CD19/CD20 Dual-CAR-T in B-cell Lymphoma Patients

Phase 1

Completed

• Conditions: B-cell Lymphoma
• Interventions: Biological: CD19/CD20 Dual-CAR-T cells

• Registration Number: NCT04260932
• Lead Sponsor: Hebei Yanda Ludaopei Hospital

Brief Summary

This is a single center, single arm, open-label, phase I study to evaluate the safety and efficacy of CD19/CD20 Dual-CAR-T cells in patients with refractory and relapsed B-cell lymphoma.

Detailed Description

This Phase I study is designed as a pilot trial evaluating the safety and efficacy of CD19/CD20 Dual-CAR-T cell therapy in subjects with refractory and relapsed B cell lymphoma. Subjects will receive cytoreductive chemotherapy with cyclophosphamide and fludarabine on days -5, -4 and -3 followed by infusion of CD19/CD20 Dual-CAR-T cells. Safety and efficacy of CD19/CD20 Dual-CAR-T cells therapy will be monitored. The purpose of current study is to determine the clinical efficacy and safety of CD19/CD20 Dual-CAR-T cells therapy in patients with refractory and relapsed B-cell lymphoma.

Study Timeline

• Study First Submitted: 2020-02-06
• Study First Submitted QC: 2020-02-06
• Study First Posted: 2020-02-07
• Study Start: 2020-03-01
• Primary Completion: 2021-05-10
• Status Verified: 2021-08
• Study Completion: 2021-09-10
• Last Update Submitted: 2022-03-06
• Last Update Posted: 2022-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1. Relapsed and refractory B-cell lymphoma with:

   Relapsed or refractory disease after ≥2 lines of chemotherapy including rituximab and anthracycline and either having failed after autologous or allogeneic hematopoietic stem cell transplantation (ASCT);

2. Patients must have evaluable evidence of disease, including minimal residual disease (MRD);

3. Double positive expression of CD19 / CD20 in B cells;

4. Ages 1 to 80 years, including boundary values;

5. ECOG score 0-3 points;

6. Women of childbearing age (15-49 years old) must receive a pregnancy test within 7 days prior to initiation of treatment and the results are negative; male and female patients with fertility must use an effective contraceptive to ensure 3 months after discontinuation of treatment during the study period not pregnant inside;

7. Patients who voluntarily sign informed consent and are willing to comply with treatment plans.

Exclusion Criteria

1. patients with organ failure:

   • Heart: NYHA heart function grade IV;
   • Liver: Grade C that achieves Child-Turcotte liver function grading;
   • Kidney: kidney failure and uremia;
   • Lung: symptoms of respiratory failure;
   • Brain: a person with a disability;

2. Active infections that are difficult to control;

3. Human immunodeficiency virus (HIV) positive;

4. Liver and kidney function: total bilirubin > 5 × ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 5 × ULN, serum creatinine clearance rate 60mL / min;

5. GVHD ≥ 2 or anti-GVHD treatment;

6. intracranial hypertension or unconsciousness; respiratory failure; diffuse vascular internal coagulation;

7. pregnant or lactating women;

8. The patient does not agree to use effective contraception during the treatment period and for the next 3 months;

9. Patients who participate in other clinical studies at the same time;

10. The investigator believes that there are other factors that are not suitable for inclusion or influence the subject's participation or completion of the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CD19/CD20 Dual-CAR-T cells	CD19/CD20 Dual-CAR-T cells	CD19/CD20 Dual-CAR-T cells are prepared via lentiviral infection. 5 days prior to infusion of CAR-T cells, subjects receive fludarabine at dose 30mg/m2/day and cyclophosphamide treatment at dose 250mg/m2 for 3 days and take a rest for at least 2 days before infusion.

Primary Outcome Measures

Name	Time	Method
Percentage of participants with adverse events.	6 months
Objective remission rate(ORR)	6 months	The percentage of participants who achieved complete remission (CR) and partial remission over all participants.

Secondary Outcome Measures

Name	Time	Method
Relapse-Free Survival(RFS )	6 months
Overall-Survival(OS)	6 months
Persistence of CAR-T cells in vivo	6 months

Trial Locations

Locations (1)

Hebei Yanda Ludaopei Hospital; 🇨🇳 Sanhe, Hebei, China