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

NCT05318963 | Terminated Phase 1

• 1 other identifier: IIT2021066
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

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.

Conditions

B-cell Lymphoma Recurrent; B-cell Lymphoma Refractory

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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

  30 days after LCAR-AIO infusion

Secondary Outcomes (6)

• Overall Response Rate (ORR)

  Through study completion, minimum 2 years after LCAR-AIO infusion (Day 1)

• Progression-free survival (PFS)

  Through study completion, minimum 2 years after LCAR-AIO infusion (Day 1)

• Overall Survival (OS)

  Through study completion, minimum 2 years after LCAR-AIO infusion (Day 1)

• Time to Response (TTR)

  Through study completion, minimum 2 years after LCAR-AIO infusion (Day 1)

• Duration of Response (DoR)

  Through study completion, minimum 2 years after LCAR-AIO infusion (Day 1)

Study Arms (1)

LCAR-AIO cells product

EXPERIMENTAL

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

Biological: LCAR-AIO cells product

Interventions

LCAR-AIO cells product 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.

LCAR-AIO cells product

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead
• Nanjing Legend Biotech Co.: collaborator

Study Sites (2)

Beijing Gobroad Boren Hospital

Beijing, Beijing Municipality, China

Location

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, 300020, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: April 8, 2022
• Study Start: March 14, 2022
• Primary Completion: January 17, 2025
• Study Completion: March 31, 2025
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)