Clinical trial · Interventional
Senl-h19 CAR-T Cell Injection in the Treatment of Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia
NCT04792593CI-TRIAL-00050612unknownN/AClinicalTrials.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 study is an open, dose-escalating clinical study, taking patients with relapsed or refractory acute lymphoblastic leukemia as the test subjects, including mouse-derived CAR-T treatment failure or relapse, or for any reason cannot bridge the transplant r/r B-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-ALL | B Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Senl-h19 CAR-T | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Senl-h19 CAR-T
- description
- Patients will be treated with Senl-h19 CAR-T cells
- interventionNames
- Biological: Senl-h19 CAR-T
Primary outcomes (2)
- measure
- Safety: Incidence and severity of adverse events
- timeFrame
- First 1 month post CAR-T cells infusion
- description
- To evaluate the possible adverse events occurred within first one month after CD7 CAR-T infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity
- measure
- Efficacy: Remission Rate
- timeFrame
- 3 months post CAR-T cells infusion
- description
- Remission Rate including complete remission(CR)、CR with incomplete blood count recovery(CRi)、No remission(NR)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 1\. Sign the informed consent and be willing and able to comply with the visit, treatment protocol, laboratory examination, and other requirements of the study as specified in the study procedure sheet; 2. A definite diagnosis of relapsed and refractory acute B-lymphoblastic leukemia meets one of the following criteria: a) Mouse CAR-T treatment fails or relapses; B) Unable to bridge the graft for any reason; 3. Eastern Cooperative Oncology Group (ECOG) score ≤2; 4. Age ≥2 years old, male or female 5. CD19 positive tumor cells were detected by immunohistochemistry or flow cytometry; 6. Expected survival longer than 3 months; 7. The collection time of peripheral blood mononuclear immune cells must be at least 2 weeks from the last radiotherapy or systematic treatment of patients; Exclusion Criteria: * 1\. Severe cardiac insufficiency; 2. Have a history of severe lung impairment; 3. Complicated with other advanced malignant tumors; 4. Complicated with severe or persistent infection that cannot be effectively controlled; 5. Complicated with severe autoimmune diseases or congenital immune deficiency; 6. Active hepatitis (HBVDNA or HCVRNA positive); Human immunodeficiency virus (HIV) infection or syphilis infection; 8. Have a history of severe allergy to biological products (including antibiotics); 9. The female patient is pregnant and lactating, or has a pregnancy plan within 12 months; 10. Conditions that the investigator believes may increase the risk to the subject or interfere with the outcome of the study.
References
Publications (0)
Data not yet available
No reference posted for this study.