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

January 25, 2022 updated by: Hebei Senlang Biotechnology Inc., Ltd.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hebei
      • Langfang, Hebei, China
        • Recruiting
        • Hebei Yanda Ludaopei Hospital
        • Contact:
          • Peihua LU, PhD&MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 70 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: SL19+22 CAR-T
Eligible patients will be treated with SL19+22 CAR-T.
Biological: Autologous CD19/CD22 Chimeric Antigen Receptor T-cells
A single infusion of CD19 and CD22 CAR-T cells.
Other Names:
  • SL19+22 CAR-T
Drug: Cyclophosphamide,Fludarabine
Given

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy: Remission Rate
Time Frame: Up to 3 months
Remission Rate includes complete remission(CR)、CR with incomplete blood count recovery(CRi)、No remission(NR)
Up to 3 months
Safety: Incidence of adverse events
Time Frame: up to 28 days
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.
up to 28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy: progression-free survival (PFS)
Time Frame: 24 months post CAR-T cells infusion
progression-free survival (PFS) time
24 months post CAR-T cells infusion
Cytokine release
Time Frame: First month post CAR-T cells infusion
Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry
First month post CAR-T cells infusion
Efficacy:duration of response (DOR)
Time Frame: 24 months post CAR-T cells infusion
Duration of response
24 months post CAR-T cells infusion
CAR-T proliferation
Time Frame: 3 months post CAR-T cells infusion
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).
3 months post CAR-T cells infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hebei Senlang Biotechnology Inc., Ltd.

Collaborators

Hebei Yanda Ludaopei Hospital

Investigators

  • Principal Investigator: Peihua Lu, PhD&MD, Beijing Lu Daopei Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 15, 2021

Primary Completion (ANTICIPATED)

August 1, 2023

Study Completion (ANTICIPATED)

November 1, 2023

Study Registration Dates

First Submitted

January 11, 2022

First Submitted That Met QC Criteria

January 25, 2022

First Posted (ACTUAL)

February 7, 2022

Study Record Updates

Last Update Posted (ACTUAL)

February 7, 2022

Last Update Submitted That Met QC Criteria

January 25, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SL19+22 for B-ALL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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