Safety and Efficacy of Sequential CD19 and CD22 Targeted CAR-T Therapy for Relapsed/Refractory B Cell Lymphoma

Phase 1

Not yet recruiting

• Conditions: Lymphoma, B-Cell
• Interventions: Biological: CD19 and CD22 targeted CAR-T cells

• Registration Number: NCT05651100
• Lead Sponsor: Kecellitics Biotech Company Ltd

Brief Summary

This is a single arm study to evaluate the efficacy and safety of Sequential CD19 and CD22 targeted CAR-T cells therapy for patients with relapsed/refractory B Cell Lymphoma.

Detailed Description

Although the CD19 targeted CAR-T cell therapies have gained significant results in patients with relapsed and refractory B-cell Leukemia and Lymphoma. There are some patients who resisted anti-CD19 CAR-T cells or get CD19 negative relapse. To make further improvement, We launch such a clinical trial using sequential CD19 and CD22 targeted CAR-T cells for patients with relapsed and refractory B Cell Lymphoma to evaluate the efficacy and safety of sequential CD19 and CD22 targeted CAR-T cell therapy.

Study Timeline

• Study First Submitted: 2022-11-26
• Status Verified: 2022-12
• Study First Submitted QC: 2022-12-06
• Last Update Submitted: 2022-12-06
• Study Start: 2022-12-10
• Study First Posted: 2022-12-14
• Last Update Posted: 2022-12-14
• Primary Completion: 2024-12-10
• Study Completion: 2025-12-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Relapsed or refractory B cell non-hodgkin lymphoma.
2. KPS>60.
3. Life expectancy>12 weeks.
4. Gender unlimited, age from 3 years to 70 years.
5. Evidence for cell membrane CD19 and/or CD22 expression;
6. Patients who have failed at least one line of a standard treatment.
7. No serious mental disorder.
8. Patients must have adequate cardiac function(no cardiac disease, LVEF≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of >94%, and adequate renal function(Cr≤133umol/L).
9. No other serious diseases(autoimmune disease, immunodeficiency etc.).
10. No other tumors.
11. Patients volunteer to participate in the research.
12. Patients with history of allogeneic stem cell transplantation are eligible if at least 100 days post-transplant, if there is no evidence of active GVHD and no longer taking immunosuppressive agents for at least 30 days prior to trial

Exclusion Criteria

1. Pregnancy and nursing females.
2. Patients are allergic to cytokines.
3. Uncontrolled active infection.
4. Acute or chronic GVHD.
5. Treated with T cell inhibitor.
6. Patients who had used steroid hormones within one week.
7. Patients who had used Rituximab within two weeks.
8. HIV/HBV/HCV Infection.
9. Other situations we think improper for the research.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
arm 1	CD19 and CD22 targeted CAR-T cells	sequential CD19 and CD22 targeted CAR-T cells treat

Primary Outcome Measures

Name	Time	Method
Adverse events that related to treatment	1 years	Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).
Overall remission rate (ORR)	3 months	The ORR of Sequential CD19 and CD22 CAR-T treatment will be recorded and assessed according to the revised 2014 Lugano Criteria.

Secondary Outcome Measures

Name	Time	Method
partial response(PR)	24 months	The PR of Sequential CD19 and CD22 CAR-T treatment will be recorded and assessed according to the revised 2014 Lugano Criteria.
progressive disease(PD)	24 months	The PD of Sequential CD19 and CD22 CAR-T treatment will be recorded and assessed according to the revised 2014 Lugano Criteria.
stable disease(SD)	24 months	The SD of Sequential CD19 and CD22 CAR-T treatment will be recorded and assessed according to the revised 2014 Lugano Criteria.
complete response(CR)	24 months	The CR of Sequential CD19 and CD22 CAR-T treatment will be recorded and assessed according to the revised 2014 Lugano Criteria.
Duration of remission (DOR)	24 months	DOR will be assessed from the first assessment of CR/CRi to the first assessment of recurrence or progression of the disease or death from any cause.

Trial Locations

Locations (1)

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