NCT03125577

Brief Summary

The study will evaluate safety and efficacy of a combination of 4th generation chimeric antigen receptor gene-modified T cells targeting CD19 (4SCAR19) and CD20 (4SCAR20), CD22 (4SCAR22), CD30 (4SCAR30), CD38 (4SCAR38), CD70 (4SCAR70) or CD123 (4SCAR123) for patients with B cell malignancies. Clinical response and development of a standardized lentiviral vector and cell production protocol will be investigated. This is a phase I/II trial enrolling patients from multiple clinical centers.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

April 19, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 24, 2017

Completed
8.3 years until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Completed
Last Updated

August 24, 2026

Status Verified

August 1, 2026

Enrollment Period

11 months

First QC Date

April 19, 2017

Last Update Submit

August 21, 2026

Conditions

B-cell Malignancies

Keywords

4S CAR-TCD19CD20CD22CD38CD123B cell leukemiaB-ALLCD70CD30

Outcome Measures

Primary Outcomes (1)

  • Safety of fourth generation anti CD19 and CD20/CD22/CD30/CD38/CD70/CD123 CAR-T cells in patients with relapsed B cell malignancies using CTCAE 4 standard to evaluate the level of adverse events standard to evaluate the level of adverse events

    physiological parameter (for safety, measuring cytokine response, fever, symptoms)

    24 weeks

Secondary Outcomes (1)

  • Anti tumor activity of fourth generation anti CD19 and CD20/CD22/CD30/CD38/CD70/CD123 CAR-T cells in patients with relapsed or refractory B cell malignancies

    1 year

Study Arms (1)

4SCAR19 and 4SCAR20/CD22/CD30/CD38/CD70/CD123

EXPERIMENTAL

Patients who have relapsed and refractory B cell malignancies after chemotherapy will be treated with CD19 and CD20/CD22/CD30/CD38/CD70/CD123-specific gene-engineered T cells.

Biological: 4SCAR19 and 4SCAR22Biological: 4SCAR19 and 4SCAR38Biological: 4SCAR19 and 4SCAR20Biological: 4SCAR19 and 4SCAR123Biological: 4SCAR19 and 4SCAR70Biological: 4SCAR19 and 4SCAR30

Interventions

4SCAR19 and 4SCAR22BIOLOGICAL

4SCAR19 and 4SCAR22

4SCAR19 and 4SCAR20/CD22/CD30/CD38/CD70/CD123
4SCAR19 and 4SCAR38BIOLOGICAL

4SCAR19 and 4SCAR38

4SCAR19 and 4SCAR20/CD22/CD30/CD38/CD70/CD123
4SCAR19 and 4SCAR20BIOLOGICAL

4SCAR19 and 4SCAR20

4SCAR19 and 4SCAR20/CD22/CD30/CD38/CD70/CD123
4SCAR19 and 4SCAR123BIOLOGICAL

4SCAR19 and 4SCAR123

4SCAR19 and 4SCAR20/CD22/CD30/CD38/CD70/CD123
4SCAR19 and 4SCAR70BIOLOGICAL

4SCAR19 and 4SCAR70

4SCAR19 and 4SCAR20/CD22/CD30/CD38/CD70/CD123
4SCAR19 and 4SCAR30BIOLOGICAL

4SCAR19 and 4SCAR30

4SCAR19 and 4SCAR20/CD22/CD30/CD38/CD70/CD123

Eligibility Criteria

Age6 Months - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • age older than 6 months.
  • malignant B cell surface expression of CD19/CD20/CD22/CD30/CD38/CD70/CD123 molecules.
  • the KPS score over 80 points, and survival time is more than 1 month.
  • greater than Hgb 80 g/L.
  • no contraindications to blood cell collection.

You may not qualify if:

  • accompanied with other active diseases, the treatment is difficult to assess patient response.
  • bacteria, fungus, or virus infection, unable to control.
  • living with HIV.
  • active HBV and HCV infection.
  • pregnant and nursing mothers.
  • under systemic steroid treatment within a week of the treatment.
  • prior failed CAR-T treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shenzhen Geno-immune Medical Institute

Shenzhen, Guangdong, 518000, China

Location

Related Publications (1)

  • Nair S, Wang JB, Tsao ST, Liu Y, Zhu W, Slayton WB, Moreb JS, Dong L, Chang LJ. Functional Improvement of Chimeric Antigen Receptor Through Intrinsic Interleukin-15Ralpha Signaling. Curr Gene Ther. 2019;19(1):40-53. doi: 10.2174/1566523218666181116093857.

    PMID: 30444200DERIVED

MeSH Terms

Conditions

Leukemia, B-Cell

Condition Hierarchy (Ancestors)

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

Study Officials

  • Lung-Ji Chang, PhD

    Shenzhen Geno-Immune Medical Institute

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 19, 2017

First Posted

April 24, 2017

Study Start

August 1, 2025

Primary Completion

July 1, 2026

Study Completion

July 31, 2026

Last Updated

August 24, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)