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Safety and Efficacy of CD19/CD22 Dual Targeted CAR-T Cell Therapy in R/R B-Cell Acute Lymphoblastic Leukemia

Primary Purpose

CD19+ and CD 22+ B-ALL

Status

Recruiting

Phase

Early Phase 1

Locations

China

Study Type

Interventional

Intervention

Autologous CD19/CD22 Chimeric Antigen Receptor T-cells

Cyclophosphamide,Fludarabine

About this trial

This is an interventional treatment trial for CD19+ and CD 22+ B-ALL focused on measuring CD19, CD22, B-ALL, CAR-T

Eligibility Criteria

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

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Hebei Yanda Ludaopei HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SL19+22 CAR-T

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Efficacy: Remission Rate

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

Secondary Outcome Measures

Efficacy:duration of response (DOR)

Duration of response

Efficacy: progression-free survival (PFS)

progression-free survival (PFS) time

CAR-T proliferation

the copy number of CD19 and CD22 CAR- T cells in the genomes of peripheral blood mononuclear cell (PBMC) by quantitative Real-time PCR (qPCR).

Cytokine release

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

Full Information

NCT ID

NCT05225831

First Posted

January 11, 2022

Last Updated

January 25, 2022

Sponsor

Hebei Senlang Biotechnology Inc., Ltd.

Collaborators

Hebei Yanda Ludaopei Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05225831

Brief Title

Safety and Efficacy of CD19/CD22 Dual Targeted CAR-T Cell Therapy in R/R B-Cell Acute Lymphoblastic Leukemia

Official Title

Safety and Efficacy of CD19/CD22 Dual Targeted CAR-T Cell Therapy in Patients With R/R B-Cell Acute Lymphoblastic Leukemia

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Recruiting

Study Start Date

August 15, 2021 (Actual)

Primary Completion Date

August 2023 (Anticipated)

Study Completion Date

November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hebei Senlang Biotechnology Inc., Ltd.

Collaborators

Hebei Yanda Ludaopei Hospital

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, 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.

Detailed Description

CD19-directed CAR-T cell therapy has shown promising results in the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia. CD19 and CD22 are proteins usually expressed on the surface of the B leukemia cells. The dual-CARs enables the T-cells to recognize and kill the tumor cell through recognition of CD19 and CD22.

6. Conditions and Keywords

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

CD19+ and CD 22+ B-ALL

Keywords

CD19, CD22, B-ALL, CAR-T

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SL19+22 CAR-T

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Autologous CD19/CD22 Chimeric Antigen Receptor T-cells

Other Intervention Name(s)

SL19+22 CAR-T

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Cyclophosphamide,Fludarabine

Intervention Description

Given

Primary Outcome Measure Information:

Title

Safety: Incidence of adverse events

Description

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.

Time Frame

up to 28 days

Title

Efficacy: Remission Rate

Description

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

Time Frame

Up to 3 months

Secondary Outcome Measure Information:

Title

Efficacy:duration of response (DOR)

Description

Duration of response

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 and CD22 CAR- T cells in the genomes of peripheral blood mononuclear cell (PBMC) by quantitative Real-time PCR (qPCR).

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

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: 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. Exclusion Criteria: 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.

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

Beijing Lu Daopei Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hebei Yanda Ludaopei Hospital

City

Langfang

State/Province

Hebei

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Peihua LU, PhD&MD

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy of CD19/CD22 Dual Targeted CAR-T Cell Therapy in R/R B-Cell Acute Lymphoblastic Leukemia

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