To hear about similar clinical trials, please enter your email below
Trial Title:
Clinical Trial of CD19 and CD22 CAR Sequential Therapy Versus Single CD19 CAR Bridging to HSCT for r/r B-ALL Patients
NCT ID:
NCT06343090
Condition:
B-cell Acute Lymphoblastic Leukemia
Acute Lymphoblastic Leukemia, in Relapse
Refractory Acute Lymphoid Leukemia
Conditions: Official terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
a prospective cohort study
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
CD19 CAR T-cell
Description:
Murine-derived CD19 CAR T cells
Arm group label:
Arm-1: CD19 CAR T and CD22 CAR T-cell sequential treatments (Sequential CAR)
Arm group label:
Arm-2: CD19 CAR T-cell treatment bridging to HSCT (CAR+HSCT)
Intervention type:
Drug
Intervention name:
CD22 CAR T cells
Description:
humanized CD22 CAR T cells
Arm group label:
Arm-1: CD19 CAR T and CD22 CAR T-cell sequential treatments (Sequential CAR)
Intervention type:
Procedure
Intervention name:
hematopoietic stem-cell transplantation
Description:
allo-HSCT
Arm group label:
Arm-2: CD19 CAR T-cell treatment bridging to HSCT (CAR+HSCT)
Summary:
This is a multi-center, open-label, non-randomized, two-arm, non-inferior trial. Patients
with r/r B-ALL would be assigned to the CD19 CAR and CD22 CAR T-cell sequential infusion
group (Sequential CAR, Arm-1) and the CD19 CAR T-cell infusion bridging to hematopoietic
stem cell transplantation group (CAR+HSCT, Arm-2), according their own discretion.
Patients would be also allowed to assigned to the CD19 CAR T-cell infusion without
consolidation therapies group (Single CAR, additional placebo arm) according their own
discretion. The primary objective is to prospectively evaluate and compare the efficacy
of CD19 CAR and CD22 CAR T cell sequential infusions and CD19 CAR T-cell infusion
bridging to HSCT in the treatment of r/r B-ALL. The primary endpoint is event-free
survival of children and adolescent and young adult (AYA) with r/r B-ALL a treated with
CD19 CAR and CD22 CAR T-cell sequential infusions and CD19 CAR T-cell infusion bridging
to HSCT. A total number of 353 subjects will be enrolled.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Only patients who meet all the following criteria can be included in the group:
1. Patients who were diagnosed as primary refractory or relapsed B-ALL.
(Criterion-reference: NCCN, version 2.2023); All the patients matched the
diagnostic criteria of ALL according to the NCCN guideline (≥20% bone marrow
lymphoblasts on hematopathology review of bone marrow aspirate and biopsy
materials, which were confirmed by comprehensive flow cytometric
immunophenotyping, minimal residual disease analysis and karyotyping of
G-banded metaphase chromosomes). Molecular characterization could be obtained
via interphase fluorescence in situ hybridization (FISH) testing, reverse
transcriptase polymerase chain reaction (RT-PCR) testing, comprehensive testing
by next-generation sequencing (NGS) for gene fusions and pathogenic mutations,
etc. Determination of the World Health Organization ALL subtypes and
cytogenetic and clinical risk groups were also allowed. B-ALL patients who did
not achieve a complete remission after previous therapy (including the various
treatment response scenarios shown in Table 1), who did not achieve a complete
remission after at least two lines of TKI agents (including the various
treatment response scenarios shown in Table 1), or who had ≥1 relapses were
defined as having refractory or relapsed disease. Patients who were diagnosed
as CD19- and CD22-positive high-risk B-ALL with continuous positive minimal
residual disease (MRD) for more than three months after last therapy were also
eligible. Patients had positive CD19 and CD22 expression on leukemia blasts by
FCM (>80% CD19 and CD22 positive);
2. Age from 1 to 39 years old;
3. No serious allergic constitution;
4. Eastern Cooperative Oncology Group (ECOG) performance status (Oken et al.,
1982) score 0 to 2;
5. Have life expectancy of at least 60 days based on investigator's judgement;
6. Voluntary informed consent is signed by self-aware patients aged 8-39 years and
by legal representatives (guardians) of pediatric patients under 18 years of
age.
Exclusion Criteria:
- Patients with at least one of the following conditions are excluded:
1. Intracranial hypertension or unconscious;
2. Acute heart failure or severe arrhythmia;
3. Acute respiratory failure;
4. Other types of malignant tumors;
5. Diffuse intravascular coagulation;
6. Serum creatinine and/or blood urea nitrogen over 1.5 times the normal value;
7. Sepsis or other uncontrolled infection;
8. Uncontrolled diabetes mellitus;
9. Severe psychological disorder;
10. Obvious cranial lesions by cranial MRI;
11. More than 20 leukemic cells/μL in cerebrospinal fluid;
12. More than 30% leukemic cells in the peripheral blood;
13. Organ recipients;
14. Pregnant or breastfeeding;
15. Active, uncontrolled infection, including hepatitis B virus (HBV), hepatitis C
virus (HCV), human immunodeficiency virus (HIV) or treponema pallidum (TP).
Gender:
All
Minimum age:
1 Year
Maximum age:
39 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing GoBroad Hospital
Address:
City:
Beijing
Zip:
102206
Country:
China
Status:
Recruiting
Contact:
Last name:
Tengyu Wang
Phone:
86+18333186020
Email:
tengyu.wang@gohealtharo.com
Start date:
April 12, 2024
Completion date:
September 30, 2043
Lead sponsor:
Agency:
Beijing GoBroad Hospital
Agency class:
Other
Source:
Beijing GoBroad Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06343090
