Clinical trial · Interventional
CD19-Synthetic T Cell Antigen Receptor(STAR)-T in B-cell Malignancies Patients
CD19-STAR-T for Patients With B Cell Malignancies
NCT03953599CI-TRIAL-00056261completedPhase 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)
This is a single center, single arm, open-lable phase I study to determine the safety and efficacy of CD19-STAR-T cells in patients with refractory and relapsed B-cell malignancies (such as NHL and ALL ).
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 Malignancy | B-Cell Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CD19-STAR-T cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CD19-STAR-T cells
- description
- CD19-STAR-T cells are prepared via lentiviral infection. 5 days prior to infusion of STAR-T cells, subjects receive fludarabine at dose 30mg/m2/day and cyclophosphamide treatment at dose 250mg/m2 for 3 days and take a rest for 2 days before infusion.
- interventionNames
- Biological: CD19-STAR-T cells
Primary outcomes (2)
- measure
- Percentage of adverse events
- timeFrame
- 6 months
- description
- Percentage of participants with adverse events.
- measure
- Objective Remission Rate(ORR)
- timeFrame
- 6 months
- description
- The percentage of participants who achieved complete remission (CR) and partial remission over all participants.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Relapsed and refractory CD19 positive B-cell acute malignancies with: * Relapsed after competed remission, could not get competed remission after at more than 1 course of chemotherapy (including MRD≥0.1%); * MRD≥0.1% after allogeneic hematopoietic stem cell transplantation(HSCT), or recurrence after complete remission or MRD ≥ 0.1% after HSCT; * Refractory: at least two courses of chemotherapy did not achieve complete remission or MRD ≥ 0.1%; 2. Patients must have evaluable evidence of disease, including minimal residual disease (MRD); 3. Ph + patients who meet the following criteria can register:Failure to tolerate TKI or TKI treatment failure, or failure to transplant; 4. Ages 1 to 70 years, including boundary values; 5. ECOG score 0-3 points; 6. Women of childbearing age (15-49 years old) must receive a pregnancy test within 7 days prior to initiation of treatment and the results are negative; male and female patients with fertility must use an effective contraceptive to ensure 3 months after discontinuation of treatment during the study period not pregnant inside. Exclusion Criteria: 1. patients with organ failure: * Heart: NYHA heart function grade III or IV ; * Liver: Grade C that achieves Child-Turcotte liver function grading; * Kidney: kidney failure and uremia; * Lung: symptoms of respiratory failure; * Brain: a person with a disability; 2. Active infections that are difficult to control; 3. Human immunodeficiency virus (HIV) positive; 4. Liver and kidney function: total bilirubin \> 5 × ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \> 5 × ULN, serum creatinine clearance rate 60mL / min; 5. GVHD ≥ 2 or receiving anti-GVHD treatment; 6. Received allogeneic cell therapy within 4 weeks, such as donor lymphocyte infusion(DLI); 7. Subject received anti-tumor treatment (chemotherapy, mAb, or hormone) for less than 1 week; 8. Central nervous system leukemias that is symptomatic or uncontrolled by systemic chemotherapy and intrathecal chemotherapy (a large number of tumor cells in CSF, white blood cell count \>15WBCs/mL); 9. intracranial hypertension or unconsciousness; respiratory failure; diffuse vascular internal coagulation; 10. pregnant or lactating women; 11. The patient does not agree to use effective contraception during the treatment period and for the next 3 months; 12. Patients who participate in other clinical studies at the same time; 13. The investigator believes that there are other factors that are not suitable for inclusion or influence the subject's participation or completion of the study.
References
Publications (0)
Data not yet available
No reference posted for this study.