NCT04532268

Brief Summary

A Study of Humanized CD19 CAR-T Cells Therapy for Patients With Relapsed and/or Refractory B-cell Acute Lymphoblastic Leukemia and B-cell Non-Hodgkin's Lymphoma.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for early_phase_1

Timeline
4mo left

Started Aug 2020

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Aug 2020Aug 2026

First Submitted

Initial submission to the registry

August 20, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

August 23, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 31, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2023

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2026

Expected
Last Updated

August 31, 2020

Status Verified

August 1, 2020

Enrollment Period

3 years

First QC Date

August 20, 2020

Last Update Submit

August 25, 2020

Conditions

Acute Lymphoblastic LeukemiaNon-hodgkin Lymphoma,B Cell

Keywords

Acute Lymphoblastic LeukemiaNon-Hodgkin's LymphomaCAR T-cell therapy

Outcome Measures

Primary Outcomes (2)

  • Dose-limiting toxicity (DLT)

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

    Baseline up to 28 days after humanized CD19 targeted CAR T-cells infusion

  • Incidence of treatment-emergent adverse events (TEAEs)

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

    Up to 2 years after humanized CD19 targeted CAR T-cells infusion

Secondary Outcomes (9)

  • B-cell acute lymphocytic leukemia(B-ALL), Overall response rate (ORR)

    At Month 1, 3, 6, 12, 18 and 24

  • B-ALL, Overall survival (OS)

    Up to 2 years after humanized CD19 CAR-T cells infusion

  • B-ALL, Event-free survival (EFS)

    Up to 2 years after humanized CD19 CAR-T cells infusion

  • B cell non-hodgkin's lymphoma (B-NHL), Overall response rate (ORR)

    At Week 4, 12, and Month 6, 12, 18, 24

  • B-NHL, disease control rate (DCR)

    At Week 12 and Month 6, 12, 18, 24

  • +4 more secondary outcomes

Study Arms (1)

Administration of Humanized CD19 CAR T-cells

EXPERIMENTAL

Dose escalation follows the standard 3+3 dose escalation design. A total of 3 dose levels are set for subjects.

Drug: Humanized CD19 CAR-T cells

Interventions

Humanized CD19 CAR-T cellsDRUG

Each subject receive humanized CD19 CAR T-cells by intravenous infusion

Also known as: Humanized CD19 CAR-T cells injection
Administration of Humanized CD19 CAR T-cells

Eligibility Criteria

Age3 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female aged 3-70 years;
  • Histologically confirmed diagnosis of CD19+ B-ALL per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphoblastic Leukemia (2016.v1);
  • Relapsed or refractory CD19+ B-ALL (meeting one of the following conditions):
  • CR not achieved after standardized chemotherapy;
  • CR achieved following the first induction, but CR duration is less than 12 months;
  • Ineffectively after first or multiple remedial treatments;
  • or more relapses;
  • The number of primordial cells (lymphoblast and prolymphocyte) in bone marrow is \>5% (by morphology), and/or \>1% (by flow cytometry);
  • Philadelphia-chromosome-negative (Ph-) patients; or Philadelphia-chromosome-positive (Ph+) patients who cannot tolerate TKI treatments or do not respond to 2 TKI treatments;
  • Male or female aged 18-75 years;
  • Histologically confirmed diagnosis of DLBCL (NOS), FL, DLBCL transformed from CLL/SLL, PMBCL, and HGBCL per the WHO Classification Criteria for Lymphoma (2016);
  • Relapsed or refractory B-NHL (meeting one of the following conditions):
  • No response or relapse after second-line or above chemotherapy regimens;
  • Primary drug resistance;
  • Relapse after auto-HSCT;
  • +7 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital，College of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

RECRUITING

Related Publications (2)

  • Zhou L, Fu W, Wu S, Xu K, Qiu L, Xu Y, Yan X, Zhang Q, Zhang M, Wang L, Hong R, Chang AH, Yu J, Fu S, Kong D, Li L, Wang Y, Li Z, Jiang H, Huang J, Liu Z, Su N, Wei G, Hu Y, Huang H. Derivation and validation of a novel score for early prediction of severe CRS after CAR-T therapy in haematological malignancy patients: A multi-centre study. Br J Haematol. 2023 Aug;202(3):517-524. doi: 10.1111/bjh.18873. Epub 2023 May 16.

    PMID: 37192741DERIVED

  • Song F, Hu Y, Zhang Y, Zhang M, Yang T, Wu W, Huang S, Xu H, Chang AH, Huang H, Wei G. Safety and efficacy of autologous and allogeneic humanized CD19-targeted CAR-T cell therapy for patients with relapsed/refractory B-ALL. J Immunother Cancer. 2023 Feb;11(2):e005701. doi: 10.1136/jitc-2022-005701.

    PMID: 36808074DERIVED

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma

Central Study Contacts

He Huang, PhD

CONTACT

86-13605714822hehuangyu@126.com

Yongxian Hu, PhD

CONTACT

86-15957162012huyongxian2000@aliyun.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

August 20, 2020

First Posted

August 31, 2020

Study Start

August 23, 2020

Primary Completion

August 23, 2023

Study Completion (Estimated)

August 23, 2026

Last Updated

August 31, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)