Clinical trial · Interventional
Anti-CD22 CAR-T Cell Therapy Targeting B Cell Malignancies
Anti-CD22 Chimeric Antigen Receptor (CAR)-Modified T Cell Therapy Targeting CD22 in Treating Patients With B Cell Malignancies
NCT03262298CI-TRIAL-00049943unknownPhase 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 study will evaluate safety and efficacy of the CD22-targeted chimeric antigen receptor modified-T cell(CAR-T) cells in the treatment of B-cell 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-CD22-CAR-transduced T cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- anti-CD22 CAR-T
- description
- Patients will receive a full dose CART infusion at day 0.
- interventionNames
- Biological: Anti-CD22-CAR-transduced T cells
Primary outcomes (1)
- measure
- Incidence of adverse events related to treatment as assessed by NCI CTCAE version 4.03
- timeFrame
- 2 years
Secondary outcomes (3)
- measure
- Overall Complete Remission Rate (ORR)
- timeFrame
- 2 years
- measure
- Disease response(CR, CRi)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age: 18-65 years 2. Patients with Cluster of Differentiation 22(CD22) positive B cell malignancies as confirmed by flow cytometry 3. Refractory or relapsed B cell-acute lymphoblastic leukemia 4. No available curative treatment options (such as hematopoietic stem cell transplantation) 5. Stage III-IV disease 6. Creatinine \< 2.5 mg/dl 7. Aspartate transaminase-alanine transaminase ratio \< 3x normal 8. Bilirubin \< 2.0 mg/dl 9. Karnofsky performance status \>= 60 10. Expected survival time \> 3 months 11. Adequate venous access for apheresis 12. Ability to understand and provide informed consent Exclusion Criteria: 1. Pregnant or lactating women 2. Patients requiring T cell immunosuppressive therapy 3. Active central nervous system leukemia 4. Any concurrent active malignancies 5. Patients with a history of a seizure disorder or cardiac disorder 6. Previous treatment with any immunotherapy products 7. Patients with human immunodeficiency virus, hepatitis B or C infection 8. Uncontrolled active infection
References
Publications (0)
Data not yet available
No reference posted for this study.