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

NCT04626765 | Unknown Early Phase 1

• 1 other identifier: CAR-T for Childhood B-ALL
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Childhood Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Severe/Adverse Events

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

  28 days

• CAR-T Cell expansion level

  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)

volunteer

EXPERIMENTAL

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

CD19 CAR-T DRUG

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

Also known as: Senl_19

volunteer

CD22 CAR-T DRUG

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

Also known as: Senl_22

volunteer

CD 19+22 DRUG

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

Also known as: Senl_19+22

volunteer

Fludarabine DRUG

25mg/㎡ for D-4、D-3 and D-2

Also known as: flu

volunteer

Cyclophosphamide DRUG

500mg/㎡ for D-3 and D-2

Also known as: ctx

volunteer

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

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

Sponsors & Collaborators

• Hebei Senlang Biotechnology Inc., Ltd.: lead
• The Second Hospital of Hebei Medical University: collaborator

Study Sites (1)

No.2 Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

fludarabine; Influenza Vaccines; Cyclophosphamide; Cholestanetriol 26-Monooxygenase

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Cytochrome P450 Family 27; Cytochrome P-450 Enzyme System; Cytochromes; Enzymes and Coenzymes; Steroid Hydroxylases; Mixed Function Oxygenases; Oxygenases; Oxidoreductases; Enzymes; Hemeproteins; Proteins; Amino 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

+8631189928689; limmune@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: March 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)