NCT05388695

Brief Summary

To observe the long-term efficacy and safety of dual-target chimeric antigen receptor T cells in the treatment of refractory relapsed B cell hematologic tumors (at least 2 years).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
13mo left

Started Apr 2022

Longer than P75 for 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 Progress79%
Apr 2022May 2027

Study Start

First participant enrolled

April 8, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 19, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 24, 2022

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2027

Last Updated

June 18, 2025

Status Verified

June 1, 2025

Enrollment Period

5 years

First QC Date

May 19, 2022

Last Update Submit

June 16, 2025

Conditions

19 and 22+ B Cell Hematologic Tumors19 and 20+ B Cell Hematologic Tumors

Outcome Measures

Primary Outcomes (1)

  • Efficacy: Remission Rate

    Remission Rate includes complete remission(CR)、CR with incomplete blood count recovery(CRi)、No remission(NR)

    Up to 3 months

Study Arms (1)

19+22 CART and 19+20 CART

EXPERIMENTAL

Eligible patients will be treated with 19+22 CAR-T and 19+20 CAR-T.

Biological: Autologous CD19/CD22/CD20 Chimeric Antigen Receptor T-cells

Interventions

Autologous CD19/CD22/CD20 Chimeric Antigen Receptor T-cellsBIOLOGICAL

Single or sequential injection of CD19, CD20 and CD22 CAR T cells.

19+22 CART and 19+20 CART

Eligibility Criteria

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

You may qualify if:

  • Refractory and relapsed B-cell tumor determined by clinical diagnosis, B cell tumors include the following three categories: B cell acute lymphocyte leucocyte; Inert B cell lymphoma (CLL、 FL、 MZL); Aggressive B-cell lymphoma (DLBCL、 BL、 MCL);
  • CD19 positive and CD20 positive or CD22 positive were detected by immunohistochemistry or flow cytometry; 3.18 years old≤age≤70 years old;
  • Estimated survival time\>3 months; 5.ECOG Scores: 0\~2; 6.There should be at least one measurable tumor foci according to RECIST Version 1.1; 7.The functions of vital organs must meet the following conditions: EF\>50%, and no obvious abnormality of electrocardiogram; SpO2≥92%; Cr≤1.5ULN; ALTand AST≤5ULN, TBil≤3ULN; 8.Subjects planning to become pregnant must agree to use contraception prior to enrolling in the study and after six months of study duration; inform the investigator immediately if the subject becomes pregnant or suspects pregnancy; 9.The subject or guardian understands and signs the informed consent.

You may not qualify if:

  • With other diseases that are not effectively controlled, including, but not limited to, persistent or poorly controlled infections symptomatic congestive heart failure unstable angina arrhythmia poorly controlled pulmonary disease or psychiatric disease;
  • Presence of other malignant tumors;
  • There are severe infections that cannot be effectively controlled;
  • Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive, peripheral blood hepatitis B virus (HBV)DNA higher than the detection limit should be excluded; If hepatitis C virus (HCV) antibody positive, peripheral blood HCV RNA positive need to exclude; Cytomegalovirus (CMV)DNA positive; Epstein-barr virus DNA positive in peripheral blood;
  • Known positive serology for human immunodeficiency virus (HIV) or syphilis;
  • A history of severe allergies to biological products (including antibiotics);
  • Patients with relapses after allogeneic hematopoietic stem cell transplantation with grade 3-4 acute graft-versus-host disease (GvHD);
  • Female patients who are under pregnancy and/or lactation;
  • Active autoimmune disease requiring systemic immunosuppressive therapy;
  • Conditions that the investigator believes may increase the risk to the subject or interfere with the results of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, China

RECRUITING

Related Publications (1)

  • He S, Peng J, Yang X, Meng F, Huang L, Huang L, Tian W, Gao Z, Zhao J, Wang Z, Wei J. Peripheral Blood Smears Distinguish Infective Fever after CAR-T Therapy. Front Biosci (Landmark Ed). 2023 Nov 24;28(11):299. doi: 10.31083/j.fbl2811299.

    PMID: 38062808DERIVED

Study Officials

  • Jia Wei, PhD&MD

    Tongji Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jia Wei, PhD&MD

CONTACT

008602783665555jiawei@tjh.tjmu.edu.cn

Na Kuang, PhD&MD

CONTACT

008618630160116kuangna@senlangbio.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2022

First Posted

May 24, 2022

Study Start

April 8, 2022

Primary Completion (Estimated)

March 30, 2027

Study Completion (Estimated)

May 30, 2027

Last Updated

June 18, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)