Relapse B Acute Lymphoblastic LeukemiaPhase 1CMD63NCT07078929
Clinical Trial of CMD63 Chimeric Antigen Receptor T-cell (CAR T-cell) in Children With Acute Lymphoblastic Leukemia (ALL)
A Phase 1 study testing CD19-IL7Ra CAR-T cells in people with Relapse B Acute Lymphoblastic Leukemia and Refactory Childhood Acute Lymphoblastic Leukemia, run by Chulalongkorn University at 3 sites in Thailand.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Relapse B Acute Lymphoblastic Leukemia, Refactory Childhood Acute Lymphoblastic Leukemia
- What is being tested?
- CD19-IL7Ra CAR-T cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 3 sitesThailand
- Study dates
- 1 Jan 2026to 1 Sep 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- 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.
- Participant with Philadelphia Chromosome positive ALL are eligible if the progressed, had stable disease or relapsed after one line of therapy including tyrosine kinase inhibitors (TKIs)
- 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
Show all 14Show fewer
- 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 antitumor antibody therapy 7.3 At least 30 days from most recent cellular infusion 7.4 All systemically administered corticosteroid treatment therapy must be stable or decreasing within 1 week prior to enrollment with a maximum of 0.5 mg/day dose of methylprednisolone. Corticosteroid physiologic replacement therapy is allowed
- Participants and/or care givers must have the ability to understand and willingness to sign a written informed consent document
Who cannot join
- 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.
- 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 enrollment.
- Participants who have a history of anaphylactic reaction to albumin.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand3 sites, 3 recruiting
- Not yet recruiting
Siriraj Hospital
Bangkok, Bangkoknoi, 10700
Kamon Phuakpet, Associate Professor, MD, +66867938333, kphuakpet@gmail.com
Krittin Rattananont, MD, +66805897820, krittin.ball@gmail.com
- Recruiting
King Chulalongkorn Memorial Hospital
Bangkok, Pathumwan, 10330
Kanhatai Chiengthong, MD, +66814430961, kanhatai.c@chula.ac.th
Piti Techavichit, Associate Professor, MD, +66817515363, piti.t@chula.ac.th
- Not yet recruiting
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, Mueang Chiang Mai District, 50200
Chane Choedamphai, Assistant Professor, MD, +66819943300, chane.c@cmu.ac.th
Chane Choedamphai, Assistant Professor, MD
About this study
Official title: Safety and Preliminary Efficacy of CD19 With IL-7 Receptor Alpha Signaling Chimeric Antigen Receptor T Cell (CMD63) in Relapse and Refractory Pediatric B-cell Acute Lymphoblastic Leukemia
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.
Read the detailed description
Hematological cancers are a significant public health problem in Thailand. Currently, treatment outcomes for patients with B-cell leukemia using standard chemotherapy regimens show satisfactory disease control and survival rates. However, patients with relapsed or refractory disease have very limited treatment options, as the chance of achieving remission through chemotherapy or targeted therapies before bone marrow transplantation is less than 20%. Once patients experience relapse or become refractory to treatment, their chance of surviving more than one year is extremely low. Therefore, developing new treatments for relapsed or refractory B-cell leukemia is urgently needed to provide additional treatment options, increase response rates, and improve survival outcomes in these patients.
Phase 1 to Phase 3 clinical research studies worldwide have demonstrated that treating patients with relapsed or refractory B-cell leukemia using the patients' own genetically modified T cells that specifically target B-cell leukemia and lymphoma cells can control the disease in 70-90% of B-cell leukemia patients. Approximately 50-60% of patients survive without disease recurrence for more than one year after treatment, with manageable side effects.
For these reasons, this research project aims to study the safety of treating Thai pediatric patients with relapsed or refractory B-cell leukemia using the patients' own T cells that have been genetically modified to become chimeric antigen receptor T cells specifically targeting proteins on the surface of leukemia cells. This research is being conducted for the first time in Thai pediatric patients. The research team expects this treatment to be highly safe and effective in controlling B-cell leukemia.
- Being tested
- CD19-IL7Ra CAR-T cells
- Keywords
- CAR T cell, CD19, IL-7 receptor alpha, Chimeric antigen receptor T cell, Adoptive cellular therapy, B-cell acute lymphoblastic leukemia
- Medical subject headings
- Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD19-IL7Ra CAR-T cellsBiological
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
| Study group | Role | What they receive |
|---|---|---|
| CD19 IL-7Ra CAR T cell in B-cell acute lymphoblastic leukemia | Experimental | CD19-specific chimeric antigen receptor (CAR) T cell with IL-7 receptor alpha signaling Dose level: 0.5x10e6 cells/kg, 1x10e6 cells/kg Receives: Biological: CD19-IL7Ra CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Measured: 30 days, 60 days, 90 days, 6 months and 12 months after CD19-IL7Ra CAR-T cell infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start1 Jan 2026
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapse B Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 3+3 dose escalation study
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Collaborators
- King Chulalongkorn Memorial Hospital
- Responsible party
- Sponsor
- Investigators
- Kanhatai Chiengthong, MD, Principal investigator, King Chulalongkorn Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07078929
- Sponsor's protocol ID
- CMD63-ALL-2025
- Other IDs
- Chulalongkorn University
- Acronym
- CMD63
- Status last verified
- Jul 2025
- First submitted
- 14 Jul 2025
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Preliminary Efficacy of CD19 With IL-7 Receptor Alpha Signaling Chimeric Antigen Receptor T Cell (CMD63) in Relapse and Refractory Pediatric B-cell Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT07078929
- Acronym / sponsor ID
- CMD63 / CMD63-ALL-2025
- Keywords
- CAR T cell, CD19, IL-7 receptor alpha, Chimeric antigen receptor T cell, Adoptive cellular therapy, B-cell acute lymphoblastic leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Collaborators
- King Chulalongkorn Memorial Hospital
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Hematological cancers are a significant public health problem in Thailand. Currently, treatment outcomes for patients with B-cell leukemia using standard chemotherapy regimens show satisfactory disease control and survival rates. However, patients with relapsed or refractory disease have very limited treatment options, as the chance of achieving remission through chemotherapy or targeted therapies before bone marrow transplantation is less than 20%. Once patients experience relapse or become refractory to treatment, their chance of surviving more than one year is extremely low. Therefore, developing new treatments for relapsed or refractory B-cell leukemia is urgently needed to provide additional treatment options, increase response rates, and improve survival outcomes in these patients.
Phase 1 to Phase 3 clinical research studies worldwide have demonstrated that treating patients with relapsed or refractory B-cell leukemia using the patients' own genetically modified T cells that specifically target B-cell leukemia and lymphoma cells can control the disease in 70-90% of B-cell leukemia patients. Approximately 50-60% of patients survive without disease recurrence for more than one year after treatment, with manageable side effects.
For these reasons, this research project aims to study the safety of treating Thai pediatric patients with relapsed or refractory B-cell leukemia using the patients' own T cells that have been genetically modified to become chimeric antigen receptor T cells specifically targeting proteins on the surface of leukemia cells. This research is being conducted for the first time in Thai pediatric patients. The research team expects this treatment to be highly safe and effective in controlling B-cell leukemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 3+3 dose escalation study
| Arm | Type | Receives |
|---|---|---|
| CD19 IL-7Ra CAR T cell in B-cell acute lymphoblastic leukemia | Experimental | Biological: CD19-IL7Ra CAR-T cellsCD19-specific chimeric antigen receptor (CAR) T cell with IL-7 receptor alpha signaling Dose level: 0.5x10e6 cells/kg, 1x10e6 cells/kg |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (14 listed)
- 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
- Performance status: Lansky or Karnofsky score greater than or equal to 50
Key exclusion criteria (7 listed)
- 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.
- Evidence of myelodysplasia or cytogenetic abnormality indicative of myelodysplasia on any bone marrow biopsy prior to initiation of therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CD19-IL7Ra CAR-T cellsAutologous 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 | Biological | CD19 IL-7Ra CAR T cell in B-cell acute lymphoblastic leukemia |
Primary outcome
Incidence and Severity of Adverse Events of CD19-IL7Ra CAR T-cells infusion in B-cell acute lymphoblastic leukemia patients.
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
The incidence of adverse events assessed by the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0
1 secondary outcome
The overall response rate of B-cell acute lymphoblastic leukemia
Time frame: 30 days, 60 days, 90 days, 6 months and 12 months after CD19-IL7Ra CAR-T cell infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Relapse B Acute Lymphoblastic Leukemia
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B-ALL, DLBCL
RecruitingPhase 1
A Phase I Dose Finding Study of MB-CART2219.1
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BLinatumomab and iNKT in Relapsed B-Cell ALL
B-Cell ALL, ALL (Acute B-Lymphoblastic Leukemia)
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In VIVO CAR-T Therapy for Relapsed/Refractory Hematological Malignancies
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Not yet recruitingPhase 2
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Acute Lymphobkastic Leukemia, Adult
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kanhatai Chiengthong, MD principal investigator
King Chulalongkorn Memorial Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CD19-IL7Ra CAR-T cells in people with Relapse B Acute Lymphoblastic Leukemia and Refactory Childhood Acute Lymphoblastic Leukemia, run by Chulalongkorn University at 3 sites in Thailand.
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 14 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Thailand. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Piti Techavichit, Associate Professor, MD (+66817515363, piti.t@chula.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Severity of Adverse Events of CD19-IL7Ra CAR T-cells infusion in B-cell acute lymphoblastic leukemia patients. (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Mar 2026.