Clinical trial · Interventional
CD19-CAR-T Cells in Patients With R/R B-ALL
Phase I Study of the Safety and Efficacy of CD19-CAR-T Cells in Patients With Relapsed or Refractory Acute B-cell Lymphoblastic Leukemia (R/R B-ALL)
NCT03574168CI-TRIAL-00033524unknownPhase 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 a single center, single arm, open-lable phase 1 study to determine the safety and efficacy of autologous or donor-derived allogeneic T cells expressing CD19 chimeric antigen receptors (referred to as "CD19-CAR-T cells") in patients with relapsed or refractory acute B-cell lymphoblastic leukemia (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-cell Acute Lymphoblastic Leukemia | B Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CD19-CAR-T Cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CD19-CAR-T Cells
- description
- Subjects will receive CD19-CAR-T Cells on Day 0 : 100% of total dose.
- interventionNames
- Biological: CD19-CAR-T Cells
Primary outcomes (1)
- measure
- Objective Response Rate, ORR
- timeFrame
- Up to Day90 after the CD19-CAR-T cell infusion
- description
- The percentage of participants who achieved complete remission (CR) over all participants (CRR). The percentage of participants who achieved partial remission (PR) over all participants (PRR).
Secondary outcomes (2)
- measure
- The amount of CAR-T cells remaining in vivo
- timeFrame
- 2 years after cell infusion.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Obtain Informed Consent Form (ICF) voluntarily signed by the patient; 2. Age 3-70 years old; 3. Primary resistant or relapsed B-cell line acute lymphoblastic leukemia; 4. B cells are positive for CD19 expression; 5. Peripheral blood tumor cell load \<50%; 6. KPS score \>50 points; 7\. Normal liver and kidney function; 8. Normal heart function; 9. Good follow-up compliance; 10. Women of childbearing age (15-49 years old) must have a pregnancy test within 7 days before treatment and have a negative result; Men and women with fertility should agree to use effective contraception to ensure that during the study period and following 3 months after treatment the women will not get pregnant. Exclusion Criteria: 1. Patients with non-B cell acute leukemia; 2. Organ failure: Heart: Grade III and IV Liver: Class C with Child-Turcotte liver function classification Kidney: Renal failure and uremia Lung: severe respiratory failure Brain: Disabilities 3. Active infection; 4. Human immunodeficiency virus (HIV) positive; 5. Acute and chronic graft-versus-host disease (GVHD)\> Level 1； 6. Pregnant or lactating women; 7. Patients do not agree to use effective contraception during the treatment period and following 3 months; 8. Patients who participated in other clinical studies at the same time; 9. The researcher believes that there are other factors that are not suitable for inclusion in or influence the subject's participation in or completion of the study; 10. Long-term use greater doses of hormones than physiological doses.
References
Publications (0)
Data not yet available
No reference posted for this study.