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

Sponsor
Zhejiang University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04788472
Collaborator
Yake Biotechnology Ltd. (Industry)
50
1
1
48
1

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: CAR-T cells targeting CD19 and CD22
Phase 1/Phase 2

Detailed Description

This is a prospective, single arm study. To evaluate the safety and efficacy of sequential CD19 and CD22 CAR-T cells in the treatment of adult newly diagnosed Ph chromosome positive B-cell acute lymphoblastic leukemia. The main endpoints were dose limiting toxicity (DLT) and incidence of adverse events (TEAEs).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical Trial for the Safety and Efficacy of Sequential CD19 and CD22 CAR-T Therapy for Adult Patients With Newly Diagnosed Ph Chromosome Positive B-cell Acute Lymphoblastic Leukemia
Anticipated Study Start Date :
Mar 5, 2021
Anticipated Primary Completion Date :
Mar 5, 2024
Anticipated Study Completion Date :
Mar 5, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: CAR-T therapy

Administration of CD19 and CD22 CAR T-cells

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

Outcome Measures

Primary Outcome Measures

  1. Dose-limiting toxicity (DLT) [Baseline up to 28 days after CAR-T cells infusion]

    Adverse events assessed according to NCI-CTCAE v5.0 criteria

  2. Incidence of treatment-emergent adverse events (TEAEs) [Up to 2 years after CAR-T cells infusion]

    Incidence of treatment-emergent adverse events [Safety and Tolerability]

Secondary Outcome Measures

  1. Complete Remission Rate [up to 28 days after CAR-T cells infusion]

    Complete Remission Rate after CAR-T cell therapy

  2. Overall survival (OS) [Up to 2 years after CD19 CAR-T cells infusion]

    From the first infusion of CD19 CAR-T cells to death or the last visit

  3. Leukemia-free survival (LFS) [Up to 2 years after CD19 CAR-T cells infusion]

    From the complete remission to the occurrence of any event, including death, relapse (any one occurs first), and the last visit

  4. Quality of life [At Baseline, Month 1, 3, 6, 9 and 12]

    Assessment using European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) scale [For item1-28: max score: 112, min score: 28, higher scores mean a better outcome; for item 28-29: max score: 14, min score: 2, higher scores mean a worse outcome] to measure Quality of life at Baseline, Month 1, 3, 6, 9 and 12

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

Ageā‰„15 years old; Newly diagnosed B-cell acute lymphoblastic leukemia according to the 2016 WHO classification; The immunophenotype of leukemia cells were CD19 and CD22 positive; Ph- or Ph- like negative; Anticipated survival time more than 12 weeks; Those who voluntarily participated in this trial and provided informed consent.

Exclusion Criteria:

History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases; Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past; Pregnant (or lactating) women; Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis); Active infection of hepatitis B virus or hepatitis C virus; Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving inhaled steroids; Previously treated with any CAR-T cell product or other genetically-modified T cell therapies; Creatinine>2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin>2.0 mg/dl; Other uncontrolled diseases that were not suitable for this trial; Patients with HIV infection; Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The First Affiliated Hospital, College of Medicine, Zhejiang University Hangzhou Zhejiang China 310003

Sponsors and Collaborators

  • Zhejiang University
  • Yake Biotechnology Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
He Huang, Professor, Zhejiang University
ClinicalTrials.gov Identifier:
NCT04788472
Other Study ID Numbers:
  • CD19-006
First Posted:
Mar 9, 2021
Last Update Posted:
Mar 9, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by He Huang, Professor, Zhejiang University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 9, 2021