Clinical trial · Interventional
Combination CAR-T Cell Therapy Targeting Hematological Malignancies
Combination CAR-T Therapy of 4SCAR19 Plus 4SCAR20, 22, 38, 70 and 123 Targeting Hematological Malignancies
- 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 study will evaluate safety and efficacy of a combination of 4th generation chimeric antigen receptor gene-modified T cells targeting CD19 (4SCAR19) and CD20 (4SCAR20), CD22 (4SCAR22), CD30 (4SCAR30), CD38 (4SCAR38), CD70 (4SCAR70) or CD123 (4SCAR123) for patients with B cell malignancies. Clinical response and development of a standardized lentiviral vector and cell production protocol will be investigated. This is a phase I/II trial enrolling patients from multiple clinical centers.
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 (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 4SCAR19 and 4SCAR123 | Biological | — | UNRESOLVED |
| 4SCAR19 and 4SCAR20 | Biological | — | UNRESOLVED |
| 4SCAR19 and 4SCAR22 | Biological | — | UNRESOLVED |
| 4SCAR19 and 4SCAR30 | Biological | — | UNRESOLVED |
| 4SCAR19 and 4SCAR38 | Biological | — | UNRESOLVED |
| 4SCAR19 and 4SCAR70 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 4SCAR19 and 4SCAR20/CD22/CD30/CD38/CD70/CD123
- description
- Patients who have relapsed and refractory B cell malignancies after chemotherapy will be treated with CD19 and CD20/CD22/CD30/CD38/CD70/CD123-specific gene-engineered T cells.
- interventionNames
- Biological: 4SCAR19 and 4SCAR22
- Biological: 4SCAR19 and 4SCAR38
- Biological: 4SCAR19 and 4SCAR20
- Biological: 4SCAR19 and 4SCAR123
- Biological: 4SCAR19 and 4SCAR70
- Biological: 4SCAR19 and 4SCAR30
Primary outcomes (1)
- measure
- Safety of fourth generation anti CD19 and CD20/CD22/CD30/CD38/CD70/CD123 CAR-T cells in patients with relapsed B cell malignancies using CTCAE 4 standard to evaluate the level of adverse events standard to evaluate the level of adverse events
- timeFrame
- 24 weeks
- description
- physiological parameter (for safety, measuring cytokine response, fever, symptoms)
Secondary outcomes (1)
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/CD20/CD22/CD30/CD38/CD70/CD123 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, the treatment is difficult to assess patient response. 2. bacteria, fungus, or virus infection, unable to control. 3. living with HIV. 4. active HBV and HCV infection. 5. pregnant and nursing mothers. 6. under systemic steroid treatment within a week of the treatment. 7. prior failed CAR-T treatment.
References
Publications (1)
- DERIVEDNair S, Wang JB, Tsao ST, Liu Y, Zhu W, Slayton WB, Moreb JS, Dong L, Chang LJ. Functional Improvement of Chimeric Antigen Receptor Through Intrinsic Interleukin-15Ralpha Signaling. Curr Gene Ther. 2019;19(1):40-53. doi: 10.2174/1566523218666181116093857. PMID 30444200