Status:
ACTIVE_NOT_RECRUITING
Bispecific CD19/CD22 CAR-T for Treatment of Children and Young Adults With r/r B-ALL
Lead Sponsor:
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Conditions:
B-ALL
Eligibility:
All Genders
3-25 years
Phase:
PHASE1
PHASE2
Brief Summary
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...
Detailed Description
The main objectives of the study are: * To investigate the incidence of adverse events of grade 3-5 within after CD19/CD22 CAR lymphocyte infusion by day 28, * To evaluate the incidence of complete r...
Eligibility Criteria
Inclusion
- 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
- \<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
Key Trial Info
Start Date :
July 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 13 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04499573
Start Date
July 27 2020
End Date
March 13 2027
Last Update
February 22 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Moscow, Russia, 117198