 criteria for CRS/ICANS adverse events.)
- timeFrame
- Up to 30 days after last treatment.From registration and during the bridging treatment, until end of post-treatment safety reporting window (up to six months after last dose of glofitamab)
- description
- Assess the safety and toxicity of CD3-CD20 bispecific antibody-based therapy in combination with CD19-CAR-T cells in B-NHL. Assessed in all patients given at least one dose of study treatment and infused.
Secondary outcomes (2)
- measure
- Complete Response (CR) Rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * The patient has fully understood the study and voluntarily signed the informed consent form (ICF) * Must meet the diagnostic criteria for relapsed and refractory B-NHL and have evaluable disease lesions, in addition to the following characteristics for different types of B-NHL: A, Diffuse large B-cell Lymphoma: Patients with histologically confirmed DLBCL; Patients who must have received ,anthracyclines CD20 monoclonal antibodies and BTK inhibitors and other Drug therapy, and have received at least two lines of treatment and relapsed, not relieved or progressed within 24 months after the last line of treatment; B, Relapsed and Refractory Follicular lymphoma (FL): Tissue Biopsy proved FL: grade 1-3a; Must have received anthracyclines and CD20 monoclonal antibody Drug therapy, and have received at least two lines of treatment and relapsed, not remitted or progressed within 24 months after the last line of treatment; C, Relapsed and Refractory Marginal zone lymphoma (MZL): Histologically unequivocally confirmed MZL; Must have received anthracyclines and CD20 monoclonal antibody Drug therapy, and have received at least two lines of treatment and relapsed, not remitted or progressed within 24 months after the last line of treatment; D, Relapsed and refractory Mantle cell lymphoma (MCL): Histologically confirmed MCL; Relapsed or refractory after at least 2 lines of therapy (including anti-CD20 monoclonal antibody, anthracyclines or bendamustine, and BTKi); E, Relapsed and refractory CLL: Histologically confirmed CLL; Patients who have received at least Immunochemotherapy and have Drug therapy to both BTK inhibitors and BCL2 inhibitors Drug resistance; F, Relapsed and refractory WM: Patients with histologically confirmed WM; Patients who must have received anthracyclines, CD20 monoclonal antibodies and BTK inhibitors and other Drug therapy, and have received at least two lines of treatment and relapsed, not relieved or progressed within 24 months after the last line of treatment; * ECOG score 0-1 * Laboratory test: Neutrophils 0.5 x 10 \^ 9/L; platelets 30 x 10 \^ 9/L; Bilirubin total 2 x upper limit; GPT/Glutamic-oxaloacetic transferase 3 x upper limit. Creatinine clearance ≥ 30 mL/min. * The expected survival time of patients is ≥ 6 months; Exclusion Criteria: * Neoplasm malignant other than B-NHL (except active central nervous system lymphoma) diagnosed or treated within the past year; Patients who received anti Neoplasm therapy (including chemotherapy, targeted therapy, hormone therapy, traditional Chinese medicine with anti neoplasm activity, etc.) or participated in other clinical trials and received the investigational drug within 4 weeks before the first use of the investigational drug; * Liver renal impairment not related to lymphoma: GPT (ALT) \> 3 times the upper limit of normal, glutamic-oxaloacetic transferase (AST) \> 3 times the upper limit of normal, bilirubin total (TBIL) \> 2 times the upper limit of normal, serum creatinine clearance rate \< 30ml/min; * Other serious medical diseases that will affect the study (such as uncontrolled Diabetes mellitus, gastric ulcer, other serious heart lung disease, etc.), and the right to decide belongs to the investigator. * Cardiac function and disease meet one of the following conditions: A, Long QTc syndrome or QTc interval \> 480 MS; B, Complete left bundle branch block, grade II or III AV block; C, Serious, uncontrolled arrhythmia requiring drug therapy; D, New York Heart Association Heart disorder grade ≥ III; E, Cardiac Ejection Fraction (LVEF) less than 50%; F, Ischaemia, unstable Angina pectoris, history of severe unstable Ventricular arrhythmia or any other Arrhythmia requiring treatment, history of clinically significant Pericardial disease, or Electrocardiogram evidence of acute Myocardial infarction or active conduction system abnormalities within 6 months prior to recruitment; * Known history of Infection human Immunodeficiency virus (HIV) or active Hepatitis B virus (HBV) Infection, or any uncontrolled active Injection requiring intravenous Systemic infection of antibiotics; Patients in the past 14 days received a large surgery (excluding lymph node Biopsy) or expected treatment in the need for a large Surgery; * Previous or current other neoplasm malignant (except effectively controlled skin Basal cell carcinoma without melanoma, breast/In situ cancer of cervix, and other effectively controlled Neoplasm malignant without treatment within the past five years * Pregnancy or lactating women, women of childbearing age who did not take contraception measures; * Hypersensitivity to the drugs or ingredients used;
References
Publications (0)
Data not yet available
No reference posted for this study.