NCT04605666

Brief Summary

Chimeric antigen receptor T cells (CAR-T cells) has been recognized a promising treatment option for treating B cell derived malignancy. The purpose of this study is to evaluate the efficacy and safety of third-generation anti-CD19 CAR T-cells (CD19-CAR-T2 Cells) in patients with CD19+ relapsed or refractory (r/r) B-cell acute lymphoblastic leukemia (B-ALL) and B-cell Non Hodgkin Lymphoma (B-NHL).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2020

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

May 1, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 28, 2020

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

August 20, 2024

Status Verified

August 1, 2024

Enrollment Period

3.2 years

First QC Date

October 25, 2020

Last Update Submit

August 18, 2024

Conditions

B Cell LeukemiaB Cell Lymphoma

Keywords

CAR-T

Outcome Measures

Primary Outcomes (1)

  • ORR

    Overall Response Rate includes Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi), as determined by assessments of peripheral blood, bone marrow, CNS symptoms, physical exam (PE) and CSF. The primary endpoint will be based on the IRC assessment. The local investigator's assessed results will be used for sensitivity analysis.

    3 months

Secondary Outcomes (5)

  • ORR

    6 months

  • ORR

    12 months

  • Adverse Events

    12 months

  • OS

    1 year

  • DFS

    1 year

Study Arms (1)

CAR-T group

EXPERIMENTAL
Biological: CD19-CAR-T2 Cells

Interventions

CD19-CAR-T2 CellsBIOLOGICAL

CD19-CAR-T2 T cells will be infused over 10-15 minutes on Day 0.

CAR-T group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with relapsed and/or refractory CD19+ B-cell leukemia or lymphoma
  • Eastern Cooperative Oncology Group (ECOG) performance status \<2
  • ALT/ AST \<3 x normal
  • Bilirubin \< 2.0 mg/dl
  • Creatinine \< 2.5 mg/dl and less than 2.5x normal for age
  • LVEF\< 45%
  • Accept white blood cell collection
  • Provide informed consent

You may not qualify if:

  • Previous treatment with investigational gene or cell therapy medicine products
  • Active hepatitis B , hepatitis C or HIV infection
  • Uncontrolled active infection
  • Presence of grade 2-4 acute or extensive chronic GVHD
  • Any uncontrolled active medical disorder that would preclude participation as outlined.
  • Received non-diagnostic purposes major surgery within the past 4 weeks
  • Participated in any other clinical study within the past 4 weeks
  • Used murine biological products (except blinatumomab), unless it is proved no anti-mouse antibodies exist.
  • Pregnancy or breast-feeding women
  • Use of prohibited drugs:
  • Steroids: Therapeutic doses of steroids must be stopped \> 72 hours prior to CD19-CAR-T2 Cells infusion
  • Allogeneic cellular therapy: Any donor lymphocyte infusions (DLI) must be completed \> 4 weeks prior to CD19-CAR-T2 Cells infusion
  • GVHD therapies: Any drug used for GVHD must be stopped \> 4 weeks prior to CD19-CAR-T2 Cells infusion
  • Any situation that may increase the risk of the test or interfere with the test results

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

Related Publications (1)

  • He B, Lin R, Xu N, Qin L, Wang Z, Wang Q, Li X, Wei X, Wei Y, Tang Z, Fan Z, Huang F, Liu X, Sun J, Xuan L, Li P, Zhou H, Liu Q. Efficacy and safety of third-generation CD19-CAR T cells incorporating CD28 and TLR2 intracellular domains for B-cell malignancies with central nervous system involvement: results of a pivotal trial. J Transl Med. 2025 May 27;23(1):594. doi: 10.1186/s12967-025-06608-x.

    PMID: 40426201DERIVED

MeSH Terms

Conditions

Leukemia, B-CellLymphoma, B-Cell

Condition Hierarchy (Ancestors)

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

Study Officials

  • Qi-fa Liu, MD

    Nanfang Hospital, Southern Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2020

First Posted

October 28, 2020

Study Start

May 1, 2020

Primary Completion

June 30, 2023

Study Completion

December 31, 2023

Last Updated

August 20, 2024

Record last verified: 2024-08

Locations

CN(1)