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

NCT05651100 | Unknown Phase 1

• 1 other identifier: Kece-4
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoma, B-Cell

Keywords

CAR-T; Lymphoma

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• complete response(CR)

  24 months

• partial response(PR)

  24 months

• stable disease(SD)

  24 months

• progressive disease(PD)

  24 months

• Duration of remission (DOR)

  24 months

Study Arms (1)

arm 1

EXPERIMENTAL

sequential CD19 and CD22 targeted CAR-T cells treat

Biological: CD19 and CD22 targeted CAR-T cells

Interventions

CD19 and CD22 targeted CAR-T cells BIOLOGICAL

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).

arm 1

Eligibility Criteria

• Age: 3 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Relapsed or refractory B cell non-hodgkin lymphoma.
• KPS\>60.
• Life expectancy\>12 weeks.
• Gender unlimited, age from 3 years to 70 years.
• Evidence for cell membrane CD19 and/or CD22 expression;
• Patients who have failed at least one line of a standard treatment.
• No serious mental disorder.
• 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).
• No other serious diseases(autoimmune disease, immunodeficiency etc.).
• No other tumors.
• Patients volunteer to participate in the research.
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Kecellitics Biotech Company Ltd: lead
• Hebei Yanda Ludaopei Hospital: collaborator

Study Sites (1)

Hebei Yanda Ludaopei Hospital

Langfang, Hebei, 065201, China

Location

MeSH Terms

Conditions

Lymphoma, B-Cell; Lymphoma

Interventions

Antigens, CD19

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antigens, CD; Antigens, Differentiation; Antigens, Surface; Antigens; Biological Factors; Antigens, Differentiation, B-Lymphocyte; Minor Histocompatibility Antigens; Histocompatibility Antigens; Isoantigens; Biomarkers

Study Officials

• li xiangqun, doctor

  Kecellitics Biotech Company Ltd

  STUDY CHAIR

Central Study Contacts

li xiangqun, doctor

CONTACT

086-15712867910; xiangqun_li@doingtimes.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2022
• First Posted: December 14, 2022
• Study Start: December 10, 2022
• Primary Completion: December 10, 2024
• Study Completion: December 10, 2025
• Last Updated: December 14, 2022

Record last verified: 2022-12

Locations

CN (1)