Clinical trial · Interventional
Novel CAR-T Cell Therapy in the Treatment of Hematopoietic and Lymphoid Malignancies
Safety and Efficacy Study of Novel CAR-T Cell Therapy in the Treatment of Hematopoietic and Lymphoid Malignancies
NCT05513612CI-TRIAL-00064344withdrawnPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study is not initiated and we want it to be withdrawn.
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 hematopoietic and lymphoid malignancies.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia (AML) | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| B-cell Acute Lymphoblastic Leukemia (B-ALL) | B Acute Lymphoblastic Leukemia | ALIAS | 0.85 |
| B-cell Non-Hodgkin's Lymphoma (B-NHL) | B-Cell Non-Hodgkin Lymphoma | ALIAS | 0.85 |
| Multiple Myeloma (MM) | Multiple Myeloma | CURATED_EXACT | 0.85 |
| T-Cell Leukemia/Lymphoma, Adult | Adult T-Cell Leukemia/Lymphoma | ONTOLOGY_EXACT | 0.98 |
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
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Ability to understand and the willingness to sign informed consent. 2. Patients with relapsed or refractory Acute Myeloid Leukemia (AML), B-cell Non-Hodgkin's Lymphoma (B-NHL), Multiple Myeloma (MM), Adult T-cell Leukemia/Lymphoma (ATL), B-cell Acute Lymphoblastic Leukemia (B-ALL) after at least two cycles of first-line therapy or autologous hematopoietic stem cell transplantation (auto-HSCT). 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0\~2. 4. Adequate organ functions: * Sufficient bone marrow function evaluated by investigator to receive lymphodepleting preparative regimen; * Serum creatinine (Cr) ≤ 1.5 × upper limit of normal (ULN), or creatinine clearance rate (as estimated by Cockcroft Gault) \> 30 mL/min/1.73 m\^2; * Alanine aminotransferase (ALT) ≤ 5×ULN; and total bilirubin (TBIL) \<2.0mg/dL; TBIL of patients with Gilbert's Syndrome or liver involvement must less than 3.0 mg/dL; * Left ventricular ejection fraction (LVEF) \> 40%. 5. Subjects who have previously received CD19 targeted therapy must have biopsy-proven lymphoma lesions still express CD19 antigen. Exclusion Criteria: 1. Lymphomas involving only the central nervous system (CNS) (subjects with secondary CNS lymphomas are admitted). 2. History of another malignancy that has not been in remission for at least 2 year (the following conditions may be excluded from the 2-year restriction: non-melanoma skin cancer, completely resected stage I tumor with low probability of recurrence, limited-stage prostate cancer after treatment, biopsy-proven cervical carcinoma in situ, or PAP smear showing squamous epithelium internal lesions). 3. History of treatment with Alemtuzumab within 6 months prior to leukapheresis, or Fludarabine or Cladribine within 3 months prior to leukapheresis. 4. Active hepatitis C (HCV), hepatitis B (HBV), human immunodeficiency virus (HIV), or syphilis infection. 5. Uncontrolled fungal, bacterial, viral, or other infection. 6. Acute or chronic graft-versus-host disease (GVHD). 7. History of any of the following cardiovascular diseases within the past 6 months: Class III or IV heart failure as defined by the New York Heart Association (NYHA), cardiac angioplasty or stent, myocardial infarction, unstable angina, or other clinically significant heart disease. 8. History or clinical evidence of CNS disease. 9. Female subjects who are pregnant or lactating. 10. Prior CAR-T therapy or other genetically modified T cell therapy.
References
Publications (0)
Data not yet available
No reference posted for this study.