Lymphoma, NonhodgkinPhase 2NCT06462248
Anti-CD19 Chimeric Antigen Receptor Modified T-cell (CAR-T) Therapy for Treatment of B-cell Hematological Malignancies
A Phase 2 study testing CUCART19 in people with Lymphoma, Nonhodgkin and Leukemia, Lymphocytic, run by Chi Kong Li at 1 site in China.
Trial summary
CAR-T therapy is now available as a commercial product for treatment of relapsed /refractory acute lymphoblastic leukaemia and B-lymphoma. There is limited access to this new treatment as the product is very expensive. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Lymphoma, Nonhodgkin, Leukemia, Lymphocytic
- What is being tested?
- CUCART19
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 31 Dec 2027
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Acute Lymphoblastic Leukaemia
- Paediatric or adult patients with relapsed or refractory CD19+ B cell ALL. (Age 0-60 years). Patients should be in first or subsequent relapse, or relapse after prior stem cell transplant, or persistent Minimal Residual Disease (MRD) positive disease
- ECOG performance score of ≤2 if >16 years old, or Lansky performance score of >50 if ≤16 years old at screening
- Post allogeneic stem cell transplant patients with B cell ALL will be eligible > 3 months after transplant and off immunosuppression for at least 1 month.
- Patients with active leukaemia who developed significant organ impairment that cannot tolerate conventional chemotherapy,
- For women of childbearing potential, a negative pregnancy test prior to apheresis
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- B-cell lymphoma
- Patients with histologically confirmed refractory Diffuse Large B-cell Lymphoma, primary mediastinal B cell lymphoma or transformed follicular lymphoma or other B-cell lymphoma according to WHO classification
- Confirmed CD19 positivity status in tissue sample obtained at diagnosis or relapse
- Received at least two prior treatment which must include at least one intensive systemic therapy.
- Disease progression or relapsed disease within 12 months after autologous stem cell transplant
- ECOG performance score of ≤2 if >16 years old, or Lansky performance score of >50 if ≤16 years old at screening
- Has sufficient organ function to tolerate treatment with CAR-T cell therapy
- For women of childbearing potential, a negative pregnancy test prior to apheresis
Who cannot join
- Patients with active infection
- Patients with B cell ALL post allogeneic transplant with active GVHD or on immunosuppression
- Recent donor lymphocyte infusion (DLI) after allogeneic transplant, less than 6 weeks between DLI and CAR T infusion
- Current autoimmune disease, or history of autoimmune disease with potential CNS involvement
- Active clinically significant CNS dysfunction (including but not limited to uncontrolled seizure disorders, cerebrovascular ischaemia or haemorrhage, dementia, paralysis)
- Patients who are positive for HBsAg, HCV RNA positive or with HIV infection
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- Pulmonary function: Grade 1 dyspnea and pulse oxygenation > 91% on room air
- Cardiac function: Fractional shortening <28% or left ventricular ejection fraction <45% by echocardiography.
- Renal function: Creatinine clearance <50 mL/min/1.73 m2
- Liver function: Patients with a serum bilirubin >3 times upper limit of normal or an AST or ALT > 5 times upper limit of normal, unless due to leukaemic liver infiltration in the estimation of the investigator
- Rapidly progressive disease that in the estimation of the investigator would compromise ability to complete study therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Hong Kong
Chi-Kong Li, MD, 852-3505-1019
About this study
Official title: A Single Arm, Open-labelled Phase II Clinical Trial of Anti-CD19 Chimeric Antigen Receptor Modified T-cell (CAR-T) for Treatment of B-cell Haematological Malignancies
CAR-T therapy is now available as a commercial product for treatment of relapsed /refractory acute lymphoblastic leukaemia and B-lymphoma. There is limited access to this new treatment as the product is very expensive. It is imperative to develop cost effective, closed circuit manufacturing systems for CAR-T cells to make CAR-T cells a point-of care production option. Hong Kong Institute of Biotechnology has established a certified GMP facility and utilize the Prodigy system to manufacture CAR-T cells for clinical application. Prince of Wales Hospital and Hong Kong Children's Hospital will conduct the phase II clinical trial to confirm the efficacy and safety of local manufactured CAR-T cell product.
Read the detailed description
This is a pilot study of CD19 specific CAR-T cells produced by the CliniMACS prodigy system in treatment of paediatric and adult with relapsed or refractory Acute Lymphoblastic Leukemia (ALL) or B cell Non-Hodgkin Lymphoma (NHL).
Our study aims to evaluate the safety and effectiveness of CD19 specific CAR-T cells produced by a closed circuit, point of care, manufacturing system to develop safe and effective CD19 specific CART cells for treatment of relapsed B cell NHL and relapsed refractory B cell ALL in children and adults. The CliniMACS plus system of Miltenyi Biotec is an automated cell separator with proven clinical efficacy. The CliniMACS prodigy system has been successfully used to generate a CD19 CAR T using lentiviral transduction with good efficiency of transduction and the activity of the CAR T cells.
This pilot study using anti-CD19 CAR-T cells generated by the CliniMACS prodigy system will be undertaken in the Prince of Wales Hospital under the Department of Clinical Oncology, Department of Medicine, and the Department of Anatomical \& Cellular Pathology. Children will be managed at Hong Kong Children's Hospital. The subjects will comprise of paediatric and adult B cell ALL patients and cohort B of paediatric and adult B cell NHL patients.
Eligible patients will go through Lymphapheresis procedures through central venous access. The cells will then be transferred to the CliniMACS prodigy system where they will be enriched and activated using the transAct CD3/CD28 Kit and transduced with a self-inactivating lentiviral vector encoding a CAR specific for CD19. The cells will be cultured, expanded and tested for efficiency of transduction, sterility and phenotype before preparation for patient use. The CAR-T cell treatment plan is consisted of a course of conditioning chemotherapy, followed by a single infusion of anti-CD19 CAR T cells after completion of conditioning / lymphodepletion chemotherapy. Patients will be observed as an inpatient for 7 days post treatment. Clinical status and progress of the patients, vital signs, blood counts, and blood chemistries will be monitored during and after CAR-T cell therapy. Occurrence of adverse events and serious adverse events will be recorded and managed with standard guidelines. Patients should be regularly followed up for at least two years after CAR T therapy. It is preferably to have long term follow-up of the patients beyond two years to look for any late complications
- Conditions
- Lymphoma, Nonhodgkin, Leukemia, Lymphocytic
- Being tested
- CUCART19
- Keywords
- relapsed leukemia, relapsed B-cell lymphoma
- Medical subject headings
- Lymphoma, Non-Hodgkin, Leukemia, Lymphoid, Leukemia, Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CUCART19Drug
Also called anti-CD19 CAR-T
anti-CD19 chimeric antigen receptor modified T-cell (CAR-T)
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | Single arm open labelled phase 2 study Receives: Drug: CUCART19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Production efficiency of CAR-T cell manufacturing
At least 90% of patients enrolled should be able to achieve successful production of CAR T cells as deomonstrated by CAR-T cell proliferation and persisteance of CAR-T cells in recipients for at least one month after infusion
Measured: 18 months
Secondary outcomes (1)
survival outcome
Achieve a leukemia free survival at 3 months of 60% or higher, and overall survival of B cell ALL patients at 6 months of 50% or higher. Overall and progression free survival of patients with B cell NHL
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start1 Jun 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, NonhodgkinStudies 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
- Model description
- single arm prospective study
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chi Kong Li
- Sponsor type
- University, hospital or other
- Collaborators
- Hong Kong Children's Hospital
- Responsible party
- Sponsor-investigator, Chi Kong Li, Prince of Wales Hospital, Shatin, Hong Kong
- Investigators
- Chi Kong Li, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06462248
- Sponsor's protocol ID
- CU2022
- Status last verified
- Jun 2024
- First submitted
- 7 Jun 2024
- Last updated
- 17 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: other researchers may approach Principal investigator directly for information
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Open-labelled Phase II Clinical Trial of Anti-CD19 Chimeric Antigen Receptor Modified T-cell (CAR-T) for Treatment of B-cell Haematological Malignancies
- ClinicalTrials.gov ID
- NCT06462248
- Acronym / sponsor ID
- CU2022
- Conditions
- Lymphoma, Nonhodgkin, Leukemia, Lymphocytic
- Keywords
- relapsed leukemia, relapsed B-cell lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Chi Kong LiUniversity, hospital or other
- Collaborators
- Hong Kong Children's Hospital
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Jun 2024 (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.
CAR-T therapy is now available as a commercial product for treatment of relapsed /refractory acute lymphoblastic leukaemia and B-lymphoma. There is limited access to this new treatment as the product is very expensive. It is imperative to develop cost effective, closed circuit manufacturing systems for CAR-T cells to make CAR-T cells a point-of care production option. Hong Kong Institute of Biotechnology has established a certified GMP facility and utilize the Prodigy system to manufacture CAR-T cells for clinical application. Prince of Wales Hospital and Hong Kong Children's Hospital will conduct the phase II clinical trial to confirm the efficacy and safety of local manufactured CAR-T cell product.
Detailed description
This is a pilot study of CD19 specific CAR-T cells produced by the CliniMACS prodigy system in treatment of paediatric and adult with relapsed or refractory Acute Lymphoblastic Leukemia (ALL) or B cell Non-Hodgkin Lymphoma (NHL).
Our study aims to evaluate the safety and effectiveness of CD19 specific CAR-T cells produced by a closed circuit, point of care, manufacturing system to develop safe and effective CD19 specific CART cells for treatment of relapsed B cell NHL and relapsed refractory B cell ALL in children and adults. The CliniMACS plus system of Miltenyi Biotec is an automated cell separator with proven clinical efficacy. The CliniMACS prodigy system has been successfully used to generate a CD19 CAR T using lentiviral transduction with good efficiency of transduction and the activity of the CAR T cells.
This pilot study using anti-CD19 CAR-T cells generated by the CliniMACS prodigy system will be undertaken in the Prince of Wales Hospital under the Department of Clinical Oncology, Department of Medicine, and the Department of Anatomical \& Cellular Pathology. Children will be managed at Hong Kong Children's Hospital. The subjects will comprise of paediatric and adult B cell ALL patients and cohort B of paediatric and adult B cell NHL patients.
Eligible patients will go through Lymphapheresis procedures through central venous access. The cells will then be transferred to the CliniMACS prodigy system where they will be enriched and activated using the transAct CD3/CD28 Kit and transduced with a self-inactivating lentiviral vector encoding a CAR specific for CD19. The cells will be cultured, expanded and tested for efficiency of transduction, sterility and phenotype before preparation for patient use. The CAR-T cell treatment plan is consisted of a course of conditioning chemotherapy, followed by a single infusion of anti-CD19 CAR T cells after completion of conditioning / lymphodepletion chemotherapy. Patients will be observed as an inpatient for 7 days post treatment. Clinical status and progress of the patients, vital signs, blood counts, and blood chemistries will be monitored during and after CAR-T cell therapy. Occurrence of adverse events and serious adverse events will be recorded and managed with standard guidelines. Patients should be regularly followed up for at least two years after CAR T therapy. It is preferably to have long term follow-up of the patients beyond two years to look for any late complications
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single arm prospective study
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Drug: CUCART19Single arm open labelled phase 2 study |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- Acute Lymphoblastic Leukaemia
- Paediatric or adult patients with relapsed or refractory CD19+ B cell ALL. (Age 0-60 years). Patients should be in first or subsequent relapse, or relapse after prior stem cell transplant, or persistent Minimal Residual Disease (MRD) positive disease
- ECOG performance score of ≤2 if >16 years old, or Lansky performance score of >50 if ≤16 years old at screening
- Post allogeneic stem cell transplant patients with B cell ALL will be eligible > 3 months after transplant and off immunosuppression for at least 1 month.
- Patients with active leukaemia who developed significant organ impairment that cannot tolerate conventional chemotherapy,
Key exclusion criteria (11 listed)
- Patients with active infection
- Patients with B cell ALL post allogeneic transplant with active GVHD or on immunosuppression
- Recent donor lymphocyte infusion (DLI) after allogeneic transplant, less than 6 weeks between DLI and CAR T infusion
- Current autoimmune disease, or history of autoimmune disease with potential CNS involvement
- Active clinically significant CNS dysfunction (including but not limited to uncontrolled seizure disorders, cerebrovascular ischaemia or haemorrhage, dementia, paralysis)
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 |
|---|---|---|
| CUCART19Also: anti-CD19 CAR-Tanti-CD19 chimeric antigen receptor modified T-cell (CAR-T) | Drug | single arm |
Primary outcome
Production efficiency of CAR-T cell manufacturing
Time frame: 18 months
At least 90% of patients enrolled should be able to achieve successful production of CAR T cells as deomonstrated by CAR-T cell proliferation and persisteance of CAR-T cells in recipients for at least one month after infusion
1 secondary outcome
survival outcome
Time frame: 24 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 17 Jun 2024.
- Individual participant dataSharing planned: No. other researchers may approach Principal investigator directly for information
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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.
Chi Kong Li, MD principal investigator
Chinese 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 Phase 2 study testing CUCART19 in people with Lymphoma, Nonhodgkin and Leukemia, Lymphocytic, run by Chi Kong Li at 1 site in China.
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 11 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 17 Jun 2024. 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 China. 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 Chi Kong Li, MD (852-35051019, ckli@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Production efficiency of CAR-T cell manufacturing (time frame: 18 months). 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 17 Jun 2024.