NCT05225831

Brief Summary

This is an open, single-arm, prospective clinical study to evaluate the safety and efficacy of anti CD19 and CD22 CAR-T cell in the treatment of R/R 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
100

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Aug 2021

Typical duration for early_phase_1

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

August 15, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2022

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 7, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

February 7, 2022

Status Verified

January 1, 2022

Enrollment Period

2 years

First QC Date

January 11, 2022

Last Update Submit

January 25, 2022

Conditions

CD19+ and CD 22+ B-ALL

Keywords

CD19CD22B-ALLCAR-T

Outcome Measures

Primary Outcomes (2)

  • Safety: Incidence of adverse events

    To evaluate the possible adverse events that could occurred within the first month post SL19+22 infusion, including symptoms such as cytokine release syndrome and neurotoxicity.

    up to 28 days

  • Efficacy: Remission Rate

    Remission Rate includes complete remission(CR)、CR with incomplete blood count recovery(CRi)、No remission(NR)

    Up to 3 months

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)

SL19+22 CAR-T

EXPERIMENTAL

Eligible patients will be treated with SL19+22 CAR-T.

Biological: Autologous CD19/CD22 Chimeric Antigen Receptor T-cellsDrug: Cyclophosphamide,Fludarabine

Interventions

Autologous CD19/CD22 Chimeric Antigen Receptor T-cellsBIOLOGICAL

A single infusion of CD19 and CD22 CAR-T cells.

Also known as: SL19+22 CAR-T
SL19+22 CAR-T
Cyclophosphamide,FludarabineDRUG

Given

SL19+22 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:

  • 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 positive and CD22 positive were 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.
  • For patients with only extramedullary recurrence of B-ALL, there must be at least one assessable lesion.

You may not qualify if:

  • Serious cardiac insufficiency；
  • Has a history of severe pulmonary function damaging;
  • Presence of other malignant tumors.
  • Presence of active fungal, bacterial, viral, or other infection requiring IV antibiotics for management.
  • Presence of other severe autoimmune diseases or immunodeficiency disease;
  • Patients with active hepatitis B or hepatitis C(\[HBVDNA+\]or \[HCVRNA+\]);
  • Known positive serology for human immunodeficiency virus (HIV) or syphilis。
  • Has a history of serious allergies on biological products (including antibiotics);
  • Female patients who are under pregnancy and/or lactation, or planing on pregnancy for the next 12 months.
  • Any other situations that the researchers believe will affect the results of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hebei Yanda Ludaopei Hospital

Langfang, Hebei, China

RECRUITING

MeSH Terms

Interventions

CF regimen

Study Officials

  • Peihua Lu, PhD&MD

    Beijing Lu Daopei 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
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2022

First Posted

February 7, 2022

Study Start

August 15, 2021

Primary Completion

August 1, 2023

Study Completion

November 1, 2023

Last Updated

February 7, 2022

Record last verified: 2022-01

Locations

CN(1)