To Observe the Dual-target Chimeric Antigen Receptor T Cells in the Treatment of B Cell Hematologic Tumors

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

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).

Study Overview

• Status: Recruiting
• Conditions: 19 and 22+ B Cell Hematologic Tumors; 19 and 20+ B Cell Hematologic Tumors
• Intervention / Treatment: Biological: Autologous CD19/CD22/CD20 Chimeric Antigen Receptor T-cells

Detailed Description

This study is open single-arm prospective clinical study To relapse/refractory blood B cell tumor patients as the subjects, according to the expression of tumor cells, gives the corresponding double targets CART cell injection treatment, follow-up observation of the adverse reactions and the treatment effect of the drug to the data (at least 2 years), assessment of double targets CAR - T Long-term efficacy and safety of cell injection

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jia Wei, PhD&MD; Phone Number: 008602783665555; Email: jiawei@tjh.tjmu.edu.cn
• Study Contact Backup: Name: Na Kuang, PhD&MD; Phone Number: 008618630160116; Email: kuangna@senlangbio.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China
      • Recruiting
      • Tongji Hospital
      • Contact: Xiaoxi Zhou, PhD&MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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);
2. CD19 positive and CD20 positive or CD22 positive were detected by immunohistochemistry or flow cytometry; 3.18 years old≤age≤70 years old;

4.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.

Exclusion Criteria:

1. 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;
2. Presence of other malignant tumors;
3. There are severe infections that cannot be effectively controlled;
4. 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;
5. Known positive serology for human immunodeficiency virus (HIV) or syphilis;
6. A history of severe allergies to biological products (including antibiotics);
7. Patients with relapses after allogeneic hematopoietic stem cell transplantation with grade 3-4 acute graft-versus-host disease (GvHD);
8. Female patients who are under pregnancy and/or lactation;
9. Active autoimmune disease requiring systemic immunosuppressive therapy;
10. Conditions that the investigator believes may increase the risk to the subject or interfere with the results of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 19+22 CART and 19+20 CART; 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; Single or sequential injection of CD19, CD20 and CD22 CAR T cells.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy: Remission Rate	Remission Rate includes complete remission(CR)、CR with incomplete blood count recovery(CRi)、No remission(NR)	Up to 3 months

Collaborators and Investigators

• Sponsor: Hebei Senlang Biotechnology Inc., Ltd.
• Collaborators: Hebei Taihe Chunyu Biotechnology Co., Ltd
• Investigators: Principal Investigator: Jia Wei, PhD&MD, Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2022
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): May 30, 2027

Study Registration Dates

• First Submitted: May 19, 2022
• First Submitted That Met QC Criteria: May 19, 2022
• First Posted (Actual): May 24, 2022

Study Record Updates

• Last Update Posted (Actual): June 18, 2025
• Last Update Submitted That Met QC Criteria: June 16, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 19+22 for B-ALL/NHL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No