Clinical trial · Interventional
A Study of Universal CD19-Targeted UCAR-NK Cells Combined With HSCT for B Cell Hematologic Malignancies
An Investigator-initiated Trial Evaluating the Efficacy and Safety of Anti-CD19 Universal CAR-NK(UCAR-NK) Cells Therapy Combined With Hematopoietic Stem Cell Transplantation(HSCT) for B Cell Hematologic Malignancies
NCT05654038CI-TRIAL-00062800unknownPhase 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)
It is a single-center, open-labeled, single-arm, non-randomized investigator-initiated trial evaluating the efficacy and safety of anti-CD19 universal CAR-NK(UCAR-NK) cells therapy combined with HSCT for B cell hematologic malignancies.
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 Lymphoblastic Leukemia/Lymphoma | B Lymphoblastic Leukemia/Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anti-CD19 UCAR-NK cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Target CD19 UCAR-NK cells
- description
- Subjects who meet the enrollment conditions will receive intravenous infusion of anti-CD19 UCAR-NK Cells within 1 week after hematopoietic stem cell infusion.
- interventionNames
- Biological: Anti-CD19 UCAR-NK cells
Primary outcomes (1)
- measure
- Incidence of adverse events(AE) after infusion
- timeFrame
- Up to 12 months after infusion
- description
- The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included. Description, time, classification, and outcome of AE events resulted from the investigational medical product, delivery method, or emergency measures will be recorded in the case report form.
Secondary outcomes (7)
- measure
- Granulocyte implantation time
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with indications for hematopoietic stem cell transplantation; 2. Age ≤75 years old; 3. Confirmed B-cell tumor and tumor cells expressing CD19; 4. Expected survival time \>12 weeks; 5. Eastern cooperative oncology group (ECOG) score is 0-2; 6. Adequate liver , kidney and cardiopulmonary function; 7. Willingness to complete the informed consent process and to comply with study procedures and visit schedule. Exclusion Criteria: 1. Had received NK cell therapy or other genetically modified cell therapy within 1 year before screening; 2. At least 14 days or at least 5 half-lives of antitumor therapy had elapsed before screening; 3. Patients who had undergone hematopoietic stem cell transplantation (ASCT), allogeneic hematopoietic stem cell transplantation (HSCT), or solid organ transplantation within 12 weeks before screening; Grade 2 or higher graft versus host disease(GVHD) requiring immunosuppressive therapy occurred within 2 weeks before screening; 4. Patients with atrial or ventricular lymphoma or need urgent treatment due to tumor mass such as intestinal obstruction or vascular compression; 5. Have received live attenuated vaccine within 6 weeks before rinsing; 6. Had a cerebrovascular accident or seizure within 6 months before screening; 7. History of deep venous thrombosis or pulmonary embolism within 6 months before screening; 8. A history of myocardial infarction, bypass or stent bypass, unstable angina, or other clinically significant heart disease within 12 months prior to screening; 9. Previous history of Alzheimer's disease; 10. Autoimmune diseases leading to end-organ damage or requiring systemic immunosuppression (e.g. Crohns, rheumatoid arthritis, systemic lupus erythematosus) within 2 years prior to screening; 11. There are uncontrollable infections; 12. Women who are pregnant or breastfeeding; Or women of childbearing age who have positive pregnancy tests during the screening period; Male or female patients who did not wish to use contraception from the time of signing the informed consent to 1 year after receiving the NK cell infusion; 13. Conditions that other researchers deemed inappropriate for participating in the study.
References
Publications (0)
Data not yet available
No reference posted for this study.