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Not yet recruitingNCT05651100Updated Dec 14, 2022

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

A Phase 1/2 interventional study of CD19 and CD22 targeted CAR-T cells in Lymphoma, B-Cell, sponsored by Kecellitics Biotech Company Ltd. Not yet recruiting at 1 site in China. Open to participants aged 3 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-12-14.

Sponsored by Kecellitics Biotech Company Ltd · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 1/2
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
3 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Lymphoma, B-Cell

Keywords

  • CAR-T
  • Lymphoma
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 50 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Kecellitics Biotech Company Ltd is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 70 Years
Sexes eligible
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

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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    arm 1

    sequential CD19 and CD22 targeted CAR-T cells treat

    Biological: CD19 and CD22 targeted CAR-T cells

Interventions

  • BiologicalCD19 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).

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 1 years

  2. 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.

    Time frame: 3 months

Secondary outcomes

  1. 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.

    Time frame: 24 months

  2. 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.

    Time frame: 24 months

  3. 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.

    Time frame: 24 months

  4. 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.

    Time frame: 24 months

  5. 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.

    Time frame: 24 months

07

Study locations

1 site
  • Hebei Yanda Ludaopei Hospital
    Langfang, Hebei 065201, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05651100
Lead sponsor
Kecellitics Biotech Company Ltd
Collaborators
Hebei Yanda Ludaopei Hospital
Responsible party
Sponsor
First posted
Dec 14, 2022
Start date
Dec 10, 2022 (estimated)
Primary completion
Dec 10, 2024 (estimated)
Completion
Dec 10, 2025 (estimated)
Last update
Dec 14, 2022

Study contacts

li xiangqun, doctor
Contact
xiangqun_li@doingtimes.com
086-15712867910
li xiangqun, doctor
study chair · Kecellitics Biotech Company Ltd

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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