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

Early Phase 1

• Conditions: Childhood Acute Lymphoblastic Leukemia
• Interventions: Drug: CD19 CAR-T; Drug: CD22 CAR-T; Drug: CD 19+22; Drug: Fludarabine; Drug: Cyclophosphamide

• Registration Number: NCT04626765
• Lead Sponsor: Hebei Senlang Biotechnology Inc., Ltd.

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.

Study Timeline

• Study Start: 2020-04-01
• Status Verified: 2020-11
• Study First Submitted: 2020-11-06
• Study First Submitted QC: 2020-11-11
• Last Update Submitted: 2020-11-11
• Study First Posted: 2020-11-13
• Last Update Posted: 2020-11-13
• Primary Completion: 2023-03-30
• Study Completion: 2023-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
volunteer	CD19 CAR-T	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
volunteer	CD22 CAR-T	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
volunteer	CD 19+22	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
volunteer	Fludarabine	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
volunteer	Cyclophosphamide	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

Primary Outcome Measures

Name	Time	Method
Number of Participants with Severe/Adverse Events	28 days	Number of Participants with Severe/Adverse Events as a Measure of Safety diagnosis
CAR-T Cell expansion level	24 months	Copies numbers of CAR in peripheral blood(PB) and/or bone marrow(BM)

Secondary Outcome Measures

Name	Time	Method
Objective response rate of complete remission and partial remission	24 months	Objective response rate of complete remission and partial remission
Overall survival time	24 months	Overall survival time

Trial Locations

Locations (1)

No.2 Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China