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

NCT ID: NCT05225831

Last Updated: 2022-02-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-15
• Study Completion Date: 2023-11-30

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.

Conditions

CD19+ and CD 22+ B-ALL

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SL19+22 CAR-T

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

Group Type: EXPERIMENTAL

Autologous CD19/CD22 Chimeric Antigen Receptor T-cells

Intervention Type: BIOLOGICAL

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

Cyclophosphamide,Fludarabine

Intervention Type: DRUG

Given

Interventions

Autologous CD19/CD22 Chimeric Antigen Receptor T-cells

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

Intervention Type: BIOLOGICAL

Cyclophosphamide,Fludarabine

Given

Intervention Type: DRUG

Other Intervention Names

SL19+22 CAR-T

Eligibility Criteria

Inclusion Criteria

1. 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;

2. 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;

3. ECOG Scores: 0~2

4. CD19 positive and CD22 positive were detected by immunohistochemistry or flow cytometry;

5. Estimated survival time>3 months;

6. Peripheral blood mononuclear immune cells must be collected at least 2 weeks after the last radiotherapy or systemic treatment.

7. For patients with only extramedullary recurrence of B-ALL, there must be at least one assessable lesion.

Exclusion Criteria

1. Serious cardiac insufficiency；

2. Has a history of severe pulmonary function damaging;

3. Presence of other malignant tumors.

4. Presence of active fungal, bacterial, viral, or other infection requiring IV antibiotics for management.

5. Presence of other severe autoimmune diseases or immunodeficiency disease;

6. Patients with active hepatitis B or hepatitis C([HBVDNA+]or [HCVRNA+]);

7. Known positive serology for human immunodeficiency virus (HIV) or syphilis。

8. Has a history of serious allergies on biological products (including antibiotics);

9. Female patients who are under pregnancy and/or lactation, or planing on pregnancy for the next 12 months.

10. Any other situations that the researchers believe will affect the results of the study.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hebei Yanda Ludaopei Hospital

OTHER

Sponsor Role: collaborator

Hebei Senlang Biotechnology Inc., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peihua Lu, PhD&MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Lu Daopei Hospital

Locations

Hebei Yanda Ludaopei Hospital

Langfang, Hebei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Peihua Lu, PhD&MD

Role: CONTACT

peihua_lu@126.com

008618611636172

Jianqiang Li, PhD&MD

Role: CONTACT

limmune@gmail.com

008615511369555

Facility Contacts

Peihua LU, PhD&MD

Role: primary

Other Identifiers

SL19+22 for B-ALL

Identifier Type: -

Identifier Source: org_study_id