NCT02933775

Brief Summary

This study is designed for determining the safety and relative engraftment levels of the redirected autologous T cells transduced with the anti-CD19 lentiviral vector in patients with CD19-positive B cell leukemia and malignant lymphoma.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2016

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 14, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

October 14, 2016

Status Verified

October 1, 2016

Enrollment Period

1.5 years

First QC Date

October 13, 2016

Last Update Submit

October 13, 2016

Conditions

CD19 Positive Malignant B-cell Leukemia and Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Study related adverse events

    Occurrence of study related adverse events, defined as NCI CTC ≥ Grade 3 signs/symptoms, laboratory toxicities and clinical events that are possible, likely or definitely related to study treatment at any time from the infusion until week 24, including infusional toxicity and any toxicity possibly related to the CAR-CD19 T cells.

    24 weeks

Secondary Outcomes (3)

  • Primary engraftment endpoint

    2 years

  • Anti-tumor responses

    2 years

  • Overall survival

    2 years

Study Arms (1)

CAR-CD19 T cells

EXPERIMENTAL

Autologous T Cells with a CD19-redirected Chimeric Antigen Receptor. Route of administration: Intravenous injection. Lymphodepleting conditioning regimen: A combination of fludarabine and cyclophosphamide will be administered at Day -9 - Day -4.

Genetic: CAR-CD19 T cellsDrug: FludarabineDrug: Cyclophosphamide

Interventions

CAR-CD19 T cellsGENETIC

Initial dose: A total of 1 - 10×10\^7 CAR-CD19 T cells/kg will be administered by 1 - 3 infusions. Subsequent dose will be based on the subject's response to initial dose.

Also known as: CD19 Redirected Autologous Cells
CAR-CD19 T cells
FludarabineDRUG

30 mg/m\^2/day×4 days

CAR-CD19 T cells
CyclophosphamideDRUG

500 mg/m\^2/day×2 days

CAR-CD19 T cells

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with documented CD19-positive malignant B cell leukemia and lymphoma.
  • Patients aged between 18 \~ 65 with malignant B cell leukemia and lymphoma.
  • CD19-positive B cell leukemia or lymphoma.
  • Expected survival \> 12 weeks.
  • ECOG scores 0-1, or KPS scores \> 80.
  • Adequate venous access for apheresis or venous sampling, and no other contraindications for leukapheresis.
  • WBC ≥ 2.5×109/L; LY ≥ 0.7×109/L; LY% ≥ 15%.
  • Creatinine ≤ 2.0 mg/dL (176.8 μmol/L).
  • ALT/AST ≤ 2.5 ULN.
  • Bilirubin ≤ 2.0 mg/dL (34.2 μmol/L).
  • Prothrombin Time (PT) : International Normalized Ratio (INR) \< 1.7, or PT is at most 4 s longer than normal value.
  • All tests results should comply with the above criteria. No continuing supportive care is received.

You may not qualify if:

  • \. CD19-negative B cell leukemia or lymphoma. 2. Feasibility assessment during screening demonstrates \< 5% transduction of target lymphocytes, or insufficient expansion (\< 5-fold) in response to αCD3/CD28 costimulation.
  • \. Previously treatment with any gene therapy products. 9. Allergy to immunotherapy and associated drugs. 10. Patients with heart disease that is in need of treatment or with poorly controlled hypertension determined by investigators.
  • \. Patients with unstable or active ulceration or with gastrointestinal bleeding.
  • \. Patients with previous or planed organ transplantation. 13. Hyponatremia with concentration of sodium in the blood \< 125 mmol/L. 14. Serum potassium (baseline) \< 3.5 mmol/L (Patients can take potassium supplements to recover serum potassium level prior to participating the study).
  • \. Patients need anticoagulant (e.g. Warfarin or heparin). 16. Patients need long-term antiplatelet agent (Aspirin, dose \> 300 mg/d; Clopidogrel, dose \> 75 mg/d).
  • \. Any radiotherapy conducted within 4 weeks prior to blood sampling.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

Location

Related Publications (1)

  • Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.

    PMID: 34515338DERIVED

MeSH Terms

Conditions

Lymphoma

Interventions

fludarabineCyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Study Officials

  • Fangyuan Chen, MD

    RenJi Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Honghui Huang, MD

CONTACT

honghui_huang@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2016

First Posted

October 14, 2016

Study Start

October 1, 2016

Primary Completion

April 1, 2018

Study Completion

January 1, 2020

Last Updated

October 14, 2016

Record last verified: 2016-10

Locations

CN(1)