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New treatment option for Relapse B Acute Lymphoblastic Leukemia
Official title Clinical Trial of CMD63 Chimeric Antigen Receptor T-cell (CAR T-cell) in Children With Acute Lymphoblastic Leukemia (ALL)
ClinicalTrials.gov ID: NCT07078929
What this study is testing
What is CD19-IL7Ra CAR-T cells?
CD19-IL7Ra CAR-T cells is an investigational medicine, being studied as a potential treatment for relapse b acute lymphoblastic leukemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 18
You may be able to join if
- Participants must have relapsed, or refractory ALL treated with at least one lines of therapy. Disease must have either progressed after the last...
- The participant's disease must be CD19 positive either by immunohistochemistry or flow cytometry analysis
- Age 1 - 18 years
- Sex: Male or Female
- Performance status: Lansky or Karnofsky score greater than or equal to 50
You likely can't join if
- 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...
- Pregnant or breastfeeding women are excluded from this study because CAR-T cell therapy may be associated with potential for teratogenic or...
- Evidence of myelodysplasia or cytogenetic abnormality indicative of myelodysplasia on any bone marrow biopsy prior to initiation of therapy.
- Serologic status reflecting active HIV, hepatitis B or C infection. Participants that are positive for hepatitis B core antibody, hepatitis B surface...
See the full eligibility criteria
- 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...
- The participant's disease must be CD19 positive either by immunohistochemistry or flow cytometry analysis
- Age 1 - 18 years
- Sex: Male or Female
- Performance status: Lansky or Karnofsky score greater than or equal to 50
- Normal organ function:
- AST (SGOT) less 5 times the upper limit of normal (ULN)
- ALT (SGPT) less 5 times the upper limit of normal (ULN)
- Total bilirubin less 3 times the upper limit of normal (ULN)
- Creatinine less 5 times the upper limit of normal (ULN)
- SpO2 room air greater than or equal to 90%
- Prior therapy wash-out before planned leukapheresis 7.1 Greater than or equal to 7 days post last chemotherapy/biologic therapy administration 7.2 Three half-lives or 30 days, whichever is shorter after the last dose of...
- Participants and/or care givers must have the ability to understand and willingness to sign a written informed consent document
- 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...
- 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...
- Evidence of myelodysplasia or cytogenetic abnormality indicative of myelodysplasia on any bone marrow biopsy prior to initiation of therapy.
- Serologic status reflecting active HIV, hepatitis B or C infection. Participants that are positive for hepatitis B core antibody, hepatitis B surface antigen or hepatitis C antibody must have negative PCR prior to...
- Participants who have a history of anaphylactic reaction to albumin.
The study team makes the final eligibility decision.
Where it's taking place
- Bangkok, Bangkoknoi, Thailand
- Chiang Mai, Mueang Chiang Mai District, Thailand
- Bangkok, Pathumwan, Thailand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bangkok, Bangkoknoi, Thailand; Chiang Mai, Mueang Chiang Mai District, Thailand; Bangkok, Pathumwan, Thailand. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.