Immunotherapy using CD19 and CD22 CAR-T cells for B cell lymphoma

A Clinical Study to Evaluate the Safety and Effectiveness of CD19-CD22 CAR-T Cells Immunotherapy in Patients With Relapsed or Refractory B Cell Lymphoma

This study is testing a new type of immunotherapy using CD19 and CD22 CAR-T cells to see if it can help people with B cell lymphoma that hasn't responded to previous treatments.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 6 Years to 70 Years
• Sex: All
• Sponsor: Shanxi Province Cancer Hospital (Academic / other)
• Drugs / interventions: CAR-T, cyclophosphamide, immunotherapy
• Locations: 1 site (Taiyuan, Shanxi)
• Trial ID: NCT04715217 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, tolerability, and preliminary efficacy of CD19-CD22 CAR-T cell immunotherapy in patients with relapsed or refractory B cell lymphoma. It is a non-randomized trial that plans to enroll 24 subjects, who will be divided into low, medium, and high dose groups. The study aims to observe pharmacokinetics and pharmacodynamics parameters alongside treatment outcomes. Participants will be monitored for their response to the therapy after having undergone at least two prior treatments without achieving a partial response.

Who should consider this trial

Good fit: Ideal candidates are patients aged 6 to 70 with recurrent or refractory B cell lymphoma who have not responded to previous treatments.

Not a fit: Patients with B cell lymphoma who have not undergone at least two prior treatments or those with non-measurable lesions may not benefit from this study.

Why it matters

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

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

Eligibility criteria

Inclusion Criteria:

1. 6-70 - year - old male or female subjects (including 6 years old and 70 years old, 6-18 subjects use only the recommended dose of treatment);
2. The Clinical diagnosis of recurrent/refractory B cell lymphoma, after at least 2 courses of treatment, has not been achieved partial response, still in the continuous phase and progress, including the MRD positive, or recurrent intramedullary patients；
3. Bone marrow samples inspection by using flow cytometry or organization pathology ，the cell membrane surface antigen CD19 and/or CD22 positive；
4. Patients with lymphoma need to have a measurable lesions, measurable target lesions: lymph node x1.0 \> 1.5 cm, outside the junction lesions \> x1.0 1.0 cm;
5. ECOG physical status score of 0 to 2 points;
6. Expected lifetime is more than 12 weeks;
7. The clinical laboratory test results of screening phase meet the following criteria: (7 days before the inspection without blood transfusion) Hb≥60 g/L (allowed to use recombinant human erythropoietin); PLT≥ 50 x 10 \^ 9 / L ; ALC≥0.3×10\^9/L; ANC≥0.75×10\^9/L (allowed to use granulocyte colony stimulating factor); AST≤3ULN,ALT≤3ULN,TBIL≤2ULN；Ccr≥30 mL/min/1.73 m2；
8. Cardiopulmonary function: left ventricular ejection fraction \> 40%; Baseline blood oxygen saturation \> 95%;
9. Has a history of allogeneic/allogeneic hematopoietic stem cell transplantation patients: transplantation in 3 months ago, no grade 2 or more active graft versus host disease (GVHD), more than a month without immune inhibitors.

Exclusion Criteria:

1. The active hepatitis b, HBV - DNA detection lower limit of the subjects above research center; Hepatitis c virus (HCV) antibody positive and peripheral blood HCV - RNA positive subjects; Antibodies to HIV positive subjects; Early syphilis screening antibody positive;
2. The other clinical significance of active virus, bacterial infection, or failing to control systemic fungal infection;
3. Any instability of systemic disease, including but not limited to, unstable angina, cerebrovascular accident, or transient ischemic (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), New York heart association (NYHA) classification level III or higher congestive heart failure, drug control of serious arrhythmia, liver, kidney or metabolic diseases, as well as the standard treatment cannot control high blood pressure;
4. In past two years, because of autoimmune diseases such as crohn's disease, rheumatoid arthritis and systemic lupus erythematosus (sle), etc.) causing end-organ damage, or need systemic application of immunosuppressive drugs;
5. Had a history of the central nervous system diseases, such as epilepsy, serious brain damage, dementia, Parkinson's disease, psychosis,etc which influence the appraising of test,;
6. Diagnosed with other active malignancy in past five years(the basal or scaly skin cancer, superficial bladder cancer, breast cancer in situ, which has been cured and does not require follow-up treatment are not included );
7. Known allergic to cyclophosphamide, fluorine dara marina or CAR - T cell s including accessories, DMSO ;
8. Patients with pregnancy or lactation, patients do not want to take effective contraceptive measures within 6months after infusion CAR-T cells;
9. The other situations that researchers determined doesn't fit to participate in this study.

Where this trial is running

Taiyuan, Shanxi

• Hematology Department of ShanXi Cancer Hospital — Taiyuan, Shanxi, China (Recruiting)

Study contacts

• Principal investigator: Liping Su, M.D. — Hematology Department of ShanXi Cancer Hospital
• Study coordinator: Liping Su, M.D.

Conditions Lymphoma, B-Cell