Clinical trial · Interventional
CART19 in Adult Patients With Minimal Residual Disease During Upfront Treatment for ALL
Phase 2 Study of CD19-directed Chimeric Antigen Receptor-modified T Cells (CART19) for Adult Patients With Minimal Residual Disease During Upfront Treatment for Acute Lymphoblastic Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study is terminated because of administrative reasons.
Summary
Brief summary (as posted)
This is a single center, single arm, open-label phase 2 study to determine the efficacy of autologous T cells expressing CD19 chimeric antigen receptors expressing tandem TCRζ and 4-1BB (TCRζ/4-1BB) co-stimulatory domains (referred to as "CART19" cells) in adults with minimal residual disease (MRD) during upfront treatment for CD19+ acute lymphoblastic leukemia.
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 |
|---|---|---|---|
| Leukemia, Acute Lymphoblastic | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CART 19 | Biological | Tisagenlecleucel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CART19
- description
- CART19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRz:41BB administered by IV infusion.
- interventionNames
- Biological: CART 19
Primary outcomes (1)
- measure
- The Incidence of Conversion of Minimal Residual Disease (MRD) to <0.01%
- timeFrame
- Day 28
- description
- The incidence of conversion of minimal residual disease (MRD) to \<0.01% after CART19 therapy in patients with MRD+ ALL during upfront treatment
Secondary outcomes (6)
- measure
- Best Overall Survival (OS)
- timeFrame
- one year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with CD19+, B cell Acute Lymphoblastic Leukemia (B-ALL) who have 0.01%≤MRD\<10% during upfront treatment 2. Patients must be within 18 months of initial ALL diagnosis 3. Age ≥18 years 4. Adequate organ function defined as: 1. Creatinine ≤ grade 2 2. ALT/AST ≤3x upper limit of normal range for age 3. Direct bilirubin ≤2.0 mg/dl 4. Adequate pulmonary function defined as ≤ grade 2 dyspnea and ≤ grade 2 hypoxia 5. Cardiac Left Ventricle Ejection Fraction (LVEF) ≥ 40% confirmed by ECHO/MUGA 5. Patients with CNS3 disease will be eligible if CNS disease is responsive to therapy. 6. Expression of CD19 on leukemic blasts demonstrated by flow cytometry or immunohistochemistry of bone marrow or peripheral blood 7. Adequate performance status defined as ECOG Performance Status 0 or 1 8. Provides written informed consent 9. Subjects of reproductive potential must agree to use acceptable birth control methods, as described in protocol Exclusion Criteria: 1. Active, uncontrolled infection 2. Active hepatitis B or hepatitis C 3. HIV Infection 4. Class III/IV cardiovascular disability according to the New York Heart Association Classification (see Appendix 2) 5. Subjects with clinically apparent arrhythmia or arrhythmias who are not stable on medical management within two weeks of enrollment. 6. Pregnant or nursing (lactating) women 7. Patients with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system, and unrelated to leukemia or previous leukemia treatment.
References
Publications (0)
Data not yet available