Clinical trial NCT04626765: CAR-T for Children With Relapsed and Refractory Acute Lymphoblastic Leukemia
Official title: An Open, Uncontrolled, Multicenter Clinical Trial to Explore the Safety, Efficacy, and Remission Phase of Chimeric Antigen Receptor T Cell (CAR-T) in the Treatment of Children With Relapsed and Refractory Acute Lymphoblastic Leukemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Childhood Acute Lymphoblastic Leukemia
Lead sponsor: Hebei Senlang Biotechnology Inc., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: The Second Hospital of Hebei Medical University
First posted: 2020-11-13
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this study, CAR-T will be administered to children with acute lymphoblastic leukemia to explore the effect of CAR-T intervention time on the duration of complete remission and further verify the long-term safety and efficacy of CAR-T treatment.

Detailed description: After clinician evaluation, if the child meets the study criteria and after adequate communication, the parent or legal guardian voluntarily joins the clinical study, CAR-T technique can be used for related treatment, and the long-term therapeutic effect can be observed. In this trial, 50 children were publicly enrolled and treated with CAR-T. Patients participating in the clinical trial will be tested and assessed in terms of treatment safety, efficacy, and duration of response.

Eligibility criteria: Inclusion criteria：

1. The treat history meeting the following criteria:

   Recurrence of lymphoma patients with imaging (CT/MRI/PET-CT) detection and pathological diagnosis, or recurrence including bone marrow morphology relapse and the MRD recurrence of myeloma patients or leukemia patients, after chemotherapy or stem cell transplantation; Can't get complete remission (including MRD positive) after more than twice repeated chemotherapy of incipient lymphoma, myeloma or leukemia patients; One or twice chemotherapy cannot get remission again (including MRD positive), but not suitable for chemotherapy of incipient lymphoma, myeloma or leukemia patients.
2. There is a measurable lesions before treatment at least;
3. ECOG score≤2;
4. To be aged 1 to 18 years;
5. More than a month lifetime from the consent signing date

Exclusion Criteria:

1. Serious cardiac insufficiency, left ventricular ejection fraction\<50%;
2. Has a history of severe pulmonary function damaging;
3. Merging other progressing malignant tumor;
4. Merging uncontrolled infection;
5. Merging the metabolic diseases (except diabetes);
6. Merging severe autoimmune diseases or immunodeficiency disease;
7. Patients with active hepatitis B or hepatitis C;
8. Patients with HIV infection;
9. Has a history of serious allergies on Biological products (including antibiotics);
10. Has acute GvHD on allogeneic hematopoietic stem cell transplantation patients after stopping immunosuppressants a month;
11. Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.

Primary outcomes:
measure: Number of Participants with Severe/Adverse Events
timeFrame: 28 days
measure: CAR-T Cell expansion level
timeFrame: 24 months
Secondary outcomes:
measure: Objective response rate of complete remission and partial remission
timeFrame: 24 months
measure: Overall survival time
timeFrame: 24 months
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: No.2 Hospital of Hebei Medical University
state: Hebei
Study officials:
affiliation: The Second Hospital of Hebei Medical University
name: Jianmin Luo, PhD&MD
role: PRINCIPAL_INVESTIGATOR
References: