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Status unknownNCT04792593Updated Mar 11, 2021

Senl-h19 CAR-T Cell Injection in the Treatment of Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

An interventional study of Senl-h19 CAR-T in B-ALL, sponsored by Hebei Senlang Biotechnology Inc., Ltd.. Status unknown at 1 site in China. Open to participants aged 2 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-03-11.

Sponsored by Hebei Senlang Biotechnology Inc., Ltd. · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2021), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Dec 2020, registered Mar 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
2 Years to 70 Years
Sex
All
01

Study 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.

Read the detailed description

Main research objectives:

To evaluate the safety and efficacy of Senl-h19 CAR-T in patients with relapsed or refractory acute lymphoblastic leukemia Secondary research purpose To investigate the cytokinetic characteristics of Senl-h19 CAR-T in patients with relapsed or refractory acute lymphoblastic leukemia.

02

Conditions studied

  • B-ALL

Keywords

  • B-ALL，h19，CAR-T
03

In context

Precursor Cell Lymphoblastic Leukemia-Lymphoma

2,061 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 491 are open to participants now.

This study's planned enrollment of 15 is below the median of 40 across 1,653 interventional studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.

Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →

Lead sponsor

Hebei Senlang Biotechnology Inc., Ltd. is the lead sponsor of 40 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

    1. 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;

Exclusion criteria

Exclusion Criteria:

    1. 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    Senl-h19 CAR-T

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

    Biological: Senl-h19 CAR-T

Interventions

  • BiologicalSenl-h19 CAR-T

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

    Also known as: CD19 CAR-T

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: First 1 month post CAR-T cells infusion

  2. Efficacy: Remission Rate

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

    Time frame: 3 months post CAR-T cells infusion

Secondary outcomes

  1. duration of response (DOR)

    duration of response (DOR)

    Time frame: 24 months post CAR-T cells infusion

  2. progression-free survival (PFS)

    progression-free survival (PFS) time

    Time frame: 24 months post CAR-T cells infusion

  3. CAR-T proliferation

    the copy number of Senl h19 CAR- T cells in the genomes of PBMC by qPCR method

    Time frame: 3 months post CAR-T cells infusion

  4. Cytokine release

    Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry method

    Time frame: First 1 month post CAR-T cells infusion

07

Study locations

1 of 1 sites recruiting
  • Hebei yanda Ludaopei Hospital
    Yanda, Hebei, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04792593
Lead sponsor
Hebei Senlang Biotechnology Inc., Ltd.
Responsible party
Sponsor
First posted
Mar 11, 2021
Start date
Dec 3, 2020
Primary completion
Dec 10, 2021 (estimated)
Completion
Feb 10, 2022 (estimated)
Last update
Mar 11, 2021

Study contacts

Peihua MD Lu, PhD
Contact
peihua_lu@126.com
008618611636172
Jianqiang MD Li, PhD
Contact
limmune@gmail.com
008615511369555
Peihua MD Lu, PhD
principal investigator · Hebei Yanda Ludaopei Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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