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Status unknownNCT05225831Updated Feb 7, 2022

Safety and Efficacy of CD19/CD22 Dual Targeted CAR-T Cell Therapy in R/R B-Cell Acute Lymphoblastic Leukemia

An Early Phase 1 interventional study of Autologous CD19/CD22 Chimeric Antigen Receptor T-cells and Cyclophosphamide,Fludarabine in CD19+ and CD 22+ B-ALL, sponsored by Hebei Senlang Biotechnology Inc., Ltd.. Status unknown at 1 site in China. Open to participants aged 2 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-02-07.

Sponsored by Hebei Senlang Biotechnology Inc., Ltd. · Early Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2022), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Aug 2021, registered Jan 2022).
Phase
Early Phase 1
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
2 Years to 70 Years
Sex
All
01

Study summary

This is an open, single-arm, prospective clinical study to evaluate the safety and efficacy of anti CD19 and CD22 CAR-T cell in the treatment of R/R B-ALL.

Read the detailed description

CD19-directed CAR-T cell therapy has shown promising results in the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia. CD19 and CD22 are proteins usually expressed on the surface of the B leukemia cells. The dual-CARs enables the T-cells to recognize and kill the tumor cell through recognition of CD19 and CD22.

02

Conditions studied

  • CD19+ and CD 22+ B-ALL

Keywords

  • CD19
  • CD22
  • B-ALL
  • CAR-T
03

In context

Precursor Cell Lymphoblastic Leukemia-Lymphoma

2,061 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 490 are open to participants now.

This study's planned enrollment of 100 is above the median of 40 across 1,653 interventional studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.

Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →

Lead sponsor

Hebei Senlang Biotechnology Inc., Ltd. is the lead sponsor of 40 studies on the registry; 15 are open to participants now.

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

04

Who can participate

Ages eligible
2 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Sign the informed consent and be willing and able to comply with the visit, treatment regimen, laboratory examination and other requirements of the study as stipulated in the trial flow chart;
  2. A definite diagnosis of B-cell Lymphocyte Leukemia, which meets any of the following criteria: Relapsed : a) relapsed within 12 months after first remission;Refractory: a) no remission after six weeks of induction therapy or no remission after two courses of induction therapy; b) relapsedafter CR for 2 or more times; c) The first relapse after chemotherapy and no remission after at least one salvage treatment; c) relapsed after hematopoietic stem cell transplantation;
  3. ECOG Scores: 0\~2
  4. CD19 positive and CD22 positive were detected by immunohistochemistry or flow cytometry;
  5. Estimated survival time>3 months;
  6. Peripheral blood mononuclear immune cells must be collected at least 2 weeks after the last radiotherapy or systemic treatment.
  7. For patients with only extramedullary recurrence of B-ALL, there must be at least one assessable lesion.

Exclusion criteria

Exclusion Criteria:

  1. Serious cardiac insufficiency；
  2. Has a history of severe pulmonary function damaging;
  3. Presence of other malignant tumors.
  4. Presence of active fungal, bacterial, viral, or other infection requiring IV antibiotics for management.
  5. Presence of other severe autoimmune diseases or immunodeficiency disease;
  6. Patients with active hepatitis B or hepatitis C([HBVDNA+]or [HCVRNA+]);
  7. Known positive serology for human immunodeficiency virus (HIV) or syphilis。
  8. Has a history of serious allergies on biological products (including antibiotics);
  9. Female patients who are under pregnancy and/or lactation, or planing on pregnancy for the next 12 months.
  10. Any other situations that the researchers believe will affect the results of the study.
05

Study design

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

Study arms

  • Experimental
    SL19+22 CAR-T

    Eligible patients will be treated with SL19+22 CAR-T.

    Biological: Autologous CD19/CD22 Chimeric Antigen Receptor T-cells · Drug: Cyclophosphamide,Fludarabine

Interventions

  • BiologicalAutologous CD19/CD22 Chimeric Antigen Receptor T-cells

    A single infusion of CD19 and CD22 CAR-T cells.

    Also known as: SL19+22 CAR-T

  • DrugCyclophosphamide,Fludarabine

    Given

06

What researchers measure

Primary outcomes

  1. Safety: Incidence of adverse events

    To evaluate the possible adverse events that could occurred within the first month post SL19+22 infusion, including symptoms such as cytokine release syndrome and neurotoxicity.

    Time frame: up to 28 days

  2. Efficacy: Remission Rate

    Remission Rate includes complete remission(CR)、CR with incomplete blood count recovery(CRi)、No remission(NR)

    Time frame: Up to 3 months

Secondary outcomes

  1. Efficacy:duration of response (DOR)

    Duration of response

    Time frame: 24 months post CAR-T cells infusion

  2. Efficacy: progression-free survival (PFS)

    progression-free survival (PFS) time

    Time frame: 24 months post CAR-T cells infusion

  3. CAR-T proliferation

    the copy number of CD19 and CD22 CAR- T cells in the genomes of peripheral blood mononuclear cell (PBMC) by quantitative Real-time PCR (qPCR).

    Time frame: 3 months post CAR-T cells infusion

  4. Cytokine release

    Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry

    Time frame: First month post CAR-T cells infusion

07

Study locations

1 of 1 sites recruiting
  • Hebei Yanda Ludaopei Hospital
    Langfang, Hebei, China
    • Peihua LU, PhD&MD · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05225831
Lead sponsor
Hebei Senlang Biotechnology Inc., Ltd.
Collaborators
Hebei Yanda Ludaopei Hospital
Responsible party
Sponsor
First posted
Feb 7, 2022
Start date
Aug 15, 2021
Primary completion
Aug 2023 (estimated)
Completion
Nov 2023 (estimated)
Last update
Feb 7, 2022

Study contacts

Peihua Lu, PhD&MD
Contact
peihua_lu@126.com
008618611636172
Jianqiang Li, PhD&MD
Contact
limmune@gmail.com
008615511369555
Peihua Lu, PhD&MD
principal investigator · Beijing Lu Daopei Hospital

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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