Clinical trial · Interventional
Bispecific CD19/CD22 CAR-T for Treatment of Children and Young Adults With r/r B-ALL
Safety and Efficiency of Anti-CD19/CD22 Tandem Fully Human Chimeric Antigen Receptor (CAR)-Transduced T-cell Therapy for Pediatric and Young Adult Patients With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia: a Single Centre, Non-randomised, Open Label Phase I-II Clinical Trial of Automatically Produced Cell Therapy Product MB-CAR-T19-22 Using CliniMACS Prodigy
NCT04499573CI-TRIAL-00064161active not recruitingPhase 1 / Phase 2ClinicalTrials.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)
The purpose of this study is to evaluate the safety and efficiency of autologous CD19/CD22 CAR-T lymphocytes in a cohort of pediatric and young adult patients with relapsed /refractory B-lineage 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 |
|---|---|---|---|
| B-ALL | B Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CD19/CD22 CAR-T | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- intervention/treatment
- description
- Intervention: 1. Patient (cohort 1 and 2) or donor (cohort 3) leukapheresis 2. Drug therapy: * Fludarabine 120 mg/m2 * Cyclophosphamide 750 mg/m2 * Etoposide 450 mg/m2 * Cytarabine 900 mg/m2 * Dexamethasone 30 mg/m2 * Tocilizumab 8 mg/kg BW 3. Biological: Cohort 1 and 2: autologous CD19/CD22 CAR-T lymphocytes, dose 0.15 - 1.5х106/kg Cohort 3: allogeneic CD19/CD22 CAR-T lymphocytes, dose 0.1х106/kg + allogeneic HSCT from a haploidentical or matched related donor
- interventionNames
- Drug: CD19/CD22 CAR-T
Primary outcomes (7)
- measure
- incidence of grade 3-5 SAE
- timeFrame
- 1 month
- description
- Safety: Toxicity evaluation following CD19/CD22 CAR T-cell infusion: \- incidence of grade 3-5 SAE (according CTCAE v.5.0)
- measure
- incidence of grade 3-5 Severe Cytokine Release Syndrome
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Months
- Maximum age
- 25 Years
Show eligibility criteria text
Inclusion Criteria: * Ability to give informed consent (for patients \> 14 years old). For subjects \< 18 years old their legal guardian must give informed consent * CD19 or CD22 expression must be detected on greater than 50% of leukemic cells by flow cytometry * Presence of a measurable mass of tumor cells in the bone marrow or extramedullary sites at the time of patient's inclusion in the study * Patients with relapsed or refractory CD19 and CD22-expressing B-cell ALL: * Induction failure * MRD ≥ 0,1% after 2nd chemotherapy course for high-risk group patients. * First bone marrow or combined relapse of acute lymphoblastic leukemia, no CR or MRD ≥ 0,1% after 1-course 2nd line therapy * Second and further relapse of ALL * Relapse or MRD ≥ 0,1% of ALL after hematopoietic stem cell transplant (\> 60 days post alloHSCT)o There must be no available alternative approved curative therapies * Patient Clinical Performance Status: Karnofsky \>50% or Lansky \>50% * Patient Life Expectancy \> 4 weeks * Patients recovered from acute toxic effects of prior chemotherapy, immune- or radiotherapy * Patient absolute blood naïve (CD45RA+) T-lymphocyte count ≥ 50/mm3 * Patient cardiac function left ventricular ejection fraction greater than or equal to 40% by MUGA or cardiac MRI, or fractional shortening greater than or equal to 28% by ECHO or left ventricular ejection fraction greater than or equal to 50% by ECHO. * Patients who agree to long-term follow up for up to 5 years (if received CD19/CD22 CAR-T cell infusion) * March 2021 amendment: Healthy HLA-matched related or haploidentical donor (only for HSCT cohort) Exclusion Criteria: * \<50% expression of both CD19 and CD22 on the leukemic population * Active (detectable viremia) hepatitis B, C or HIV infection * Oxygen saturation ≤ 90% * Bilirubin \>3x upper norma limit * Creatinine \>3x upper norma limit * Active acute GVHD overall grade ≥2 (Seattle criteria) * Moderate/severe chronic GVHD (NIH consensus) requiring systemic steroids * Clinical signs of grade \> 3 CNS disorders (seizure disorder, paresis, aphasia, cerebrovascular, ischemia/hemorrhage, severe brain injuries, dementia, cerebellar disease, organic brain syndrome, psychosis, coordination or movement disorder) * Pregnant or lactating women. * Active (unresolved) severe infection
References
Publications (0)
Data not yet available
No reference posted for this study.