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

Lymphoma, B-Cell Clinical Trial

Official title:

Phase 1/Phase 2 Study of Sequential Chimeric Antigen Receptor T Cell Targeting at CD19 and CD22 B-cell Antigens Treating Refractory or Relapsed B-cell Lymphoma Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05651100
• Other study ID #: Kece-4
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: December 10, 2022
• Est. completion date: December 10, 2025

Study information

• Verified date: December 2022
• Source: Kecellitics Biotech Company Ltd
• Contact: li xiangqun, doctor
• Phone: 086-15712867910
• Email: xiangqun_li[@]doingtimes.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 10, 2025
• Est. primary completion date: December 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell

Intervention

Biological:
• CD19 and CD22 targeted CAR-T cells
CAR-T cells were manufactured from peripheral blood mononuclear cells collected by leukapheresis and frozen for multiple uses. Before each CAR T-cell infusion (day 0), patients received lymphodepleting chemotherapy composing of Fludarabine (30 mg/m2/day) and Cyclophosphamide (300 mg/m2/day) on days -5 to -3. No bridging chemotherapy was given between enrollment and infusion. In sequential CAR-T clinical trials, CAR-T cells will be given.(anti-CD19 CAR-T first, then anti-CD22 CAR-T).

Locations

Country	Name	City	State
China	Hebei Yanda Ludaopei Hospital	Langfang	Hebei

Sponsors (2)

Lead Sponsor	Collaborator
Kecellitics Biotech Company Ltd	Hebei Yanda Ludaopei Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events that related to treatment	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).	1 years
Primary	Overall remission rate (ORR)	The ORR of Sequential CD19 and CD22 CAR-T treatment will be recorded and assessed according to the revised 2014 Lugano Criteria.	3 months
Secondary	complete response(CR)	The CR of Sequential CD19 and CD22 CAR-T treatment will be recorded and assessed according to the revised 2014 Lugano Criteria.	24 months
Secondary	partial response(PR)	The PR of Sequential CD19 and CD22 CAR-T treatment will be recorded and assessed according to the revised 2014 Lugano Criteria.	24 months
Secondary	stable disease(SD)	The SD of Sequential CD19 and CD22 CAR-T treatment will be recorded and assessed according to the revised 2014 Lugano Criteria.	24 months
Secondary	progressive disease(PD)	The PD of Sequential CD19 and CD22 CAR-T treatment will be recorded and assessed according to the revised 2014 Lugano Criteria.	24 months
Secondary	Duration of remission (DOR)	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.	24 months