NCT05744037

Brief Summary

To evaluate the ORR (CR+PR) of R/R B-NHL subjects treated with BTKi+Anti-CD19 CAR T cells.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 14, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 24, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

February 24, 2023

Status Verified

February 1, 2023

Enrollment Period

2 years

First QC Date

February 14, 2023

Last Update Submit

February 23, 2023

Conditions

B-cell Non Hodgkin Lymphoma

Keywords

BTK inhibitorAnti CD19 CAR-T cells

Outcome Measures

Primary Outcomes (1)

  • objective response rate

    CR+PR

    From 1 month to 1 year.

Secondary Outcomes (3)

  • Percentage of complete response

    From 1 month to 1 year.

  • Progression-free survival

    From 1 month to 1 year.

  • Duration of response

    From 1 month to 1 year.

Study Arms (1)

CAR-T Cell Infusion

EXPERIMENTAL

After FC regimen (fludarabine (25mg/m2/d) on days -5 to -3 and cyclophosphamide (750mg/m2) on days -5) were pretreated, Anti-CD19 CAR T cells were transfused on day 0. The dose was determined by the investigator according to the subjects' own disease conditions and in vitro preparation. Intravenous drip/push at a constant rate for 30 minutes; Ibrutinib, a BTK inhibitor, was enrolled with a standard dose of 560mg qd.

Biological: regimen with BTK inhibitor +Anti-CD19 CAR T cells

Interventions

regimen with BTK inhibitor +Anti-CD19 CAR T cellsBIOLOGICAL

After FC regimen (fludarabine (25mg/m2/d) on days -5 to -3 and cyclophosphamide (750mg/m2) on days -5) were pretreated, Anti-CD19 CAR T cells were transfused on day 0. The dose was determined by the investigator according to the subjects' own disease conditions and in vitro preparation. Intravenous drip/push at a constant rate for 30 minutes; Ibrutinib, a BTK inhibitor, was enrolled with a standard dose of 560mg qd.

CAR-T Cell Infusion

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients or their legal guardians voluntarily participate and sign the informed consent;
  • Male or female patients aged 18-70 years old;
  • CD19+ B-NHL was confirmed by pathology and histology, and the patient had no effective treatment options at present, such as chemotherapy or hematopoietic stem cell transplantation after recurrence; Or patients voluntarily chose BTKi+Anti-CD19 CAR T as salvage therapy;
  • Subjects showed residual lesions after major treatment and were not suitable for HSCT; Relapse occurs after CR and is not suitable for HSCT; Patients with high risk factors; Relapse or no remission after hematopoietic stem cell transplantation or cellular immunotherapy;
  • Have measurable or evaluable lesions;
  • The patient's main tissues and organs function well;
  • The patient's peripheral shallow venous blood flow is smooth, which can meet the needs of intravenous drip.
  • Patients with ECOG score ≤2, estimated survival time ≥3 months, age ≥ 12 years, ≤ 75 years.

You may not qualify if:

  • Women who are pregnant (urine/blood pregnancy test is positive) or breastfeeding;
  • Men or women who have planned to get pregnant within the last 1 year;
  • The patients were not guaranteed to take effective contraceptive measures (condom or contraceptive, etc.) within 1 year after enrollment;
  • Patients had uncontrollable infectious diseases within 4 weeks prior to enrollment;
  • Active hepatitis B/C virus;
  • HIV-infected patients;
  • Suffering from a serious autoimmune disease or immunodeficiency disease;
  • The patient is allergic to antibodies, cytokines and other macromolecular biological drugs;
  • The patient had participated in other clinical trials within 6 weeks prior to enrollment;
  • Systemic use of hormones within 4 weeks prior to enrollment (except for inhaled hormones);
  • Suffering from mental illness;
  • The patient has substance abuse/addiction;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221002, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell

Interventions

Clinical Protocols

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsEpidemiologic Study CharacteristicsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and Evaluation

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

February 14, 2023

First Posted

February 24, 2023

Study Start

January 1, 2023

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

February 24, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)