Clincosm LogoSign in Get a demo

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

Sponsor
Second Affiliated Hospital of Xi'an Jiaotong University (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04094766
Collaborator
Nanjing Legend Biotech Co. (Industry)
0
Enrollment
1
Location
1
Arm
37
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a single arm, open-label, dose escalation clinical study to evaluate the safety and efficacy of infusion of dual specificity CD19 and CD22 CAR-T cells in patients with relapsed and refractory acute B lymphoblastic leukemia.

Condition or Disease Intervention/Treatment Phase
  • Drug: Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy
 Phase 1

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I Clinical Study of Dual Specificity CD19 and CD22 Chimeric Antigen Receptor T Cell Therapy in Relapsed or Refractory Acute B Lymphoblastic Leukemia
Actual Study Start Date :
Aug 1, 2017
Anticipated Primary Completion Date :
Aug 30, 2020
Anticipated Study Completion Date :
Aug 30, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: BLLCAR-L10D treatment group

In BLLCAR-L10D treatment group, patients will be treated with dual specificity CD19 and CD22 CAR-T cells with a escalation approach, 3 CAR-T dosage will be tested in this study: 0.5×10^6, 1.5×10^6, 2.0×10^6 CAR-T cells/kg.

Drug: Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy
Patients will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of CAR-T cells. After a pre-treatment lymphodepletion therapy, patients will receive the Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy by intravenous injection.

Outcome Measures

Primary Outcome Measures

  1. Occurrence of treatment related adverse events [Day 1-100 days after injection]

    Assessed by CTCAE v4.0

Secondary Outcome Measures

  1. Objective response rate [Day 1-5 years after injection]

    Objective response include complete remission and partial remission

  2. Overall survival [Day 1-5 years after injection]

  3. Progression free survival [Day 1-5 years after injection]

Other Outcome Measures

  1. Copy numbers of CAR-T cells in patients [Day 1-5 years after injection]

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Written informed consent could be acquired;

  2. Diagnosed with relapse/refractory acute lymphoblastic leukemia;

  3. Relapse was defined as recurrence of blast cell(more than 5%) in peripheral blood or in bone marrow or extramedullary involvement;

  4. Refractory was defined as failed to achieve complete remission after two courses of induction therapy;

  5. CD19/CD22 postive leukemia cell was confirmed by flow cytometry or immunohistochemistry within 90 days since enrollment in this trial;

  6. Karnofsky score ≥70;

  7. Results of pregnant test should be negative, and agree to conception control during treatment and 6 months after CAR-T infusion.

  8. Adequate organ function: EF≥50%; normal ECG; CCR ≥ 50ml/min or Cr < 2.0mg/dL or < 2 times upper limitation of normal; ALT and AST<5 times upper limitation of normal; Serum bilirubin ≤ 3.0mg/dL; DLCO or FEV1 > 45% of predict value;

  9. At least 2 weeks intervals since the last chemotherapy;

  10. At least 2 weeks intervals since the last anti-GVHD therapy if patients have ever ;

Exclusion Criteria:

  1. Patients diagnosed with acute promyelocytic leukemia:t(15;17)(q22;q12);

  2. Women in pregnancy and lactation;

  3. Uncontrolled infection, Active HBV or HCV infection, HIV positive or any other deadly bacterial/virual diseases;

  4. Long term use of systemic corticosteroids(5mg per day for 2 weeks);

  5. Any other uncontrolled life-threaten diseases;

  6. Patients with history of anaphylaxis to any drugs;

  7. With central nervous system (CNS) involvement;

  8. Patients with GVHD after allo-HSCT who needed immunosuppressive agents ;

  9. Patients with acute autoimmune diseases such as psoriasis or rheumatoid arthritis;

  10. Other conditions that principle investigator considered may increase the risk of the patients or interference the results.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Second Affiliated Hospital of Xi'an Jiaotong University Xi'an Shaanxi China 710000

Sponsors and Collaborators

  • Second Affiliated Hospital of Xi'an Jiaotong University
  • Nanjing Legend Biotech Co.

Investigators

  • Principal Investigator: Aili He, MD, PhD, Second Affiliated Hospital of Xi'an Jiaotong University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Second Affiliated Hospital of Xi'an Jiaotong University
ClinicalTrials.gov Identifier:
NCT04094766
Other Study ID Numbers:
  • XJTU-BLLCAR-L10D
First Posted:
Sep 19, 2019
Last Update Posted:
Nov 5, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Second Affiliated Hospital of Xi'an Jiaotong University
Chimeric Antigen Receptor T cells
CD19 and CD22
Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid

Study Results

No Results Posted as of Nov 5, 2020