Status:
TERMINATED
Targeting CD19/CD20/CD22 Triple-targeted Cell in Patients With Relapsed/Refractory B-cell Lymphoma
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Collaborating Sponsors:
Nanjing Legend Biotech Co.
Conditions:
B-cell Lymphoma Recurrent
B-cell Lymphoma Refractory
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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...
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. S...
Eligibility Criteria
Inclusion
- 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.
- Aged 18-75 years (inclusive).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Histologically confirmed B-cell lymphoma that expresses at least one of CD19/CD20/CD22.
- At least one measurable tumor lesion determined according to Lugano 2014 criteria.
- Response to prior therapy is consistent with one of the following:
- 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;
- 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;
- 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;
- Life expectancy≥ 3 months
- Clinical laboratory values meet screening visit criteria
- Adequate organ function;
Exclusion
- Subject eligible for this study must not meet any of the following criteria:
- Prior antitumor therapy with insufficient washout period ;
- 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;
- With acute or chronic graft-versus-host disease (GvHD);
- 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).
- Known life-threatening allergies, hypersensitivity, or intolerance to LCAR-AIO CAR-T cell or its excipients, including DMSO (refer to Investigator's Brochure).
- Pregnant or lactating women;
Key Trial Info
Start Date :
March 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2025
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT05318963
Start Date
March 14 2022
End Date
March 31 2025
Last Update
June 3 2025
Active Locations (2)
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1
Beijing Gobroad Boren Hospital
Beijing, Beijing Municipality, China
2
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China, 300020