Clincosm LogoSign in Get a demo

Modified CD19 CAR-T in Patients With Relapsed or Refractory CD19+ B-cell Malignancies

Sponsor
Liqun Zou (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04684472
Collaborator
(none)
18
Enrollment
1
Location
1
Arm
33.5
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to evaluate the safety and tolerance of modified CD19 CAR T cells in treating refractory/relapsed B-cell malignancies. CAR-T cells will be investigated as a single agent both in relapsed/refractory B-cell acute lymphoblastic leukaemia (B-ALL) and up to 60% of patients with B-cell non-Hodgkin's lymphoma (NHL).

Condition or Disease Intervention/Treatment Phase
  • Biological: Modified anti-CD19 CAR T cells
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
18 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase I, Open Label, Study of CXCR4 Modified CD19 CAR-T Therapy in Patients With Relapsed or Refractory CD19+ B-cell Malignancies
Actual Study Start Date :
Mar 17, 2021
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Modified anti-CD19 CAR T cell therapy

CAR T cell therapy

Biological: Modified anti-CD19 CAR T cells
intravenous infusion

Outcome Measures

Primary Outcome Measures

  1. Incidence of treatment-emergent adverse events [Safety and Tolerability] [Up to 5 years after modified CD19 CAR-T cells infusion]

    Adverse events assessed according to NCI-CTCAE v5.0 criteria

  2. Dose-limiting toxicity (DLT) [Baseline up to 28 days after modified CD19 CAR-T cells infusion]

    Adverse events assessed according to NCI-CTCAE v5.0 criteria

Secondary Outcome Measures

  1. B-cell malignancies, Overall response rate(ORR) [3 months, 6 months]

    Assessment of ORR(ORR=CR+PR)

  2. B-cell malignancies, Overall survival [Up to 2 years after modified CD19 CAR-T cells infusion]

    From the first infusion of modified CD19 CAR-T cells to death or the last visit

  3. B-cell malignancies, progression-free survival（PFS） [Up to 2 years after modified CD19 CAR-T cells infusion]

    From the first infusion of modified CD19 CAR-T cells to the occurrence of any event, including death, relapse, disease progression, and the last visit

  4. B-cell malignancies, disease control rate (DCR) [Month 6,12,18 and 24]

    Assessment of DCR(DCR=CR+PR+SD)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Male or female aged 18-70 years;

  2. Estimated survival time ≥ 12 weeks;

  3. Histologically confirmed diagnosis of CD19+ B-ALL or CD19+ B-NHL(meeting one of the following conditions):

  4. Ineffectively or relapses after 2 or more remedial treatments

  5. Relapse after auto-HSCT or unsuitable for auto-HSCT;

  6. At least one assessable tumor lesion;

  7. ECOG performance status 0 to 2;

  8. Creatinine clearance rate≥ 60 ml/min, ALT and AST ≤ 2.5 times of upper limit of normal, total bilirubin ≤ 1.5 times of upper limit of normal;

  9. Male and female of reproductive potential must agree to use birth control during the study and for at least 30 days post study;

  10. Patients or their legal guardians volunteer to participate in the study and sign the informed consent.

Exclusion Criteria:

  1. Patients with other uncontrolled malignancies;

  2. Previously treated with any CAR-T cell product or other genetically-modified T cell therapy;

  3. Patients with HIV infection, hepatitis B (HBsAg positive) or hepatitis C（anti-HCV positive);

  4. Patients with central nervous system involvement by lymphoma ,malignant cells in cerebrospinal fluid or history of brain metastasis;

  5. Patients with atrial or ventricular involvement by B-cell malignancies;

  6. Patients with tumor mass require urgent treatment, such as ileus or vascular compression;

  7. Patients with severe disease or other uncontrolled diseases that were not suitable for this trial, such as coronary heart disease, angina pectoris, myocardial infarction, arrhythmia, cerebral thrombosis, cerebral hemorrhage, grade 2-3 hypertension;

  8. Unstable pulmonary embolism, deep venous embolism, or other major arterial/venous thromboembolism events occurred within 30 days prior to randomization. If patients receive anticoagulant therapy, the treatment dose must be stable prior to randomization;

  9. Any situations that the investigators believes were not suitable for this trial;

  10. Long-term use of immunosuppressive agents after organ transplantation, except for the patients recently or currently receiving inhaled steroids;

  11. Pregnant(or lactation) women;

  12. Patients with severe active infections(excluding simple urinary tract infection and bacterial pharyngitis)within 30 days prior to randomization

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sichuan University Chengdu Sichuan China

Sponsors and Collaborators

  • Liqun Zou

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Liqun Zou, Professor of Department of Medical Oncology, Sichuan University
ClinicalTrials.gov Identifier:
NCT04684472
Other Study ID Numbers:
  • MCART-003
First Posted:
Dec 24, 2020
Last Update Posted:
Mar 18, 2021
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Liqun Zou, Professor of Department of Medical Oncology, Sichuan University
Modified CD19 CAR-T
Additional relevant MeSH terms:
Lymphoma, B-Cell

Study Results

No Results Posted as of Mar 18, 2021