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CD19-CAR-T2 Cells for CD19 Positive Acute Lymphoblastic Leukemia

Sponsor
Nanfang Hospital of Southern Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04605666
Collaborator
(none)
60
Enrollment
1
Location
1
Arm
14
Anticipated Duration (Months)
4.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Relapsed and refractory B cell acute lymphoblastic leukemia (B-ALL) shows unfavorable prognosis, especially for adult patients. Besides, minimal residual disease (MRD) positive at transplant has been considered risk factor for relapse after transplantation. Worse yet, there is no standard management for these patients. Chimeric antigen receptor T cells (CAR-T cells) has been recognized a promising treatment option for treating B cell derived malignancy. The purpose of this study is to evaluate the efficacy and safety of chimeric antigen receptor 19 (CD19-CAR-T2 Cells) infusions in patients with CD19+ ALL.

Condition or Disease Intervention/Treatment Phase
  • Biological: CD19-CAR-T2 Cells
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
CD19-Chimeric Antigen Receptor-T2 Cells for CD19 Positive Acute Lymphoblastic Leukemia
Actual Study Start Date :
May 1, 2020
Anticipated Primary Completion Date :
Dec 31, 2020
Anticipated Study Completion Date :
Jun 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: CAR-T group

Biological: CD19-CAR-T2 Cells
CD19-CAR-T2 T cells will be infused over 10-15 minutes on Day 0.

Outcome Measures

Primary Outcome Measures

  1. ORR [3 months]

    Overall Response Rate includes Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi), as determined by assessments of peripheral blood, bone marrow, CNS symptoms, physical exam (PE) and CSF. The primary endpoint will be based on the IRC assessment. The local investigator's assessed results will be used for sensitivity analysis.

Secondary Outcome Measures

  1. ORR [6 months]

  2. ORR [12 months]

  3. Adverse Events [12 months]

  4. OS [1 year]

    overall survival

  5. DFS [1 year]

    disease-free survival

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Patient with CD19 positive B-cell acute leukemia

  • Eastern Cooperative Oncology Group (ECOG) performance status <2

  • ALT/ AST <3 x normal

  • Bilirubin < 2.0 mg/dl

  • Creatinine < 2.5 mg/dl and less than 2.5x normal for age

  • LVEF< 45%

  • Accept white blood cell collection

  • Provide informed consent

Exclusion Criteria:

  • Previous treatment with investigational gene or cell therapy medicine products

  • Active hepatitis B , hepatitis C or HIV infection

  • Uncontrolled active infection

  • Presence of grade 2-4 acute or extensive chronic GVHD

  • Active CNS involvement: epilepsy, paresis, aphasia, stroke, severe head trauma,

  • Dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, uncontrolled mental illness, etc.

  • Any uncontrolled active medical disorder that would preclude participation as outlined.

  • Received non-diagnostic purposes major surgery within the past 4 weeks

  • Participated in any other clinical study within the past 4 weeks

  • Used murine biological products (except blinatumomab), unless it is proved no anti-mouse antibodies exist.

  • Pregnancy or breast-feeding women

  • Use of prohibited drugs:

  • Steroids: Therapeutic doses of steroids must be stopped > 72 hours prior to CD19-CAR-T2 Cells infusion

  • Allogeneic cellular therapy: Any donor lymphocyte infusions (DLI) must be completed > 4 weeks prior to CD19-CAR-T2 Cells infusion

  • GVHD therapies: Any drug used for GVHD must be stopped > 4 weeks prior to CD19-CAR-T2 Cells infusion

  • Any situation that may increase the risk of the test or interfere with the test results

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nanfang Hospital, Southern Medical University Guangzhou Guangdong China 510515

Sponsors and Collaborators

  • Nanfang Hospital of Southern Medical University

Investigators

  • Principal Investigator: Qi-fa Liu, MD, Nanfang Hospital of Southern Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Qifa Liu, Professor, Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier:
NCT04605666
Other Study ID Numbers:
  • CAR-T-ALL-2020
First Posted:
Oct 28, 2020
Last Update Posted:
Oct 28, 2020
Last Verified:
Oct 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 Qifa Liu, Professor, Nanfang Hospital of Southern Medical University
acute lymphoblastic leukemia
minimal residual disease
CAR-T
Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid

Study Results

No Results Posted as of Oct 28, 2020