Clinical trial · Interventional
Immunotherapy With Bispecific CAR-T Cells for B-Cell Lymphoma, ALL and CLL
Phase I Study of T Cells Expressing an Anti-CD19 and Anti-CD20 Bispecific Chimeric Receptor in Patients With B Cell Malignancies
NCT03271515CI-TRIAL-00049514unknownPhase 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)
This study aims to evaluate the safety, efficacy and duration of response of anti-CD19 anti-CD20 Bispecific Chimeric Antigen Receptor (CAR) redirected autologous T-cells in patients with high risk, relapsed CD19+ and CD20+ haematological malignancies.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| anti-CD19 anti-CD20 Bispecific CAR-T | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- conventional therapy
- description
- patients accept conventional radioactive and chemical therapy.
- type
- EXPERIMENTAL
- label
- anti-CD19 anti-CD20 Bispecific CAR-T
- description
- patients accept transfusion of anti-CD19 anti-CD20 Bispecific CAR-T cells.
- interventionNames
- Biological: anti-CD19 anti-CD20 Bispecific CAR-T
Primary outcomes (1)
- measure
- Antitumor Effects
- timeFrame
- Every 3 months post treatment up to 24 months
- description
- Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Relapsed or refractory B cell derived acute lymphoblastic leukemia(ALL), chronic lymphoblastic leukemia(CLL) and non-hodgkin lymphoma. 2. KPS\>60. 3. Life expectancy\>3 months. 4. Gender unlimited, age from 18 years to 70 years. 5. CD19 or CD20 expression must be detected on greater than 15% of the malignant cells by immunohistochemistry or greater than 30% by flow cytometry. 6. Patients who have failed at least one line of a standard treatment. 7. No serious mental disorder. 8. Patients must have adequate cardiac function(no cardiac disease, LVEF≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of \>94%, and adequate renal function(Cr≤133umol/L). 9. No other serious diseases(autoimmune disease, immunodeficiency etc.). 10. No other tumors. 11. Patients volunteer to participate in the research. 12. Patients with history of allogeneic stem cell transplantation are eligible if at least 100 days post-transplant, if there is no evidence of active GVHD and no longer taking immunosuppressive agents for at least 30 days prior to trial. Exclusion Criteria: 1. KPS\<50. 2. Patients are allergic to cytokines. 3. Central nervous system leukemia within 28 days. 4. Uncontrolled active infection. 5. Acute or chronic GVHD. 6. Treated with T cell inhibitor. 7. Pregnancy and nursing females. 8. HIV/HBV/HCV Infection. 9. Other situations we think improper for the research.
References
Publications (0)
Data not yet available
No reference posted for this study.