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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05651100
Other study ID # Kece-4
Secondary ID
Status Not yet recruiting
Phase Phase 1/Phase 2
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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