Clinical Trial of CAR-T in the Treatment of Relapsed and Refractory Hematopoietic and Lymphoid Tissue Tumors in Children

Lymphoma Clinical Trial

Official title:

Clinical Trial of CAR-T in the Treatment of Relapsed and Refractory Hematopoietic and Lymphoid Tissue Tumors in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04610125
• Other study ID #: Children CAR-T
• Status: Recruiting
• Phase: N/A
• Start date: June 23, 2020
• Est. completion date: June 22, 2025

Study information

• Verified date: August 2020
• Source: Hebei Senlang Biotechnology Inc., Ltd.
• Contact: Jianqiang Li, PhD&MD
• Phone: 008615511369555
• Email: limmune[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 22, 2025
• Est. primary completion date: June 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Leukemia
• Lymphoma

Intervention

Biological:
• Auto CAR-T
Biological: Auto CAR-T

Drug:
• Cyclophosphamide,Fludarabine
Drug: Cyclophosphamide,Fludarabine

Procedure:
• Leukapheresis
Leukapheresis

Locations

Country	Name	City	State
China	Pediatric hematology, Hebei Medical University Fourth Hospital	Shijiazhuang	Hebei

Sponsors (2)

Lead Sponsor	Collaborator
Hebei Senlang Biotechnology Inc., Ltd.	Hebei Medical University Fourth Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Incidence and severity of adverse events	To evaluate the possible adverse events occurred within first one month after CAR-T infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity	First month post CAR-T cells infusion
Primary	Efficacy: Remission Rate	Remission Rate including complete remission(CR)?partial response(PR)?No remission(NR)?progressive disease(PD)	3 months post CAR-T cells infusion
Secondary	Efficacy:duration of response (DOR)	duration of response (DOR)	24 months post CAR-T cells infusion
Secondary	Efficacy: progression-free survival (PFS)	progression-free survival (PFS) time	24 months post CAR-T cells infusion