A Phase 1 interventional study of LCAR-AIO cells product in B-cell Lymphoma Recurrent and B-cell Lymphoma Refractory, sponsored by Institute of Hematology & Blood Diseases Hospital, China. Terminated at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-06-03.
Sponsored by Institute of Hematology & Blood Diseases Hospital, China · Phase 1, Interventional, and Treatment
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.
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 14 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Institute of Hematology & Blood Diseases Hospital, China is the lead sponsor of 398 studies on the registry; 293 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Response to prior therapy is consistent with one of the following:
Exclusion Criteria:
Subject eligible for this study must not meet any of the following criteria:
Each subject will be given a single-dose LCAR-AIO cells infusion at each dose level.
Biological: 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.
Incidence, severity and type of TEAEs (Treatment-emergent Adverse Events)
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Time frame: Minimum 2 years after LCAR-AIO infusion (Day 1)
Pharmacokinetics in peripheral blood
CAR positive T cells and CAR transgene levels in peripheral blood after LCAR-AIO infusion.
Time frame: Minimum 2 years after LCAR-AIO infusion (Day 1)
Pharmacokinetics in bone marrow
CAR positive T cells and CAR transgene levels in bone marrow after LCAR-AIO infusion.
Time frame: Minimum 2 years after LCAR-AIO infusion (Day 1)
The recommended Phase II dose (RP2D) for this cell therapy
RP2D established through ATD+BOIN design and the DLTs occurring following CAR T-cell infusion
Time frame: 30 days after LCAR-AIO infusion
Overall Response Rate (ORR)
Objective Response Rate (ORR) is defined as the proportion of subjects who achieve CR or PR after treatment via LCAR-AIO cell infusion
Time frame: Through study completion, minimum 2 years after LCAR-AIO infusion (Day 1)
Progression-free survival (PFS)
Progression Free Survival (PFS) is defined as the time from the date of first infusion of the LCAR-AIO to the first documented disease progression (according to Lugano 2014) or death (due to any cause), whichever occurs first
Time frame: Through study completion, minimum 2 years after LCAR-AIO infusion (Day 1)
Overall Survival (OS)
Overall Survival (OS) is defined as the time from the date of first infusion of LCAR-AIO to death of the subject
Time frame: Through study completion, minimum 2 years after LCAR-AIO infusion (Day 1)
Time to Response (TTR)
Time to Response (TTR) is defined as the time from the date of first infusion of LCAR-AIO to the date of the first response evaluation of the subject who has met all criteria for CR or PR.
Time frame: Through study completion, minimum 2 years after LCAR-AIO infusion (Day 1)
Duration of Response (DoR)
Duration of Remission (DoR) is defined as the time from the first documentation of remission (CR or PR) to the first documented relapse evidence of the responders
Time frame: Through study completion, minimum 2 years after LCAR-AIO infusion (Day 1)
Immunogenicity assessment of LCAR-AIO cells
The incidence of Anti-LCAR-AIO antibody in patients who received LCAR-AIO cells infusion
Time frame: Through study completion, minimum 2 years after LCAR-AIO infusion (Day 1)
Plan to share: No
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This study is terminated, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Institute of Hematology & Blood Diseases Hospital, China