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Trial Title:
Safety, Tolerability, and Pharmacokinetics of Donor-derived CD19 CAR Therapy Bridged Allo-HSCT and Sequential Donor-derived CD22 CAR Therapy for r/r B-ALL: a Clinical Trial
NCT ID:
NCT06326008
Condition:
B-cell Acute Lymphoblastic Leukemia
Acute Lymphoblastic Leukemia, in Relapse
Conditions: Official terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Donor-derived CD19 CAR Therapy Bridged Allo-HSCT and Sequential Donor-derived CD22 CAR Therapy
Description:
Peripheral blood mononuclear cells for the production of CD19 CAR T cells and CD22 CAR T
cells are collected from donors and haematopoietic stem cells are collected from donors.
Arm group label:
Arm-1
Summary:
This is an investigator-initiated, single-arm, open-label, non-randomised phase I
clinical study. The objective of this trial is to evaluate the safety, tolerability and
pharmacokinetics of donor-derived CD19 CAR Therapy bridged Allo-HSCT and sequential
donor-derived CD22 CAR Therapy for r/r B-ALL and to explore the efficacy of this therapy
preliminarily. The primary endpoints are incidence and type of dose-limiting toxicity
(DLT) within 28 days (i.e., 43 days after donor-derived CD19 CAR T-cell infusion) after
donor-derived CD19 CAR T-cell therapy bridged allogeneic haematopoietic stem cell
transplantation; total number, incidence and severity of adverse events from
donor-derived CD19 CAR T cell infusion back to 30 days after donor-derived CD22 CAR T
cell infusion (i.e., within 120 days of donor-derived CD19 CAR T cell infusion). The
secondary endpoints are total number, incidence and severity of adverse events from 120
days to 2 years after donor-derived CD19 CAR T-cell infusion; ORR(CR+CRi) on days 45, 90,
120; duration of response(DOR), event-free survival(EFS), overall survival(OS);
pharmacokinetics characteristics. The trial plan to enroll 3~12 cases in dose escalation
phase and 36 cases in dose expansion phase.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients will be enrolled only if they meet all the inclusion criteria.
1. Patients with relapsed or refractory CD19+/CD22+ (FCM >95%) B-cell acute
lymphoblastic leukaemia who have progressed despite or are intolerant to all
standard therapies, including, but not limited to, immunotherapies such as
Blinatumomab (BITE), Tyrosine kinase inhibitors (TKI), CAR T-cell therapy, etc.;
Currently available therapies have a limited prognosis and there are no available
curative treatment options (e.g., HSCT or chemotherapy);
2. Peripheral blood tumour burden ≥60% or severe peripheral blood cytopenia,
unsuitable/unable to collect autologous lymphocytes;
3. 1 to 18 years old;
4. Patient's expected survival time ≥ 60 days;
5. Physical status: ECOG score 0-2;
6. Availability of allogeneic donors (HLA-identical or HLA-haploidentical) DSA-negative
for collection of peripheral blood mononuclear cells and peripheral blood stem
cells;
7. Sign an informed consent form during the screening period. Pediatric patients under
8~18 years of age need to have sufficient awareness to voluntarily sign an informed
consent form, and their legal representatives (guardians) also need to voluntarily
sign an informed consent form; pediatric patients aged 1~7 years can only be
recruited after their legal guardians have voluntarily signed an informed consent
form.
Exclusion Criteria:
- Patients who meet any of the following criteria are not eligible for enrolment.
1. Patients who have received previous haematopoietic stem cell transplantation
(including peripheral blood haematopoietic stem cell transplantation and bone
marrow haematopoietic stem cell transplantation);
2. Intracranial hypertension or cerebral impaired consciousness;
3. Symptomatic heart failure or severe cardiac arrhythmia;
4. Symptoms of severe respiratory failure;
5. With other types of malignant tumours;
6. Diffuse intravascular coagulation;
7. Serum creatinine and/or urea nitrogen ≥ 1.5 times the normal value;
8. Suffering from sepsis or other uncontrollable infections;
9. Suffering from uncontrollable diabetes mellitus;
10. Severe mental disorders;
11. Have significant intracranial lesions on cranial MRI (excluding intracranial
masses caused by central nervous system leukaemia);
12. Have organ transplant history;
13. Female patients (patients of childbearing potential) with positive blood HCG
test;
14. Hepatitis (including Hepatitis B and Hepatitis C) and positive screening for
AIDS and syphilis;
15. No allogeneic donor suitable for collection of peripheral blood lymphocytes and
haematopoietic stem cells.
Gender:
All
Minimum age:
1 Year
Maximum age:
18 Years
Healthy volunteers:
No
Start date:
December 15, 2024
Completion date:
December 30, 2026
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/NCT06326008
