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

Sponsor
Kecellitics Biotech Company Ltd (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05651100
Collaborator
Hebei Yanda Ludaopei Hospital (Other)
50
1
1
36
1.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: CD19 and CD22 targeted CAR-T cells
Phase 1/Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Dec 10, 2022
Anticipated Primary Completion Date :
Dec 10, 2024
Anticipated Study Completion Date :
Dec 10, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: arm 1

sequential CD19 and CD22 targeted CAR-T cells treat

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).

Outcome Measures

Primary Outcome Measures

  1. 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).

  2. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hebei Yanda Ludaopei Hospital Langfang Hebei China 065201

Sponsors and Collaborators

  • Kecellitics Biotech Company Ltd
  • Hebei Yanda Ludaopei Hospital

Investigators

  • Study Chair: li xiangqun, doctor, Kecellitics Biotech Company Ltd

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kecellitics Biotech Company Ltd
ClinicalTrials.gov Identifier:
NCT05651100
Other Study ID Numbers:
  • Kece-4
First Posted:
Dec 14, 2022
Last Update Posted:
Dec 14, 2022
Last Verified:
Dec 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kecellitics Biotech Company Ltd
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 14, 2022