CAR-T for Children With Relapsed and Refractory Acute Lymphoblastic Leukemia

Hebei Senlang Biotechnology

Status and phase: Unknown; Early Phase 1

Conditions: Childhood Acute Lymphoblastic Leukemia

Treatments: Drug: CD22 CAR-T; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: CD 19+22; Drug: CD19 CAR-T

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04626765

CAR-T for Childhood B-ALL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

volunteer

Experimental group

Description:

The child's parents or legal guardians voluntarily signed the informed consent form, and the child himself/herself met the enter criteria for the diagnosis of patients with acute B-lymphoblastic leukemia (B-ALL) expressing specific target antigens

Treatment:

Drug: CD19 CAR-T

Drug: CD 19+22

Drug: Fludarabine

Drug: Cyclophosphamide

Drug: CD22 CAR-T