Clinical Trial of CMD63 Chimeric Antigen Receptor T-cell (CAR T-cell) in Children With Acute Lymphoblastic Leukemia (ALL)

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age1-18
SponsorChulalongkorn University

About this trial

A Phase 1 clinical trial to evaluate the safety and early efficacy of Chimeric Antigen Receptor T-cell (CAR T-cell) with IL-7Rα signaling targeting CD19 in children with relapsed and refractory B-cell Acute Lymphoblastic Leukemia (ALL) after complete standard treatments.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants must have relapsed, or refractory ALL treated with at least one lines of therapy. Disease must have either progressed after the last regimen or presented failure to achieve complete remission with the last regimen.

The participant's disease must be CD19 positive either by immunohistochemistry or flow cytometry analysis

Age 1 - 18 years

Sex: Male or Female

Disqualifiers

Active GVHD that required systemic immunosuppressant with 4 weeks of enrollment

History of active malignancy other than non-melanoma skin cancer and carcinoma in situ (e.g. cervix, bladder, breast).

Participants with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, pulmonary abnormalities, Graft Versus Host Disease or psychiatric illness/social situations that would limit compliance with study requirements.

Pregnant or breastfeeding women are excluded from this study because CAR-T cell therapy may be associated with potential for teratogenic or abortifacient effect. Women of child bearing potential must have negative serum pregnancy test. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of mother with CAR-T cells, breast feeding should be discontinued. These potential risks may also apply to other agents used in this study. Participants of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study and for four months after receiving CAR-T cell infusion.

Trial design

Design model

Single group

Treatments tested in this trial

  • CD19-IL7Ra CAR-T cells

    Biological/Vaccine

    Autologous T cells lentiviral transduced to express a CD19-specific chimeric antigen receptor (CAR) with the addition of an IL-7 receptor alpha signaling domain, administered via central venous access catheter after lymphodepletion

Treatment groups

16 Participants
are divided into 1 treatment group
Group A: CD19 IL-7Ra CAR T cell in B-cell acute lymphoblastic leukemiaExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence and Severity of Adverse Events of CD19-IL7Ra CAR T-cells infusion in B-cell acute lymphoblastic leukemia patients.

The incidence of adverse events assessed by the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0

Time frame
7 days, 14 days, 21 days, 30 days, 60 days, 90 days, 6 months and 12 months after CD19-IL7Ra CAR-T cell infusion

Secondary outcomes

1

The overall response rate of B-cell acute lymphoblastic leukemia

The overall response rate will be assessed using standard response criteria for acute lymphoblastic leukemia patients through a combination of clinical, hematologic, and molecular assessments. The response categories are Minimal Residual Disease (MRD), Complete Response (CR), Complete Response with Incomplete Count Recovery (CRi), Stable Disease (SD), and Progressive Disease (PD).

Time frame
30 days, 60 days, 90 days, 6 months and 12 months after CD19-IL7Ra CAR-T cell infusion

Other outcomes

1

Persistence of anti-CD19 CAR-T cell in peripheral blood

Persistence of anti-CD19 CAR-T cell in peripheral blood of leukemia patients measuring by flow cytometry and qPCR.

Time frame
7 days, 14 days, 21 days, 30 days, 60 days, 90 days, 6 months and 12 months after CD19-IL7Ra CAR-T cell infusion
2

Serum cytokine level measurement

Serum cytokine level measurement including IL-2,IL-4, IL-6, IL-10, TNF-alpha and IFN-gamma before and after CD19-IL7Ra CAR T-cell infusion

Time frame
7 days, 14 days, 21 days and 30 days after CD19-IL7Ra CAR-T cell infusion

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chulalongkorn University

Lead sponsor

King Chulalongkorn Memorial Hospital

Collaborator