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

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

Study Overview

• Status: Recruiting
• Conditions: Lymphoma; Leukemia
• Intervention / Treatment: Biological: Auto CAR-T; Drug: Cyclophosphamide,Fludarabine; Procedure: Leukapheresis

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • Recruiting
      • Pediatric hematology, Hebei Medical University Fourth Hospital
      • Contact: Lian Jiang, MD
      • Principal Investigator: Lian Jiang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Auto CAR-T; Patients will be treated with Auto CAR-T cells	Biological: Auto CAR-T; Biological: Auto CAR-T; Drug: Cyclophosphamide,Fludarabine; Drug: Cyclophosphamide,Fludarabine; Procedure: Leukapheresis; Leukapheresis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy:duration of response (DOR)	duration of response (DOR)	24 months post CAR-T cells infusion
Efficacy: progression-free survival (PFS)	progression-free survival (PFS) time	24 months post CAR-T cells infusion

Collaborators and Investigators

• Sponsor: Hebei Senlang Biotechnology Inc., Ltd.
• Collaborators: Hebei Medical University Fourth Hospital
• Investigators: Principal Investigator: Lian Jiang, MD, Hebei Medical University Fourth Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 23, 2020
• Primary Completion (ANTICIPATED): June 22, 2023
• Study Completion (ANTICIPATED): June 22, 2025

Study Registration Dates

• First Submitted: October 26, 2020
• First Submitted That Met QC Criteria: October 29, 2020
• First Posted (ACTUAL): October 30, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 30, 2020
• Last Update Submitted That Met QC Criteria: October 29, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Cyclophosphamide; Fludarabine
• Other Study ID Numbers: Children CAR-T

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No