Back to results

Safety and Efficacy Study of CD22 CAR-T Cells for Relapsed or Refractory Acute Lymphoblastic Leukemia

Primary Purpose

B-ALL

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

CD22 CAR-T

About this trial

This is an interventional treatment trial for B-ALL focused on measuring CD22 CAR-T， B-ALL

Eligibility Criteria

2 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with relapsed and refractory acute B-lymphoblastic leukemia who have any of the following:
1. 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;
2. Primary B-ALL patients who can not be completely relieved by more than two times of repeated chemotherapy;
3. 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.

Exclusion Criteria:

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）

Sites / Locations

Hebei yanda Ludaopei HospitalRecruiting
BeiJing Ludaopei HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CD22 CAR-T

Arm Description

Patients will be treated with CD22 CAR-T cells

Outcomes

Primary Outcome Measures

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

Efficacy: Remission Rate

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

Secondary Outcome Measures

Efficacy:duration of response (DOR)

duration of response (DOR)

Efficacy: progression-free survival (PFS)

progression-free survival (PFS) time

CAR-T proliferation

the copy number of CD19 CAR- T cells in the genomes of PBMC by qPCR method and percentage of CD19 CAR- T cells measured by flow cytometry method

Cytokine release

Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry method

Full Information

NCT ID

NCT04546906

First Posted

September 4, 2020

Last Updated

September 4, 2020

Sponsor

Hebei Senlang Biotechnology Inc., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04546906

Brief Title

Safety and Efficacy Study of CD22 CAR-T Cells for Relapsed or Refractory Acute Lymphoblastic Leukemia

Official Title

Safety and Efficacy Study of CD22 CAR-T Cells for Relapsed or Refractory Acute Lymphoblastic Leukemia

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Unknown status

Study Start Date

September 1, 2020 (Actual)

Primary Completion Date

September 1, 2022 (Anticipated)

Study Completion Date

December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hebei Senlang Biotechnology Inc., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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

Detailed Description

The CARs consist of an anti-CD22 single-chain variable fragment（scFv）, a portion of the human CD137（4-1BB） molecule, and the intracellular component of the human CD3ζ molecule. 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. The Main research objectives: To evaluate the safety and efficacy of CD22CAR-T in patients with recurrent or refractory B-ALL The Secondary research objectives: To investigate the cytokinetic characteristics of CD22CAR-T in patients with recurrent or refractory B-ALL

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

B-ALL

Keywords

CD22 CAR-T， B-ALL

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CD22 CAR-T

Arm Type

Experimental

Arm Description

Patients will be treated with CD22 CAR-T cells

Intervention Type

Biological

Intervention Name(s)

CD22 CAR-T

Intervention Description

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

Primary Outcome Measure Information:

Title

Safety: Incidence and severity of adverse events

Description

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

Time Frame

First month post CAR-T cells infusion

Title

Efficacy: Remission Rate

Description

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

Time Frame

3 months post CAR-T cells infusion

Secondary Outcome Measure Information:

Title

Efficacy:duration of response (DOR)

Description

duration of response (DOR)

Time Frame

24 months post CAR-T cells infusion

Title

Efficacy: progression-free survival (PFS)

Description

progression-free survival (PFS) time

Time Frame

24 months post CAR-T cells infusion

Title

CAR-T proliferation

Description

the copy number of CD19 CAR- T cells in the genomes of PBMC by qPCR method and percentage of CD19 CAR- T cells measured by flow cytometry method

Time Frame

3 months post CAR-T cells infusion

Title

Cytokine release

Description

Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry method

Time Frame

First month post CAR-T cells infusion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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）

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Peihua Lu, PhD&MD

Phone

008618611636172

peihua_lu@126.com

First Name & Middle Initial & Last Name or Official Title & Degree

Jianqiang Li, PhD&MD

Phone

008615511369555

limmune@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peihua Lu, PhD&MD

Organizational Affiliation

Hebei Yanda Ludaopei Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hebei yanda Ludaopei Hospital

City

Heibei

State/Province

Sanhe

ZIP/Postal Code

065200

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Peihua Lu, PhD&MD

Phone

008618611636172

peihua_lu@126.com

First Name & Middle Initial & Last Name & Degree

Peihua Lu, PhD&MD

First Name & Middle Initial & Last Name & Degree

Jianqiang Li, PhD&MD

Facility Name

BeiJing Ludaopei Hospital

City

Beijing

State/Province

Yizhuang

ZIP/Postal Code

100000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Peihua Lu, PhD&MD

Phone

008618611636172

peihua_lu@126.com

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy Study of CD22 CAR-T Cells for Relapsed or Refractory Acute Lymphoblastic Leukemia

We'll reach out to this number within 24 hrs