NCT04546893

Brief Summary

This is an open, single-arm, clinical study to evaluate efficacy and safety of anti CD19 CAR-T cell in the treatment of recurrent or refractory B-ALL

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
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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

September 1, 2020

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 4, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 14, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

September 14, 2020

Status Verified

September 1, 2020

Enrollment Period

2 years

First QC Date

September 4, 2020

Last Update Submit

September 4, 2020

Conditions

B-ALL

Keywords

B-ALL, CD19 CAR-T

Outcome Measures

Primary Outcomes (2)

  • Safety: Incidence and severity of adverse events

    To evaluate the possible adverse events occurred within first one month after SL1904B 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)、CR with incomplete blood count recovery(CRi)、No remission(NR)

    3 months post CAR-T cells infusion

Secondary Outcomes (4)

  • Efficacy:duration of response (DOR)

    24 months post CAR-T cells infusion

  • Efficacy: progression-free survival (PFS)

    24 months post CAR-T cells infusion

  • CAR-T proliferation

    3 months post CAR-T cells infusion

  • Cytokine release

    First month post CAR-T cells infusion

Study Arms (1)

1904B CAR-T

EXPERIMENTAL

Patients will be treated with CD19 CAR-T cells

Biological: CD19 CAR-T

Interventions

CD19 CAR-TBIOLOGICAL

Biological: CD19 CAR-T; Drug: Cyclophosphamide,Fludarabine; Procedure: Leukapheresis;

1904B CAR-T

Eligibility Criteria

Age2 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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;
  • A definite diagnosis of B-cell Lymphocyte Leukemia, which meets any of the following criteria: Relapsed : a) relapsed within 12 months after first remission;Refractory: a) no remission after six weeks of induction therapy or no remission after two courses of induction therapy; b) relapsedafter CR for 2 or more times; c) The first relapse after chemotherapy and no remission after at least one salvage treatment; c) relapsed after hematopoietic stem cell transplantation;
  • ECOG Scores: 0\~2
  • CD19 positivewere detected by immunohistochemistry or flow cytometry;
  • Estimated survival time\>3 months;
  • Peripheral blood mononuclear immune cells must be collected at least 2 weeks after the last radiotherapy or systemic treatment.

You may not qualify if:

  • Serious cardiac insufficiency；
  • Has a history of severe pulmonary function damaging;
  • With other tumors which is/are in advanced malignant and has/have systemic metastasis;
  • Severe or persistent infection that cannot be effectively controlled；
  • Merging severe autoimmune diseases or immunodeficiency disease;
  • Patients with active hepatitis B or hepatitis C(\[HBVDNA+\]or \[HCVRNA+\]);
  • Patients with HIV infection or syphilis infection;
  • Has a history of serious allergies on Biological products (including antibiotics);
  • Being pregnant and lactating or having pregnancy within 12 months;
  • Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hebei yanda Ludaopei Hospital

Hebei, Sanhe, 065200, China

RECRUITING

BeiJing Ludaopei Hospital

Beijing, Yizhuang, 100000, China

RECRUITING

Study Officials

  • Peihua Lu, PhD&MD

    Hebei Yanda Ludaopei Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peihua Lu, PhD&MD

CONTACT

008618611636172peihua_lu@126.com

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

September 4, 2020

First Posted

September 14, 2020

Study Start

September 1, 2020

Primary Completion

September 1, 2022

Study Completion

December 1, 2022

Last Updated

September 14, 2020

Record last verified: 2020-09

Locations

CN(2)