Sequential CD19 and CD22 CAR-T Therapy for Newly Diagnosed Ph+ B-ALL

NCT04788472 | Completed Phase 2 DMC

• 1 other identifier: CD19-006
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical Trial for the Efficacy and Safety of Sequential CD19 and CD22 CAR-T Therapy for Adult Patients With Newly Diagnosed Ph Chromosome Positive B-cell Acute Lymphoblastic Leukemia

Conditions

B-Cell Acute Lymphoblastic Leukemia, Adult

Keywords

CD19 CAR-T; CD22 CAR-T; Ph Chromosome Positive; B-ALL; Newly diagnosed

Outcome Measures

Primary Outcomes (1)

• Complete molecular response (CMR) rate

  Complete molecular response (CMR) rate after CD19 CAR-T cell therapy

  Up to 1 month after CAR-T cells infusion

Secondary Outcomes (6)

• Complete molecular response (CMR) rate

  Up to 1 month after CAR-T cells infusion

• Leukemia-free survival (LFS)

  Up to 2 years after CD19 CAR-T cells infusion

• Overall survival (OS)

  Up to 2 years after CD19 CAR-T cells infusion

• cumulative incidence of relapse (CIR)

  Up to 2 years after CD19 CAR-T cells infusion

• Incidence of treatment-emergent adverse events (TEAEs)

  Through study completion, an average of 2 years

Study Arms (1)

CAR-T therapy

EXPERIMENTAL

Administration of CD19 and CD22 CAR T-cells

Drug: CAR-T cells targeting CD19 and CD22

Interventions

CAR-T cells targeting CD19 and CD22 DRUG

Each subject receives sequential CD19 and CD22 CAR-T cells by intravenous infusion

CAR-T therapy

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years old;
• Subjects with a diagnosis of B-cell acute lymphoblastic leukemia according to the 2016 edition of the WHO classification criteria for acute leukemia;
• Subjects whose chromosomal and fusion gene analysis showed positivity for the Ph chromosome, BCR/ABL1 fusion gene;
• Leukemia cells were CD19 and CD22 positive;
• Patients with newly diagnosed B-ALL were not treated with standard chemotherapy regimens;
• Serum total bilirubin ≤ 51 mol/L, serum ALT and AST both ≤ 3 times the upper limit of the normal range, blood creatinine ≤ 176.8 mol/L;
• Echocardiography showed a left ventricular ejection fraction (LVEF) ≥50%;
• Subjects had no active pulmonary infection and oxygen saturation ≥92% without oxygen;
• The prognosis for survival is more than 3 months;
• ECOG score 0-2;
• Subjects volunteered to participate in this trial and signed an informed consent form.

You may not qualify if:

• Those with a history of epilepsy or other central nervous system disorders;
• Those with a history of prolonged QT period or severe cardiac disease;
• Women who are pregnant or breastfeeding (the safety of this therapy for the unborn child is not known);
• Those with uncontrolled active infection;
• Active hepatitis B or hepatitis C virus infection;
• Those who have previously used any gene therapy product;
• Those with insufficient amplification (\<5-fold) in response to CD3/CD28 co-stimulatory signals;
• Creatinine \> 2.5 mg/dl or ALT / AST \> 3 times the upper limit of the normal range or bilirubin \> 2.0 mg/dl;
• Those who suffer from other uncontrolled medical conditions that, in the opinion of the investigator, make them unsuitable for enrollment;
• HIV-infected persons;
• Any condition that, in the opinion of the investigator, may increase the risk to the subject or interfere with the results of the test.

Sponsors & Collaborators

• Zhejiang University: lead
• Yake Biotechnology Ltd.: collaborator

Study Sites (1)

The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

Related Publications (1)

• Zhang M, Fu S, Feng J, Hong R, Wei G, Zhao H, Zhao M, Xu H, Cui J, Huang S, Wu X, Liu L, Sun J, Wu W, Zhu Y, He J, Zhao Y, Cai Z, Zheng W, Ye X, Shi J, Luo Y, Wang D, Chang AH, Hu Y, Huang H. Dasatinib and CAR T-Cell Therapy in Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia: A Nonrandomized Clinical Trial. JAMA Oncol. 2025 Jun 1;11(6):625-629. doi: 10.1001/jamaoncol.2025.0674.

  PMID: 40244598 DERIVED

MeSH Terms

Conditions

Burkitt Lymphoma

Condition Hierarchy (Ancestors)

Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 5, 2021
• First Posted: March 9, 2021
• Study Start: March 5, 2021
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: October 17, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)