Clinical trial · Interventional
CAR-T Cells for Relapsed or Refractory Haematopoietic and Lymphoid Malignancies
NCT03312205CI-TRIAL-00036439unknownPhase 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)
This is an open, single-arm, phase I/phase II clinical study to evaluate efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) in the treatment of hematopoietic and lymphoid malignancies. A total of 50 patients are planned to be enrolled over a period of 2 years.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous CAR-T cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Autologous CAR-T cells
- description
- Patients will be be treated with autologous CAR-T cells
- interventionNames
- Biological: Autologous CAR-T cells
Primary outcomes (1)
- measure
- Tumor load
- timeFrame
- Up to 24 months
- description
- Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis.
Secondary outcomes (1)
- measure
- CAR-T cell persistence
- timeFrame
- Up to 24 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Be diagnosed a kind of Relapsed or Refractory Haematopoietic and Lymphoid Malignancies: 2. ECOG score≤2; 3. To be aged 1 to 70 years; 4. More than a month lifetime from the consent signing date. Exclusion Criteria: 1. Serious cardiac insufficiency, left ventricular ejection fraction\<50%; 2. Has a history of severe pulmonary function damaging; 3. Merging other progressing malignant tumor; 4. Merging uncontrolled infection; 5. Merging the metabolic diseases (except diabetes); 6. Merging severe autoimmune diseases or immunodeficiency disease; 7. Patients with active hepatitis B or hepatitis C; 8. Patients with HIV infection; 9. Has a history of serious allergies on Biological products (including antibiotics); 10. Has acute GvHD on allogeneic hematopoietic stem cell transplantation patients after stopping immunosuppressants a month; 11. Pregnancy or lactation women; 12. Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.
References
Publications (0)
Data not yet available
No reference posted for this study.