Clinical trial · Interventional
CD19/22 Bi-specific CAR-T Cell Therapy
CD19/22 Bi-specific CAR-T Cells Targeting B Cell Malignancies
NCT05432882CI-TRIAL-00123827not yet 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 purpose of this study is to assess the feasibility, safety and efficacy of anti-CD19/22 bi-specific CAR-T cell therapy in patients with CD19 and/or CD22 positive B cell malignancies. Another goal of the study is to learn more about the safety and function of the anti-CD19/22 bi-specific CAR-T cells and their persistency in patients.
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 Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bi-4SCAR CD19/22 T cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- bi-4SCAR-CD19/22 T Cell Therapy for CD19 and/or CD22 positive B cell malignancies
- interventionNames
- Biological: bi-4SCAR CD19/22 T cells
Primary outcomes (1)
- measure
- Safety of fourth generation bi-4SCARCD19/22 T cells in patients with B cell malignancies
- timeFrame
- 24 weeks
- description
- Safety of fourth generation bi-4SCARCD19/22 T cells in patients with B cell malignancies using CTCAE 4 standard to evaluate the level of adverse events standard to evaluate the level of adverse events
Secondary outcomes (1)
- measure
- Anti tumor activity of fourth generation bi-4SCARCD19/22 T cells in patients with relapsed or refractory B cell malignancies
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Months
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. age older than 6 months. 2. malignant B cell surface expression of CD19 or CD22 molecules. 3. the KPS score over 80 points, and survival time is more than 1 month. 4. greater than Hgb 80 g/L.5. no contraindications to blood cell collection. Exclusion Criteria: 1. accompanied with other active diseases and difficult to assess patient response. 2. bacterial, fungal, or viral infection, unable to control. 3. living with HIV.4. active HBV or HCV infection. 5\. pregnant and nursing mothers. 6. under systemic steroid treatment within a week of the treatment. 7. prior failed CD19 and CD22 CAR-T treatment.
References
Publications (0)
Data not yet available
No reference posted for this study.