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Childhood Acute Lymphoblastic LeukemiaEarly Phase 1NCT04626765

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

A Early Phase 1 study testing CD19 CAR-T, CD22 CAR-T and CD 19+22 in people with Childhood Acute Lymphoblastic Leukemia, run by Hebei Senlang Biotechnology Inc., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 more about this study

Who is it for?
Ages 1 year to 18 years
Conditions the study is for
Childhood Acute Lymphoblastic Leukemia
What is being tested?
CD19 CAR-T, CD22 CAR-T and CD 19+22
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
1 Apr 2020to 30 May 2023
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

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

Who cannot join

  • 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;
Show all 11Show fewer
  • 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;
  • Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.

Trial locations and contacts

1 site in 1 country.

Jianqiang Li, PhD&MD contact

+8631189928689

limmune@gmail.com

China1 site, 1 recruiting

  • No.2 Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000

    Jianqiang Li, PhD & MD, +86311-89928689, limmune@gmail.com

    Jianmin Luo, PhD & MD, +86311-66002304

    Recruiting

Other trials in China

About this study

Official title: An Open, Uncontrolled, Multicenter Clinical Trial to Explore the Safety, Efficacy, and Remission Phase of Chimeric Antigen Receptor T Cell (CAR-T) in the Treatment of Children With Relapsed and Refractory Acute Lymphoblastic Leukemia

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.

Being tested
CD19 CAR-T, CD22 CAR-T, CD 19+22, Fludarabine, Cyclophosphamide
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CD19 CAR-TDrug

    Also called Senl_19

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

  • CD22 CAR-TDrug

    Also called Senl_22

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

  • CD 19+22Drug

    Also called Senl_19+22

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

  • FludarabineDrug

    Also called flu

    25mg/㎡ for D-4、D-3 and D-2

  • CyclophosphamideDrug

    Also called ctx

    500mg/㎡ for D-3 and D-2

Study groups in NCT04626765
Study groupRoleWhat they receive
volunteerExperimentalThe 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
Receives: Drug: CD19 CAR-T; Drug: CD22 CAR-T; Drug: CD 19+22; Drug: Fludarabine; Drug: Cyclophosphamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Severe/Adverse Events

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

    Measured: 28 days

  2. CAR-T Cell expansion level

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

    Measured: 24 months

Secondary outcomes (2)

  1. Objective response rate of complete remission and partial remission

    Objective response rate of complete remission and partial remission

    Measured: 24 months

  2. Overall survival time

    Overall survival time

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2020
  2. Study start1 Apr 2020
  3. Primary completion30 Mar 2023 (estimated)
  4. Study completion30 May 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04626765
Sponsor's protocol ID
CAR-T for Childhood B-ALL
Status last verified
Nov 2020
First submitted
6 Nov 2020
Last updated
13 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing CD19 CAR-T, CD22 CAR-T and CD 19+22 in people with Childhood Acute Lymphoblastic Leukemia, run by Hebei Senlang Biotechnology Inc., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jianqiang Li, PhD&MD (+8631189928689, limmune@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Severe/Adverse Events (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04626765.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.

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