NCT04792593

Brief Summary

This study is an open, dose-escalating clinical study, taking patients with relapsed or refractory acute lymphoblastic leukemia as the test subjects, including mouse-derived CAR-T treatment failure or relapse, or for any reason cannot bridge the transplant r/r B-ALL.

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
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2020

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

December 3, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 11, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2022

Completed
Last Updated

March 11, 2021

Status Verified

March 1, 2021

Enrollment Period

1 year

First QC Date

March 8, 2021

Last Update Submit

March 8, 2021

Conditions

B-ALL

Keywords

B-ALL，h19，CAR-T

Outcome Measures

Primary Outcomes (2)

  • Safety: Incidence and severity of adverse events

    To evaluate the possible adverse events occurred within first one month after CD7 CAR-T infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity

    First 1 month post CAR-T cells infusion

  • Efficacy: Remission Rate

    Remission Rate including complete remission(CR)、CR with incomplete blood count recovery(CRi)、No remission(NR)

    3 months post CAR-T cells infusion

Secondary Outcomes (4)

  • duration of response (DOR)

    24 months post CAR-T cells infusion

  • progression-free survival (PFS)

    24 months post CAR-T cells infusion

  • CAR-T proliferation

    3 months post CAR-T cells infusion

  • Cytokine release

    First 1 month post CAR-T cells infusion

Study Arms (1)

Senl-h19 CAR-T

EXPERIMENTAL

Patients will be treated with Senl-h19 CAR-T cells

Biological: Senl-h19 CAR-T

Interventions

Senl-h19 CAR-TBIOLOGICAL

Biological: Senl-h19 CAR-T; Drug: Cyclophosphamide,Fludarabine; Procedure: Leukapheresis

Also known as: CD19 CAR-T
Senl-h19 CAR-T

Eligibility Criteria

Age2 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \. Sign the informed consent and be willing and able to comply with the visit, treatment protocol, laboratory examination, and other requirements of the study as specified in the study procedure sheet; 2. A definite diagnosis of relapsed and refractory acute B-lymphoblastic leukemia meets one of the following criteria: a) Mouse CAR-T treatment fails or relapses; B) Unable to bridge the graft for any reason; 3. Eastern Cooperative Oncology Group (ECOG) score ≤2; 4. Age ≥2 years old, male or female 5. CD19 positive tumor cells were detected by immunohistochemistry or flow cytometry; 6. Expected survival longer than 3 months; 7. The collection time of peripheral blood mononuclear immune cells must be at least 2 weeks from the last radiotherapy or systematic treatment of patients;

You may not qualify if:

  • \. Severe cardiac insufficiency; 2. Have a history of severe lung impairment; 3. Complicated with other advanced malignant tumors; 4. Complicated with severe or persistent infection that cannot be effectively controlled; 5. Complicated with severe autoimmune diseases or congenital immune deficiency; 6. Active hepatitis (HBVDNA or HCVRNA positive); Human immunodeficiency virus (HIV) infection or syphilis infection; 8. Have a history of severe allergy to biological products (including antibiotics); 9. The female patient is pregnant and lactating, or has a pregnancy plan within 12 months; 10. Conditions that the investigator believes may increase the risk to the subject or interfere with the outcome of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hebei yanda Ludaopei Hospital

Yanda, Hebei, China

RECRUITING

Study Officials

  • Peihua MD Lu, PhD

    Hebei Yanda Ludaopei Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peihua MD Lu, PhD

CONTACT

008618611636172peihua_lu@126.com

Jianqiang MD Li, PhD

CONTACT

008615511369555limmune@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Open Label
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single Group Assignment
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2021

First Posted

March 11, 2021

Study Start

December 3, 2020

Primary Completion

December 10, 2021

Study Completion

February 10, 2022

Last Updated

March 11, 2021

Record last verified: 2021-03

Locations

CN(1)