Using dual-target CAR T cells to treat B cell blood cancers

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

This study is testing a new type of CAR T-cell therapy that targets multiple markers to see if it can help people with tough-to-treat B cell blood cancers.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Hebei Senlang Biotechnology Inc., Ltd. (industry)
• Drugs / interventions: chimeric antigen receptor, CART
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT05388695 on ClinicalTrials.gov

What this trial studies

This interventional study aims to evaluate the long-term efficacy and safety of dual-target chimeric antigen receptor T cells in patients with refractory relapsed B cell hematologic tumors. It is a single-arm prospective clinical trial that administers autologous CD19/CD22/CD20 CAR T-cell injections based on the expression of tumor cells. Participants will be monitored for adverse reactions and treatment effects over a minimum follow-up period of two years.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with refractory or relapsed B cell tumors that express CD19, CD20, or CD22.

Not a fit: Patients with B cell tumors that do not express the targeted antigens or those with severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with difficult-to-treat B cell hematologic tumors.

How similar studies have performed: Other studies utilizing CAR T cell therapies have shown promising results, indicating potential for success with this dual-target approach.

Eligibility criteria

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.

Where this trial is running

Wuhan, Hubei

• Tongji Hospital — Wuhan, Hubei, China (RECRUITING)

Study contacts

• Principal investigator: Jia Wei, PhD&MD — Tongji Hospital
• Study coordinator: Jia Wei, PhD&MD

Conditions: 19 and 22+ B Cell Hematologic Tumors, 19 and 20+ B Cell Hematologic Tumors