Clinical trial NCT04610125: Clinical Trial of CAR-T in the Treatment of Relapsed and Refractory Hematopoietic and Lymphoid Tissue Tumors in Children
Official title: Clinical Trial of CAR-T in the Treatment of Relapsed and Refractory Hematopoietic and Lymphoid Tissue Tumors in Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Leukemia
Lymphoma
Lead sponsor: Hebei Senlang Biotechnology Inc., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Hebei Medical University Fourth Hospital
First posted: 2020-10-30
Enrollment: 30
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: This is an open, single-arm, prospective，clinical study to evaluate efficacy and safety of Auto CAR-T cell injection in the treatment of recurrent or refractory Hematopoietic and Lymphoid Tissue Tumors in Children

Detailed description: A single car consists of scFv, hinge region, transmembrane region, costimulatory domain and zeta subunit of CD3.Prior to CAR-T cell infusion, the patients will be subjected to preconditioning treatment. After CAR-T cell infusion, the patients will be evaluated for adverse reactions and efficacy.

Eligibility criteria: Inclusion Criteria:

1. Sign the informed consent and be willing and able to comply with the visit, treatment regimen, laboratory examination and other requirements of the study as stipulated in the trial flow chart;
2. Patients with relapsed and refractory hematopoiesis and lymphoid tissue tumors confirmed by clinical diagnosis;
3. Age: 1-18 years (including boundary value), both male and female;
4. Subjects with Lansky score ≥ 50;
5. The results of treatment-related antigens were positive;
6. The expected survival time is more than 3 months from the date of signing the informed consent.

Exclusion Criteria:

1. Severe cardiac insufficiency and left ventricular ejection fraction \< 50%;
2. He had a history of severe lung function damage;
3. Combined with other advanced malignant tumors;
4. Severe infection was found and could not be effectively controlled;
5. With metabolic diseases (except diabetes mellitus);
6. Combined with severe autoimmune disease or congenital immunodeficiency;
7. Untreated active hepatitis (hepatitis B, defined as positive HBsAg, HBV-DNA ≥ 500 IU / ml and abnormal liver function; hepatitis C, defined as hepatitis C antibody \[HCV AB\] positive, HCV-RNA higher than the detection limit of the analysis method and abnormal liver function) or combined with hepatitis B and hepatitis C co infection;
8. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection;
9. Severe allergy history of biological products (including antibiotics);
10. Patients with acute graft-versus-host reaction (GVHD) after one month of discontinuation of immunosuppressants were still present;
11. The presence of other serious physical or mental illness or laboratory abnormalities that may increase the risk of participating in the study, or interfere with the results of the study, and patients considered unsuitable for the study by the investigator.

Primary outcomes:
measure: Safety: Incidence and severity of adverse events
timeFrame: First month post CAR-T cells infusion
measure: Efficacy: Remission Rate
timeFrame: 3 months post CAR-T cells infusion
Secondary outcomes:
measure: Efficacy:duration of response (DOR)
timeFrame: 24 months post CAR-T cells infusion
measure: Efficacy: progression-free survival (PFS)
timeFrame: 24 months post CAR-T cells infusion
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: Pediatric hematology, Hebei Medical University Fourth Hospital
state: Hebei
Study officials:
affiliation: Hebei Medical University Fourth Hospital
name: Lian Jiang, MD
role: PRINCIPAL_INVESTIGATOR
References: