NCT04610125

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for not_applicable leukemia

Timeline
Completed

Started Jun 2020

Typical duration for not_applicable leukemia

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 23, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 30, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2025

Completed
Last Updated

October 30, 2020

Status Verified

August 1, 2020

Enrollment Period

3 years

First QC Date

October 26, 2020

Last Update Submit

October 29, 2020

Conditions

LeukemiaLymphoma

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Efficacy:duration of response (DOR)

    24 months post CAR-T cells infusion

  • Efficacy: progression-free survival (PFS)

    24 months post CAR-T cells infusion

Study Arms (1)

Auto CAR-T

EXPERIMENTAL

Patients will be treated with Auto CAR-T cells

Biological: Auto CAR-TDrug: Cyclophosphamide,FludarabineProcedure: Leukapheresis

Interventions

Auto CAR-TBIOLOGICAL

Biological: Auto CAR-T

Auto CAR-T
Cyclophosphamide,FludarabineDRUG

Drug: Cyclophosphamide,Fludarabine

Auto CAR-T
LeukapheresisPROCEDURE

Leukapheresis

Auto CAR-T

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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;
  • Patients with relapsed and refractory hematopoiesis and lymphoid tissue tumors confirmed by clinical diagnosis;
  • Age: 1-18 years (including boundary value), both male and female;
  • Subjects with Lansky score ≥ 50;
  • The results of treatment-related antigens were positive;
  • The expected survival time is more than 3 months from the date of signing the informed consent.

You may not qualify if:

  • Severe cardiac insufficiency and left ventricular ejection fraction \< 50%;
  • He had a history of severe lung function damage;
  • Combined with other advanced malignant tumors;
  • Severe infection was found and could not be effectively controlled;
  • With metabolic diseases (except diabetes mellitus);
  • Combined with severe autoimmune disease or congenital immunodeficiency;
  • 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;
  • Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection;
  • Severe allergy history of biological products (including antibiotics);
  • Patients with acute graft-versus-host reaction (GVHD) after one month of discontinuation of immunosuppressants were still present;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric hematology, Hebei Medical University Fourth Hospital

Shijiazhuang, Hebei, 050000, China

RECRUITING

MeSH Terms

Conditions

LeukemiaLymphoma

Interventions

CF regimenLeukapheresis

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

CytapheresisBiological TherapyTherapeuticsBlood Component RemovalLeukocyte Reduction ProceduresCell SeparationCytological TechniquesClinical Laboratory TechniquesInvestigative Techniques

Study Officials

  • Lian Jiang, MD

    Hebei Medical University Fourth Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianqiang Li, PhD&MD

CONTACT

008615511369555limmune@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2020

First Posted

October 30, 2020

Study Start

June 23, 2020

Primary Completion

June 22, 2023

Study Completion

June 22, 2025

Last Updated

October 30, 2020

Record last verified: 2020-08

Locations

CN(1)