Clinical trial · Interventional
Adult B-ALL Treated by CART Cell Bridging Allogeneic Hematopoietic Stem Cell Transplantation
A Clinical Trial to Explore the Safety, Efficacy, and Remission Phase of CAR-T Cell in the Treatment of Adult Relapsed Refractory (R/R) Acute Lymphoblastic Leukemia Bridging Allogeneic Hematopoietic Stem Cell Transplantation
- 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 Relapsed Refractory (R/R) adult acute lymphoblastic leukemia bridging allogeneic hematopoietic stem cell transplantation.
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 |
|---|---|---|---|
| Adult B Acute Lymphoblastic Leukemia | Adult B Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CD19 CAR-T | Drug | — | UNRESOLVED |
| CD19+CD22 CAR-T | Drug | — | UNRESOLVED |
| CD22 CAR-T | Drug | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Volunteers
- description
- The patient voluntarily signs the informed consent, and the patient meets the entry criteria to diagnose patients with acute B lymphocytic leukemia expressing specific target antigens
- interventionNames
- Drug: CD19 CAR-T
- Drug: CD22 CAR-T
- Drug: CD19+CD22 CAR-T
- Drug: Fludarabine
- Drug: Cyclophosphamide
Primary outcomes (2)
- measure
- Number of Participants with Severe/Adverse Events as a Measure of Safety
- timeFrame
- 28 days
- description
- Number of Participants with Severe/Adverse Events as a Measure of Safety
- measure
- Copies numbers of CAR in peripheral blood(PB) and/or bone marrow(BM)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
- Maximum age
- 65 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 65 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