Clinical trial · Interventional
CAR-T Therapy in Relapsed or Refractory Haematopoietic and Lymphoid Malignancies
NCT03121625CI-TRIAL-00027183unknownPhase 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 an open, single-arm, phase I 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 30 patients are planned to be enrolled over a period of 2 years.
Conditions
Conditions (2)
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 | 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
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.The treat history meeting the following criteria: 1. Recurrence of lymphoma patients with imaging (CT/MRI/PET-CT) detection and pathological diagnosis, or recurrence including bone marrow morphology relapse and the MRD recurrence of myeloma patients or leukemia patients, after chemotherapy or stem cell transplantation; 2. Can't get complete remission (including MRD positive) after more than twice repeated chemotherapy of incipient lymphoma, myeloma or leukemia patients; 3. One or twice chemotherapy cannot get remission again (including MRD positive), but not suitable for chemotherapy of incipient lymphoma, myeloma or leukemia patients. 2\. There is a measurable lesions before treatment at least; 3. ECOG score≤2; 4. To be aged 1 to 70 years; 5. 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 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. Happened in 3 \~ 4 acute GvHD after allogeneic hematopoietic stem cell transplantation on recurring patients 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.