NCT04546906

Brief Summary

This is an open, single-arm, clinical study to evaluate efficacy and safety of anti CD22 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

CD22 CAR-T， B-ALL

Outcome Measures

Primary Outcomes (2)

  • Safety: Incidence and severity of adverse events

    To evaluate the possible adverse events occurred within first one month after CD22 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)、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)

CD22 CAR-T

EXPERIMENTAL

Patients will be treated with CD22 CAR-T cells

Biological: CD22 CAR-T

Interventions

CD22 CAR-TBIOLOGICAL

Biological: CD22 CAR-T; Drug: Cyclophosphamide,Fludarabine; Procedure: Leukapheresis

CD22 CAR-T

Eligibility Criteria

Age2 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with relapsed and refractory acute B-lymphoblastic leukemia who have any of the following:
  • B-ALL patients with relapse (including bone marrow morphological relapse 1 and minimal residual relapse 2) after remission by chemotherapy or autologous stem cell transplantation;
  • Primary B-ALL patients who can not be completely relieved by more than two times of repeated chemotherapy;
  • High risk primary B-ALL patients who have not been relieved but are not suitable for re intensive therapy after 1-2 times of chemotherapy;
  • Flow cytometry (FCM) showed CD 22 positive in bone marrow or peripheral blood;
  • There should be at least one assessable lesion in B-ALL patients with simple extramedullary recurrence;
  • The activity state score of the Eastern Cooperative Oncology Group (ECOG) was less than or equal to 2;
  • The estimated survival time is more than 3 months;
  • Need to sign informed consent.

You may not qualify if:

  • Serious cardiac insufficiency；
  • Has a history of severe pulmonary function damaging;
  • Other malignant tumors;
  • Serious infection or persistent infection and can not be effectively controlled；
  • Merging severe autoimmune diseases or immunodeficiency disease;
  • Patients with active hepatitis (HBV DNA or HCV RNA positive);
  • 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（including a history of serious mental illness, substance abuse and addiction）

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hebei yanda Ludaopei Hospital

Heibei, 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)