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

Childhood Acute Lymphoblastic Leukemia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04626765
• Other study ID #: CAR-T for Childhood B-ALL
• Status: Recruiting
• Phase: Early Phase 1
• Start date: April 1, 2020
• Est. completion date: May 30, 2023

Study information

• Verified date: November 2020
• Source: Hebei Senlang Biotechnology Inc., Ltd.
• Contact: Jianqiang Li, PhD&MD
• Phone: +8631189928689
• Email: limmune[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 30, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Childhood Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• CD19 CAR-T
CD19 CAR-T infusion for pediatric patients with CD19 positive tumor cells
• CD22 CAR-T
CD22 CAR-T infusion for pediatric patients with CD22 positive tumor cells
• CD 19+22
CD19+22 CAR-T infusion for pediatric patients with CD19 positive and CD22 positive tumor cells
• Fludarabine
25mg/? for D-4?D-3 and D-2
• Cyclophosphamide
500mg/? for D-3 and D-2

Locations

Country	Name	City	State
China	No.2 Hospital of Hebei Medical University	Shijiazhuang	Hebei

Sponsors (2)

Lead Sponsor	Collaborator
Hebei Senlang Biotechnology Inc., Ltd.	The Second Hospital of Hebei Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Severe/Adverse Events	Number of Participants with Severe/Adverse Events as a Measure of Safety diagnosis	28 days
Primary	CAR-T Cell expansion level	Copies numbers of CAR in peripheral blood(PB) and/or bone marrow(BM)	24 months
Secondary	Objective response rate of complete remission and partial remission	Objective response rate of complete remission and partial remission	24 months
Secondary	Overall survival time	Overall survival time	24 months