CClinicalTrials.gg
Sign In
Status unknownNCT04626765Updated Nov 13, 2020

CAR-T for Children With Relapsed and Refractory Acute Lymphoblastic Leukemia

An Early Phase 1 interventional study of CD19 CAR-T and CD22 CAR-T in Childhood Acute Lymphoblastic Leukemia, sponsored by Hebei Senlang Biotechnology Inc., Ltd.. Status unknown at 1 site in China. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2020-11-13.

Sponsored by Hebei Senlang Biotechnology Inc., Ltd. · Early Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2020), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Apr 2020, registered Nov 2020).
Phase
Early Phase 1
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
1 Year to 18 Years
Sex
All
01

Study summary

In this study, CAR-T will be administered to children with acute lymphoblastic leukemia to explore the effect of CAR-T intervention time on the duration of complete remission and further verify the long-term safety and efficacy of CAR-T treatment.

Read the detailed description

After clinician evaluation, if the child meets the study criteria and after adequate communication, the parent or legal guardian voluntarily joins the clinical study, CAR-T technique can be used for related treatment, and the long-term therapeutic effect can be observed. In this trial, 50 children were publicly enrolled and treated with CAR-T. Patients participating in the clinical trial will be tested and assessed in terms of treatment safety, efficacy, and duration of response.

02

Conditions studied

  • Childhood Acute Lymphoblastic Leukemia
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 637 are open to participants now.

This study's planned enrollment of 50 is above the median of 38 across 4,248 interventional studies indexed under Leukemia.

Browse Leukemia 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
1 Year to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. The treat history meeting the following criteria:

    Recurrence of lymphoma patients with imaging (CT/MRI/PET-CT) detection and pathological diagnosis, or recurrence including bone marrow morphology relapse and the MRD recurrence of myeloma patients or leukemia patients, after chemotherapy or stem cell transplantation; Can't get complete remission (including MRD positive) after more than twice repeated chemotherapy of incipient lymphoma, myeloma or leukemia patients; One or twice chemotherapy cannot get remission again (including MRD positive), but not suitable for chemotherapy of incipient lymphoma, myeloma or leukemia patients.

  2. There is a measurable lesions before treatment at least;
  3. ECOG score≤2;
  4. To be aged 1 to 18 years;
  5. More than a month lifetime from the consent signing date

Exclusion criteria

Exclusion Criteria:

  1. Serious cardiac insufficiency, left ventricular ejection fraction\<50%;
  2. Has a history of severe pulmonary function damaging;
  3. Merging other progressing malignant tumor;
  4. Merging uncontrolled infection;
  5. Merging the metabolic diseases (except diabetes);
  6. Merging severe autoimmune diseases or immunodeficiency disease;
  7. Patients with active hepatitis B or hepatitis C;
  8. Patients with HIV infection;
  9. Has a history of serious allergies on Biological products (including antibiotics);
  10. Has acute GvHD on allogeneic hematopoietic stem cell transplantation patients after stopping immunosuppressants a month;
  11. Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    volunteer

    The child's parents or legal guardians voluntarily signed the informed consent form, and the child himself/herself met the enter criteria for the diagnosis of patients with acute B-lymphoblastic leukemia (B-ALL) expressing specific target antigens

    Drug: CD19 CAR-T · Drug: CD22 CAR-T · Drug: CD 19+22 · Drug: Fludarabine · Drug: Cyclophosphamide

Interventions

  • DrugCD19 CAR-T

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

    Also known as: Senl_19

  • DrugCD22 CAR-T

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

    Also known as: Senl_22

  • DrugCD 19+22

    CD19+22 CAR-T infusion for pediatric patients with CD19 positive and CD22 positive tumor cells

    Also known as: Senl_19+22

  • DrugFludarabine

    25mg/㎡ for D-4、D-3 and D-2

    Also known as: flu

  • DrugCyclophosphamide

    500mg/㎡ for D-3 and D-2

    Also known as: ctx

06

What researchers measure

Primary outcomes

  1. Number of Participants with Severe/Adverse Events

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

    Time frame: 28 days

  2. CAR-T Cell expansion level

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

    Time frame: 24 months

Secondary outcomes

  1. Objective response rate of complete remission and partial remission

    Objective response rate of complete remission and partial remission

    Time frame: 24 months

  2. Overall survival time

    Overall survival time

    Time frame: 24 months

07

Study locations

1 of 1 sites recruiting
  • No.2 Hospital of Hebei Medical University
    Shijiazhuang, Hebei 050000, China
    • Jianqiang Li, PhD & MD · Contact · limmune@gmail.com · +86311-89928689
    • Jianmin Luo, PhD & MD · Contact · +86311-66002304
    • Jianmin Luo, PhD & MD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04626765
Lead sponsor
Hebei Senlang Biotechnology Inc., Ltd.
Collaborators
The Second Hospital of Hebei Medical University
Responsible party
Sponsor
First posted
Nov 13, 2020
Start date
Apr 1, 2020
Primary completion
Mar 30, 2023 (estimated)
Completion
May 30, 2023 (estimated)
Last update
Nov 13, 2020

Study contacts

Jianqiang Li, PhD&MD
Contact
limmune@gmail.com
+8631189928689
Jianmin Luo, PhD&MD
principal investigator · The Second Hospital of Hebei Medical University

Oversight

Data monitoring committee
No
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 Nov 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Leukemia→

Other studies from this sponsor

Hebei Senlang Biotechnology Inc., Ltd.

Start the discussion