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NCT04499573Active, not recruitingPhase 1/2

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

Source: ClinicalTrials.gov · Last updated 22 Feb 2023

Brief summary (registry, in English)

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

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
50 (estimated)
First submitted
31 Jul 2020
Start date
27 Jul 2020
Primary completion date
13 Mar 2022
Lead sponsor
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
NCT number
NCT04499573

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 50
  • From 27 Jul 2020 to the primary completion date, 13 Mar 2022
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Moderate/severe chronic GVHD (NIH consensus) requiring systemic steroids

Other illness

  • Active (detectable viremia) hepatitis B, C or HIV infection
  • 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)
  • Active (unresolved) severe infection

Lab values

  • Bilirubin \>3x upper norma limit
  • Creatinine \>3x upper norma limit

Other

  • \<50% expression of both CD19 and CD22 on the leukemic population
  • Oxygen saturation ≤ 90%
  • Active acute GVHD overall grade ≥2 (Seattle criteria)
  • Pregnant or lactating women.

Who the study is looking for

  • 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)

Age in the registry: 3 months to 25 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Coordinator of this site? Confirm its status		MoscowRussiaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.