Lymphoblastic LeukemiaPhase 2NCT05648019
CD19-Directed Chimeric Antigen Receptor (CAR) T-Cell Therapy for Relapsed/Refractory B-Lineage Leukaemia / Lymphoma - A Feasibility Protocol
A Phase 2 study testing Anti-CD19 CAR T-cells in people with Lymphoblastic Leukemia and Lymphoblastic Leukemia in Children, run by KK Women's and Children's Hospital at 2 sites in Singapore.
Trial summary
The purpose of this study is to describe feasibility of delivering point-of-care manufactured CD19-directed CAR T-cell therapy to patients with relapsed/ refractory B-lineage leukaemia/ lymphoma. Read more about this study
- Who is it for?
- Ages 0 to 70 years
- Conditions the study is for
- Lymphoblastic Leukemia, Lymphoblastic Leukemia in Children, Lymphoblastic Leukemia, Acute Adult
- What is being tested?
- Anti-CD19 CAR T-cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesSingapore
- Study dates
- 15 Mar 2022to Dec 2026
- Phase
- Phase 2
- 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 0 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Eligible disease conditions:
- Relapsed or refractory B-cell ALL (all must be satisfied)
- Presence of lymphoblasts in bone marrow aspirate by morphologic assessment or positive minimal residual disease at screening.
- Relapsed or refractory or ineligible for HSCT
- For relapsed B-ALL: Documentation of CD19 tumour expression (e.g. by flow cytometry) demonstrated in bone marrow or peripheral blood within 3 months of study entry
- Relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.
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- Age at screening:
- < 18 years (paediatric group); or
- ≥ 18 years (adult group)
- Adequate organ functions:
- Life expectancy more than 12 weeks.
- Karnofsky (age ≥ 16 years) or Lansky (age < 16 years) performance status ≥ 50 at screening.
- Must meet the institutional criteria to undergo leukapheresis or have a leukapheresis product of non-mobilized cells received and accepted by the manufacturing site.
Who cannot join
- Patients with any of the following will be excluded:
- B-ALL with isolated extramedullary disease relapse
- Patients with concomitant genetic syndrome: such as patients with Fanconi anaemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome. Patients with Down syndrome will not be excluded.
- Patients with Burkitt's lymphoma/leukaemia (i.e. patients with mature B-cell ALL; leukaemia with B-cell [sIg positive and kappa or lambda restricted positivity] ALL, with FAB L3 morphology and /or a MYC translocation)
- Active or latent hepatitis B or active hepatitis C (test within 8 weeks of screening), or any uncontrolled infection at screening
- Human Immunodeficiency Virus (HIV) positive test within 8 weeks of screening
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- Presence of grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD)
- Active CNS involvement by malignancy, defined by CNS-3 per NCCN guidelines. Subjects with CNS-2 involvement or with history of CNS disease that have been actively treated are eligible.
- Patient has an investigational medicinal product within the last 30 days prior to screening.
- Pregnant or nursing women.
- Women of childbearing potential (defined as all women physiologically capable of becoming pregnant) and all male participants, unless they are using highly effective methods of contraception for a period of 1 year after the CAR T-cell infusion. All female patients of childbearing potential must have a negative pregnancy test performed within 48 hours before infusion of CAR T-cells.
- The following are not strictly exclusion criteria but must be discussed with PI/Site-PI:
- Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease
- Treatment with any prior gene therapy product
- Has had treatment with any prior anti-CD19/anti-CD3 therapy, or any other anti-CD19 therapy
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore2 sites, 2 recruiting
- Recruiting
Singapore General Hospital
Singapore, 169608
Aloysius Ho, MD
Aloysius Ho
- Recruiting
KK Women's and Children's Hospital
Singapore, 229899
Shui Yen Soh, +65 6394 1045, soh.shui.yen@singhealth.com.sg
Shui Yen Soh
About this study
The purpose of this study is to describe feasibility of delivering point-of-care manufactured CD19-directed CAR T-cell therapy to patients with relapsed/ refractory B-lineage leukaemia/ lymphoma.
Read the detailed description
This is a single arm, open-label, multi-center, phase II feasibility study to deliver point-of-care manufactured CD19-directed CAR T-cell therapy to patients with relapsed / refractory B-lineage leukaemia / lymphoma.
The study consists of the following phases:
- Screening phase: Eligibility; enrolment
- Preparatory phase: Bridging therapy (if required); leukapheresis; CAR T manufacturing; lymphodepletion.
- Treatment phase: Infusion of single dose of anti-CD19 CAR T-cells
- Follow-up Phase: Efficacy and safety monitoring up to 24 months
- Conditions
- Lymphoblastic Leukemia, Lymphoblastic Leukemia in Children, Lymphoblastic Leukemia, Acute Adult, B-cell Acute Lymphoblastic Leukemia, Large B-cell Lymphoma, CAR
- Being tested
- Anti-CD19 CAR T-cells
- Keywords
- CAR T-cell therapy, Relapse/Refractory, B-ALL, B-Lineage Lymphoma
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Burkitt Lymphoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-CD19 CAR T-cellsBiological
A target per-protocol dose of vi able CD19 CAR transduced T-cells will consist of a single infusion of 0.2 to 5.0 x 10e6 lentiviral-transduced viable 41BB-CD19 CAR T-cells per kg body weight.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | CD19-directed CAR T-cell therapy for relapsed/refractory B-lineage leukaemia/lymphoma. Receives: Biological: Anti-CD19 CAR T-cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protocol Feasibility
To describe feasibility of delivering point-of-care manufactured CD19-directed CAR T-cell therapy to patients with relapsed / refractory B-lineage leukaemia / lymphoma by assessing number and percentage of enrolled patients who have successful manufacturing of CAR T-cell product, and number and percentage of enrolled patients who go on to receive the CAR T-cell product.
Measured: 3 years
Secondary outcomes (2)
Overall Response Rate
To evaluate percentage of patients with complete response or partial response at 28 days, 3 months and 6 months post-infusion of the CD19-directed CAR T-cells.
Measured: 6 months
Toxicity Evaluations
To evaluate overall incidence (percentage of infused patients) of toxicities post-infusion of CAR T-cells, in particular cytokine release syndrome (CRS) and neurotoxicity, and percentage with Grade 3 and above CRS and neurotoxicity following ASTCT definition and severity grading, and other toxicities as assessed by CTCAE v5.0.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start15 Mar 2022
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoblastic LeukemiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Collaborators
- Singapore General Hospital
- Responsible party
- Sponsor
- Investigators
- Shui Yen Soh, MD, Principal investigator, KK Women's and Children's HospitalAloysius Ho, MD, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05648019
- Sponsor's protocol ID
- SHCELL18P1
- Status last verified
- Mar 2023
- First submitted
- 1 Aug 2022
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CD19-Directed Chimeric Antigen Receptor (CAR) T-Cell Therapy for Relapsed/Refractory B-Lineage Leukaemia / Lymphoma - A Feasibility Protocol
- ClinicalTrials.gov ID
- NCT05648019
- Acronym / sponsor ID
- SHCELL18P1
- Conditions
- Lymphoblastic Leukemia, Lymphoblastic Leukemia in Children, Lymphoblastic Leukemia, Acute Adult, B-cell Acute Lymphoblastic Leukemia, Large B-cell Lymphoma, CAR
- Keywords
- CAR T-cell therapy, Relapse/Refractory, B-ALL, B-Lineage Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Collaborators
- Singapore General Hospital
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 Dec 2022 (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.
The purpose of this study is to describe feasibility of delivering point-of-care manufactured CD19-directed CAR T-cell therapy to patients with relapsed/ refractory B-lineage leukaemia/ lymphoma.
Detailed description
This is a single arm, open-label, multi-center, phase II feasibility study to deliver point-of-care manufactured CD19-directed CAR T-cell therapy to patients with relapsed / refractory B-lineage leukaemia / lymphoma.
The study consists of the following phases:
- Screening phase: Eligibility; enrolment
- Preparatory phase: Bridging therapy (if required); leukapheresis; CAR T manufacturing; lymphodepletion.
- Treatment phase: Infusion of single dose of anti-CD19 CAR T-cells
- Follow-up Phase: Efficacy and safety monitoring up to 24 months
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Biological: Anti-CD19 CAR T-cellsCD19-directed CAR T-cell therapy for relapsed/refractory B-lineage leukaemia/lymphoma. |
Who may qualify
- Ages
- 0 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Eligible disease conditions:
- Age at screening:
- Adequate organ functions:
- Life expectancy more than 12 weeks.
- Karnofsky (age ≥ 16 years) or Lansky (age < 16 years) performance status ≥ 50 at screening.
Key exclusion criteria (15 listed)
- B-ALL with isolated extramedullary disease relapse
- Patients with concomitant genetic syndrome: such as patients with Fanconi anaemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome. Patients with Down syndrome will not be excluded.
- Patients with Burkitt's lymphoma/leukaemia (i.e. patients with mature B-cell ALL; leukaemia with B-cell [sIg positive and kappa or lambda restricted positivity] ALL, with FAB L3 morphology and /or a MYC translocation)
- Active or latent hepatitis B or active hepatitis C (test within 8 weeks of screening), or any uncontrolled infection at screening
- Human Immunodeficiency Virus (HIV) positive test within 8 weeks of screening
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 |
|---|---|---|
| Anti-CD19 CAR T-cellsA target per-protocol dose of vi able CD19 CAR transduced T-cells will consist of a single infusion of 0.2 to 5.0 x 10e6 lentiviral-transduced viable 41BB-CD19 CAR T-cells per kg body weight. | Biological | Single Arm |
Primary outcome
Protocol Feasibility
Time frame: 3 years
To describe feasibility of delivering point-of-care manufactured CD19-directed CAR T-cell therapy to patients with relapsed / refractory B-lineage leukaemia / lymphoma by assessing number and percentage of enrolled patients who have successful manufacturing of CAR T-cell product, and number and percentage of enrolled patients who go on to receive the CAR T-cell product.
2 secondary outcomes
Overall Response Rate
Time frame: 6 months
Toxicity Evaluations
Time frame: 6 months
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 9 Mar 2023.
- Individual participant dataSharing planned: Undecided
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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.
Shui Yen Soh, MD principal investigator
KK Women's and Children's Hospital
Aloysius Ho, MD principal investigator
Singapore General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anti-CD19 CAR T-cells in people with Lymphoblastic Leukemia and Lymphoblastic Leukemia in Children, run by KK Women's and Children's Hospital at 2 sites in Singapore.
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 13 inclusion and 15 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 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Shui Yen Soh, MD (+65 6394 1045, soh.shui.yen@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protocol Feasibility (time frame: 3 years). 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 9 Mar 2023.