NCT03173417

Brief Summary

Assessment of the Safety and Feasibility of Administering T Cells Expressing an Anti-CD19 Chimeric Antigen Receptor to Patients With CD19+ B-cell leukemia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
177

participants targeted

Target at P75+ for phase_1 leukemia

Timeline
Completed

Started May 2017

Shorter than P25 for phase_1 leukemia

Geographic Reach
1 country

1 active site

Status
completed

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

May 23, 2017

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 30, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 1, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

May 20, 2019

Status Verified

May 1, 2019

Enrollment Period

1.9 years

First QC Date

May 30, 2017

Last Update Submit

May 17, 2019

Conditions

Leukemia

Outcome Measures

Primary Outcomes (1)

  • Occurrence of study related adverse events

    defined as \>= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment Adverse events assessed according to NCI-CTCAE v4.0 criteria 2.

    2 years

Secondary Outcomes (1)

  • Overall response rate

    2 years

Study Arms (1)

IM19 CART

EXPERIMENTAL

All patients will be treated with fludarabine and cyclophosphamide for 3 days,then,CAR-T cells expressing CD19 CAR will be infused 24-96 hours later.

Biological: IM19 CAR-TDrug: fludarabine and cyclophosphamide

Interventions

IM19 CAR-TBIOLOGICAL

T Cells Expressing an Anti-CD19 Chimeric Antigen Receptor

Also known as: IM19
IM19 CART
fludarabine and cyclophosphamideDRUG

Two days before cell infusion,all patients will be treated with fludarabine and cyclophosphamide for 3 days

Also known as: FC
IM19 CART

Eligibility Criteria

Age3 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with CD19+ Refractory or Relapsed B-ALL（At least 2 prior combination chemotherapy regimens）
  • To be aged 3 to 75 years
  • Blast in blood ≤ 30%
  • ECOG score ≤2
  • Women of childbearing potential must have a urine pregnancy test taken and proven negative prior to the treatment. All patients agree to use reliable methods of contraception during the trial period and until follow-up for the last time.
  • Voluntary participation in the clinical trials and sign the informed consent.

You may not qualify if:

  • Intracranial hypertension or unconsciousness
  • Respiratory failure
  • CD19 negative
  • Disseminated intravascular coagulation
  • ALT /AST\>3 x normal value; Creatinine\> 1.5 x normal value; Bilirubin \>2.0 x normal value
  • Hematosepsis or Uncontrolled active infection
  • Uncontrolled diabetes
  • Abalienation;
  • WHO Sscore \>3
  • Patients in pregnancy or breast-feeding period
  • Previously treatment with any gene therapy products
  • Any uncontrolled medical disorders that the researchers consider are not eligible to participate the clinical trial
  • Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hebei Yanda Ludaopei Hospital

Beijing, China

Location

Related Publications (2)

  • Chen M, Fu M, Wang A, Wu X, Zhen J, Gong M, Zhang X, Yue G, Du Q, Zhao W, Zhao Y, Lu P, Wang H. Cytoplasmic CD79a is a promising biomarker for B lymphoblastic leukemia follow up post CD19 CAR-T therapy. Leuk Lymphoma. 2022 Feb;63(2):426-434. doi: 10.1080/10428194.2021.1980214. Epub 2021 Oct 21.

    PMID: 34672246DERIVED

  • Zhang X, Lu XA, Yang J, Zhang G, Li J, Song L, Su Y, Shi Y, Zhang M, He J, Song D, Lv F, Li W, Wu Y, Wang H, Liu H, Zhou X, He T, Lu P. Efficacy and safety of anti-CD19 CAR T-cell therapy in 110 patients with B-cell acute lymphoblastic leukemia with high-risk features. Blood Adv. 2020 May 26;4(10):2325-2338. doi: 10.1182/bloodadvances.2020001466.

    PMID: 32453841DERIVED

MeSH Terms

Conditions

Leukemia

Interventions

fludarabineCyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Study Officials

  • PEIHUA LU, MD

    Hebei Yanda Ludaopei Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 30, 2017

First Posted

June 1, 2017

Study Start

May 23, 2017

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

May 20, 2019

Record last verified: 2019-05

Locations

CN(1)