NCT04626726

Brief Summary

This is an open, single-arm, phase I/phase II clinical study to evaluate efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) in the treatment of Relapsed Refractory (R/R) adult acute lymphoblastic leukemia bridging allogeneic hematopoietic stem cell transplantation.

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
50

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Apr 2020

Typical duration for early_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

April 1, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 13, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

3.2 years

First QC Date

November 6, 2020

Last Update Submit

November 11, 2020

Conditions

Adult B Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (2)

  • Number of Participants with Severe/Adverse Events as a Measure of Safety

    Number of Participants with Severe/Adverse Events as a Measure of Safety

    28 days

  • Copies numbers of CAR in peripheral blood(PB) and/or bone marrow(BM)

    Copies numbers of CAR in peripheral blood(PB) and/or bone marrow(BM)

    24 months

Secondary Outcomes (2)

  • Objective response rate of complete remission and partial remission

    24 months

  • Overall survival time

    24 months

Study Arms (1)

Volunteers

EXPERIMENTAL

The patient voluntarily signs the informed consent, and the patient meets the entry criteria to diagnose patients with acute B lymphocytic leukemia expressing specific target antigens

Drug: CD19 CAR-TDrug: CD22 CAR-TDrug: CD19+CD22 CAR-TDrug: FludarabineDrug: Cyclophosphamide

Interventions

CD19 CAR-TDRUG

CD19 CAR-T infusion for patients with CD19 positive tumor cells

Also known as: Senl_19
Volunteers
CD22 CAR-TDRUG

CD22 CAR-T infusion for patients with CD22 positive tumor cells

Also known as: Senl_22
Volunteers
CD19+CD22 CAR-TDRUG

CD19+CD22 CAR-T infusion for patients with CD19 positive and CD22 positive tumor cells

Also known as: Senl_19+22
Volunteers
FludarabineDRUG

25mg/㎡ for D-4、D-3 and D-2

Also known as: fiu
Volunteers
CyclophosphamideDRUG

500mg/㎡ for D-3 and D-2

Also known as: ctx
Volunteers

Eligibility Criteria

Age14 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Be diagnosed a kind of Relapsed or Refractory Haematopoietic and Lymphoid Malignancies:
  • ECOG score≤2;
  • To be aged 1 to 65 years;
  • More than a month lifetime from the consent signing date.

You may not qualify if:

  • Serious cardiac insufficiency, left ventricular ejection fraction\<50%;
  • Has a history of severe pulmonary function damaging;
  • Merging other progressing malignant tumor;
  • Merging uncontrolled infection;
  • Merging the metabolic diseases (except diabetes);
  • Merging severe autoimmune diseases or immunodeficiency disease;
  • Patients with active hepatitis B or hepatitis C;
  • Patients with HIV infection;
  • Has a history of serious allergies on Biological products (including antibiotics);
  • Has acute GvHD on allogeneic hematopoietic stem cell transplantation patients after stopping immunosuppressants a month;
  • Pregnancy or lactation women;
  • 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)

No.2 Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

RECRUITING

MeSH Terms

Conditions

Burkitt Lymphoma

Interventions

fludarabinefiu protein, E coliCyclophosphamideCholestanetriol 26-Monooxygenase

Condition Hierarchy (Ancestors)

Epstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsCytochrome P450 Family 27Cytochrome P-450 Enzyme SystemCytochromesEnzymes and CoenzymesSteroid HydroxylasesMixed Function OxygenasesOxygenasesOxidoreductasesEnzymesHemeproteinsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Jianmin Luo, PhD&MD

    The Second Hospital of Hebei Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianqiang Li, PhD&MD

CONTACT

+8631189928689limmune@gmail.com

Study Design

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

Study Record Dates

First Submitted

November 6, 2020

First Posted

November 13, 2020

Study Start

April 1, 2020

Primary Completion

May 30, 2023

Study Completion

May 30, 2023

Last Updated

November 13, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)