Lymphoma, B-CellNCT06866873
CD-19 CAR-T Cell for Pediatric ALL or Lymphoma
A study testing CAR-T in people with Lymphoma, B-Cell and Acute Lymphoblastic Leukemia, Pediatric, run by Hong Kong Children's Hospital at 1 site in Hong Kong.
Trial summary
This study seeks to examine the efficacy and safety of the administration of autologous T cells that have been modified through the introduction of a chimeric antigen receptor (CAR) targeting the B cell surface antigen CD19 following administration of chemotherapy lymphodepletion regimen in children with relapsed or… Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Lymphoma, B-Cell, Acute Lymphoblastic Leukemia, Pediatric
- What is being tested?
- CAR-T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 May 2024to 31 Dec 2037
- Phase
- Interventional
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects must have relapsed or refractory ALL or lymphoma treated with at least two lines of therapy. Disease must have either progressed after the last regimen or presented failure to achieve partial or complete remission with the last regimen.
- The patient's disease must be CD19 positive, either by immunohistochemistry or flow cytometry analysis on the last biopsy available.
- Age 1-17 years.
- Performance status: Subjects > 10 years of age: Karnofsky ≥ 50%; Subjects ≤ 10 years of age: Lansky scale ≥ 50%.
- Normal organ function.
- Total bilirubin ≤ 3 times upper limit of normal
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- AST (SGOT) ≤ 5 times upper limit of normal
- ALT (SGPT) ≤ 5 times upper limit of normal
- Serum Creatinine ≤ 2 times upper limit of normal
- Subjects must have the following hematologic function parameters: Hemoglobin (Hb) level > 8 g/dL; Absolute Lymphocyte Count > 0.1x10^9/L; Platelet > 50x10^9/L
- Prior therapy wash-out. At least 2 weeks or 5 half lives, whichever is shorter, must have elapsed since any prior systemic therapy at the time the subject is planned for leukapheresis.
- Subjects' parent or legal guardian must have the ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Autologous transplant within 6 weeks of planned CAR T cell infusion.
- Recipient of CAR-T cell therapy outside of this protocol.
- Active central nervous system (CNS) or meningeal involvement by tumor.
- History of additional active malignancy other than non-melanoma skin cancer, carcinoma in situ (e.g. cervix, bladder, breast).
- Active human immunodeficiency virus (HIV) infection.
- Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, pulmonary abnormalities or psychiatric illness/social situations that would limit compliance with study requirements.
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- Pregnant or breastfeeding women.
- Evidence of myelodysplasia or cytogenetic abnormality indicative of myelodysplasia on any bone marrow biopsy prior to initiation of therapy.
- Serologic status reflecting active hepatitis B or C infection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Hong Kong Children's Hospital
Hong Kong
Daniel Cheuk, MBBS, 852-35136049, cheukkld@ha.org.hk
About this study
Official title: Safety and Feasibility Study of CD19 Chimeric Antigen Receptor (CAR) T Cells in Children with Relapsed or Refractory CD19 Positive Acute Lymphoblastic Leukemia or Lymphoma
This study seeks to examine the efficacy and safety of the administration of autologous T cells that have been modified through the introduction of a chimeric antigen receptor (CAR) targeting the B cell surface antigen CD19 following administration of chemotherapy lymphodepletion regimen in children with relapsed or refractory acute lymphoblastic leukemia (ALL) or lymphoma. The overall goal of this study is to validate the safety profile of administration CD19-CAR T cells and describe the response rate in children with relapsed/refractory ALL or lymphoma.
- Being tested
- CAR-T
- Keywords
- CAR-T cell, Pediatric
- Medical subject headings
- Lymphoma, B-Cell, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR-TBiological
CAR-T cell (CHXCART01) infusion intravenously once at a dose of 0.2-2 million cells/kg recipient body weight
| Study group | Role | What they receive |
|---|---|---|
| CAR-T cell therapy | Experimental | CAR-T cell infusion intravenously once Receives: Biological: CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate (CRR) for ALL and Overall response rate (ORR) for lymphoma
Complete response for ALL was defined as leukemic cells <5% in bone marrow. Overall response for lymphoma was defined as complete response plus partial response defined by Lugano criteria.
Measured: 1 month for subjects with ALL, and 3 months for subjects with lymphoma
Incidence and severity of adverse events
Severity of adverse events are graded according to CTCAEv5.0.
Measured: through study completion, an average of 6 months
Secondary outcomes (4)
Frequency of minimal residual disease for ALL
Measurable residual disease in bone marrow by flow cytometry or PCR methods.
Measured: 1 month
Overall survival
survival as estimated by Kaplan-Meier method. Death from any cause is considered as event for analysis.
Measured: 1 year
Event-free survival
Event-free survival as estimated by Kaplan-Meier method. Events are death from any cause, or relapse or progression of underlying disease.
Measured: 1 year
Proportion of products successfully manufactured
Success defined as meeting product release criteria with at least 0.2 million cells/kg recipient body weight
Measured: at the time of 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 posted10 Mar 2025
- Study start1 May 2024
- Primary completion31 Dec 2037 (estimated)
- Study completion31 Dec 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, B-CellStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hong Kong Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheuk Ka Leung Daniel, Hong Kong Children's Hospital
- Investigators
- Pamela Lee, MD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06866873
- Sponsor's protocol ID
- HKCH-REC-2021-032
- Status last verified
- Mar 2025
- First submitted
- 3 Mar 2025
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility Study of CD19 Chimeric Antigen Receptor (CAR) T Cells in Children with Relapsed or Refractory CD19 Positive Acute Lymphoblastic Leukemia or Lymphoma
- ClinicalTrials.gov ID
- NCT06866873
- Acronym / sponsor ID
- HKCH-REC-2021-032
- Keywords
- CAR-T cell, Pediatric
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Hong Kong Children's HospitalUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Dec 2037 (estimated)
- Study completion
- 31 Dec 2037 (estimated)
- First posted
- 10 Mar 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.
This study seeks to examine the efficacy and safety of the administration of autologous T cells that have been modified through the introduction of a chimeric antigen receptor (CAR) targeting the B cell surface antigen CD19 following administration of chemotherapy lymphodepletion regimen in children with relapsed or refractory acute lymphoblastic leukemia (ALL) or lymphoma. The overall goal of this study is to validate the safety profile of administration CD19-CAR T cells and describe the response rate in children with relapsed/refractory ALL or lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAR-T cell therapy | Experimental | Biological: CAR-TCAR-T cell infusion intravenously once |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- Subjects must have relapsed or refractory ALL or lymphoma treated with at least two lines of therapy. Disease must have either progressed after the last regimen or presented failure to achieve partial or complete remission with the last regimen.
- The patient's disease must be CD19 positive, either by immunohistochemistry or flow cytometry analysis on the last biopsy available.
- Age 1-17 years.
- Performance status: Subjects > 10 years of age: Karnofsky ≥ 50%; Subjects ≤ 10 years of age: Lansky scale ≥ 50%.
- Normal organ function.
Key exclusion criteria (9 listed)
- Autologous transplant within 6 weeks of planned CAR T cell infusion.
- Recipient of CAR-T cell therapy outside of this protocol.
- Active central nervous system (CNS) or meningeal involvement by tumor.
- History of additional active malignancy other than non-melanoma skin cancer, carcinoma in situ (e.g. cervix, bladder, breast).
- Active human immunodeficiency virus (HIV) infection.
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 |
|---|---|---|
| CAR-TCAR-T cell (CHXCART01) infusion intravenously once at a dose of 0.2-2 million cells/kg recipient body weight | Biological | CAR-T cell therapy |
Primary outcome
Complete response rate (CRR) for ALL and Overall response rate (ORR) for lymphoma
Time frame: 1 month for subjects with ALL, and 3 months for subjects with lymphoma
Complete response for ALL was defined as leukemic cells <5% in bone marrow. Overall response for lymphoma was defined as complete response plus partial response defined by Lugano criteria.
Incidence and severity of adverse events
Time frame: through study completion, an average of 6 months
Severity of adverse events are graded according to CTCAEv5.0.
4 secondary outcomes
Frequency of minimal residual disease for ALL
Time frame: 1 month
Overall survival
Time frame: 1 year
Event-free survival
Time frame: 1 year
Proportion of products successfully manufactured
Time frame: at the time of 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 10 Mar 2025.
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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.
Pamela Lee, MD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAR-T in people with Lymphoma, B-Cell and Acute Lymphoblastic Leukemia, Pediatric, run by Hong Kong Children's Hospital at 1 site in Hong Kong.
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 12 inclusion and 9 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 10 Mar 2025. 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 Hong Kong. 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.
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 Daniel Cheuk, MBBS (852-35136049, cheukkld@ha.org.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response rate (CRR) for ALL and Overall response rate (ORR) for lymphoma (time frame: 1 month for subjects with ALL, and 3 months for subjects with lymphoma). 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?
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 10 Mar 2025.