Clinical trial · Interventional
Study of CAR-T Cell Therapy in the Treatment of Relapsed/Refractory Hematological Malignancies
Safety and Efficacy Study of Chimeric Antigen Receptor T (CAR-T) Cells in the Treatment of Relapsed/Refractory Hematological Malignancies
NCT05528887CI-TRIAL-00060699unknownPhase 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)
The primary purpose of this study is to determine the safety and efficacy of novel autologous CAR-T cells in patients with relapsed/refractory hematological malignancies.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Myeloma | Multiple Myeloma | ALIAS | 0.90 |
| Relapsed/Refractory Hematological Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous CAR-T cells | Biological | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Autologous CAR-T cells
- description
- A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment, CAR-T cells. CAR-T cells targeted CD19/BCMA/CD123/CD7 are autologous genetically modified T cells.
- interventionNames
- Biological: Autologous CAR-T cells
- Drug: Fludarabine
- Drug: Cyclophosphamide
Primary outcomes (3)
- measure
- TEAEs
- timeFrame
- 4 weeks
- description
- Incidence and severity of Treatment Emergent Adverse Event.
- measure
- TRAEs
- timeFrame
- 4 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histological diagnosis of hematological malignancies (such as lymphoma, myeloma, leukemia) refractory to, or relapsing after standard therapy. 2. Positive expression of specific antigens. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0\~2. 4. Adequate organ functions: * Serum bilirubin ≤ 35 μmol/L; * Serum aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \< 2; * Serum creatinine (Cr) ≤ 2 × upper limit of normal (ULN); * Brain natriuretic peptide (BNP)\<80 pg/mL. 5. Subjects must be able to understand the protocol and be willing to enroll the study, sign the informed consent, and be able to comply with the study and follow-up procedures. Exclusion Criteria: 1. History of allergy to any of the drugs involved in the protocol. 2. History of cardiac diseases: * Left ventricular ejection fraction (LVEF) \< 50%; * Class III or IV heart failure as defined by the New York Heart Association (NYHA). 3. History of another malignancy tumor. 4. Active hepatitis C (HCV), hepatitis B (HBV), human immunodeficiency virus (HIV), or syphilis infection. 5. Patients with any contraindications to allogeneic hematopoietic stem cell transplantation. 6. Uncontrolled fungal, bacterial, viral, or other infection. 7. Female subjects who are pregnant or lactating.
References
Publications (0)
Data not yet available
No reference posted for this study.