Targeting CD19/CD20/CD22 Triple-targeted Cell in Patients With Relapsed/Refractory B-cell Lymphoma

NCT ID: NCT05318963

Last Updated: 2025-06-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-14
• Study Completion Date: 2025-03-31

Brief Summary

A phase I, open-label clinical study to evaluate the safety, tolerability, and efficacy of LCAR-AIO, a triple-targeted cell preparation targeting CD19/CD20/CD22, in patients with relapsed/refractory B-cell lymphoma.

Detailed Description

This is an open-label, dose-escalation/dose extension study to assess the safety, tolerability, and efficacy of LCAR-AIO in the patient ≥ 18 years of age with relapsed or refractory B cell lymphoma. Subjects who meet the eligibility criteria will receive a single dose of LCAR-AIO injection. The study will include the following sequential phases: screening, pre-treatment (cell product preparation; lymphodepleting chemotherapy), treatment, and follow-up.

Conditions

B-cell Lymphoma Recurrent; B-cell Lymphoma Refractory

Study Design

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

Study Groups

LCAR-AIO cells product

Each subject will be given a single-dose LCAR-AIO cells infusion at each dose level.

Group Type: EXPERIMENTAL

LCAR-AIO cells product

Intervention Type: BIOLOGICAL

before treatment with LCAR-AIO cells, subjects will receive a conditioning regimen (IV infusion of cyclophosphamide 300 mg/m\^2 and fludarabine 30mg/m\^2 once daily (QD) for 3 days.

Interventions

LCAR-AIO cells product

before treatment with LCAR-AIO cells, subjects will receive a conditioning regimen (IV infusion of cyclophosphamide 300 mg/m\^2 and fludarabine 30mg/m\^2 once daily (QD) for 3 days.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Subjects have fully understood the possible risks and benefits of participating in this study, are willing to follow and able to complete all trial procedures, and have signed informed consent.

2. Aged 18-75 years (inclusive).

3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

4. Histologically confirmed B-cell lymphoma that expresses at least one of CD19/CD20/CD22.

5. At least one measurable tumor lesion determined according to Lugano 2014 criteria.

6. Response to prior therapy is consistent with one of the following:

1. Primary refractory: it means that the best response to first-line therapy (at least 2 cycles) is PD, or best response to first-line therapy (at least 4 cycles) is SD but the duration is less than 6 months, which is considered to be PD;

2. Relapsed or refractory after 2 or more lines of therapy. Refractory is defined that best respond to the most recent treatment regimen (at least 2 cycles) is PD, or best response to the most recent treatment regimen (at least 4 cycles) is SD but the duration is less than 6 months, which is considered to be PD;

3. Progression or relapse within 12 months after hematopoietic stem cell transplantation; if salvage therapy is applied after transplantation, the patient must be unresponsive or relapsed to the last line of therapy;

7. Life expectancy≥ 3 months

8. Clinical laboratory values meet screening visit criteria

9. Adequate organ function;

Exclusion Criteria

Subject eligible for this study must not meet any of the following criteria:

1. Prior antitumor therapy with insufficient washout period ;

2. Patients who received dual-targeted CAR-T cell therapy (including but not limited to sequential infusion) at any time in the past, or who received CAR-T cell therapy of cameloid origin;

3. With acute or chronic graft-versus-host disease (GvHD);

4. Patients who are positive for any index of hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C antibody (HCV-Ab), hepatitis C virus ribonucleic acid (HCV RNA), or human immunodeficiency virus antibody (HIV- Ab).

5. Known life-threatening allergies, hypersensitivity, or intolerance to LCAR-AIO CAR-T cell or its excipients, including DMSO (refer to Investigator's Brochure).

6. Pregnant or lactating women;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing Legend Biotech Co.

INDUSTRY

Sponsor Role: collaborator

Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Gobroad Boren Hospital

Beijing, Beijing Municipality, China

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, China

Countries

China

Other Identifiers

IIT2021066

Identifier Type: -

Identifier Source: org_study_id