Clinical trial · Interventional
Sequential Treatment With CD20/CD22/CD10-CART After CD19-CART Treatment Base on MRD in Relapsed/Refractory B-ALL
NCT03407859CI-TRIAL-00075031unknownEarly Phase 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)
CD19-negative B-ALL relapses after CD19 CAR T-cell treatment have occurred in some patients. CD20/CD22/CD10 is still expressed in CD19 negative B-ALL cells which means these CD molecules may become new targets in treatment of CD19-negative relapse of B-ALL. Thus sequential treatment with CD20/CD22/CD10-CART after CD19-CART treatment in relapsed/refractory B-ALL will kill and eliminate CD19 negative B-ALL cells and prolong the remission time.
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 |
|---|---|---|---|
| Therapy Related Leukemia | Therapy-Related Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sequential Treatment With different CART | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sequential therapy with different CART
- description
- Sequential therapy With different CART including one kind of CD20/CD22/CD10-CART After CD19-CART therapy in CD19-negative relapse ALL patients, subjects will receive 1-5 x 10\^6/Kg transduced CAR T cells at one time.
- interventionNames
- Biological: Sequential Treatment With different CART
Primary outcomes (1)
- measure
- Adverse events that Are related to treatment
- timeFrame
- 2 years
- description
- Determine the toxicity profile of the CD19-targeted and CD20/CD22/CD10-targeted CAR-T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
Secondary outcomes (3)
- measure
- Estimate 2 year overall survival(OS) after infusion of CD19-CART and sequential treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: 1. Relapsed/Refractory B-ALL patients 2. Did not achieve complete remission after 2 times of standard plan chemotherapy 3. Relapsed after first induction chemotherapy 4. Did not response to chemotherapy before HSCT or relapsed after HSCT 5. Cannot receive allo-HSCT or refuse to receive allo-HSCT 6. Cell phenotype is CD19 and CD20/CD22/CD10/CD70 positive (single or combined) 7. Estimated survival time is more than 3 months in leukemia 8. Volunteered for this clinical trail and signed a consent form Exclusion Criteria: 1. MRD was negative while the cell phenotype was CD19 expressed 2. Patients with severe insufficient cardiac, pulmonary and hepatorenal functions 3. Patients with severe mental illness, neurological disease or infectious disease 4. Patients with GVHD was taking immunosuppressants 5. Pregnant or lactating women 6. Patients have received other genetic therapy products 7. Transfection efficiency was less than 30% 8. Any situation may do harm to the subjects or interfere the results
References
Publications (0)
Data not yet available
No reference posted for this study.