A Triple-targeted Cell Preparation Targeting CD19/CD20/CD22 in Patients With Relapsed/Refractory B-cell Acute Lymphocytic Leukemia

NCT05292898 | Terminated Phase 1

• 1 other identifier: IIT2021065
• Study Type: interventional
• Target: 10
• 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 acute lymphocytic leukemia

Conditions

Acute Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (3)

• Incidence, severity, and type of treatment-emergent adverse events (TEAEs)

  An adverse event refers to any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product (investigational or non-investigational), which does not necessarily have a causal relationship with the treatment

  [Time Frame: Minimum 2 years after LCAR-AIO infusion (Day 1)]

• Recommended Phase 2 dose (RP2D) finding

  RP2D established through ATD+BOIN design

  [Time Frame: 30 days after LCAR-AIO infusion (Day 1)]

• CAR positive T cells and CAR transgene levels in peripheral blood and bone marrow

  CAR positive T cells and CAR transgene levels in peripheral blood and bone marrow after LCAR-AIO infusion

  [Time Frame: 2 years after LCAR-AIO infusion (Day 1)]

Secondary Outcomes (6)

• Overall response rate (ORR)

  [Time Frame: 90 days after LCAR-AIO infusion (Day 1)]

• Time to Response (TTR)

  [Time Frame: 90 days after LCAR-AIO infusion (Day 1)]

• Duration of Response (DoR)

  [Time Frame: Minimum 2 years after LCAR-AIO infusion (Day 1)]

• Relapse-free survival (RFS)

  [Time Frame: Minimum 2 years after LCAR-AIO infusion (Day 1)]

• Overall Survival (OS)

  [Time Frame: Minimum 2 years after LCAR-AIO infusion (Day 1)]

Study Arms (1)

LCAR-AIO Cells

EXPERIMENTAL

Each subject will be treated with LCAR-AIO Cells

Biological: LCAR-AIO Cells

Interventions

LCAR-AIO Cells BIOLOGICAL

LCAR-AIO Cells 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

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;
• Age 18-75 years;
• ECOG score: 0-1;
• Detect the expression of at least one of CD19/CD20/CD22 in leukemic cells by Flow cytometry in peripheral blood or bone marrow
• Leukemia cells in the bone marrow \>5%
• Pathologically confirmed relapsed/refractory ALL must meet one of the following conditions:
• Naive patients who failed to achieve CR1 after standard chemotherapy;
• relapse within 12 months after CR1, or relapse after 12 months but fail to achieve CR2
• twice or more bone marrow relapse
• Philadelphia chromosomal positive (Ph+) and unable to tolerate TKI therapy, failed TKI therapy more than 2 lines, or had contraindications for TKI therapy
• Clinical laboratory values meet screening visit criteria
• Expected survival ≥ 3 months;

You may not qualify if:

• Prior antitumor therapy with insufficient washout period; 2.CNS infiltration; Except for patients with prior CNS infiltration who are currently in remission; 3.Have received two or more targets (CD19/CD20/CD22) CAR-T cell therapy (including but not limited to sequential infusion) at any previous time, or have received CAR-T cell therapy from Camel family origin; 4.With acute or chronic graft-versus-host disease; 5.Isolated extramedullary relapse, but hepatic, spleen, or lymph node-isolated extramedullary relapse is acceptable; 6.HBsAg, HBV DNA, HCV-Ab, HCV RNA or HIV-Ab positive; 7.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, China

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

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 14, 2022
• First Posted: March 23, 2022
• Study Start: March 14, 2022
• Primary Completion: January 10, 2025
• Study Completion: March 31, 2025
• Last Updated: June 3, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)