Relapsed/Refractory B- Cell Non-Hodgkin LymphomaPhase 2CAR-T for NHLNCT06698484
To Evaluate Safety and Efficacy of Autologous CD19 Chimeric Antigen Receptor (CAR)-T Cells in Relapsed/Refractory B- Non-Hodgkin Lymphoma (B-NHL)
A Phase 2 study testing CAR-T cells in people with Relapsed/Refractory B- Cell Non-Hodgkin Lymphoma, run by National University of Malaysia at 1 site in Malaysia.
Trial summary
A Phase II Open-Label Single-arm Study to Evaluate Safety and Efficacy of locally manufactured autologous CD19-directed CAR T-cells in Patients with Relapsed/Refractory B- Non-Hodgkin Lymphoma (B-NHL) or patients not eligible for hematopoietic stem cell transplantation (HCT) Read more about this study
- Who is it for?
- Ages 13 to 75 years
- Conditions the study is for
- Relapsed/Refractory B- Cell Non-Hodgkin Lymphoma
- What is being tested?
- CAR-T cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteMalaysia
- Study dates
- 3 Jun 2021to 2 Jun 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 13 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with histologically confirmed diagnosed with CD19 positive B cell NHL in accordance with WHO classification
- Patients who are refractory to second-line treatment or patients who relapsed after first-line treatment with no available curative options such as autologous or allogeneic haematopoietic stem cell transplantation (HSCT) or relapse within one year of autologous HSCT
- At least one measurable lesion according to revised IWG response criteria
- Age between ≥13to ≤75 years
- Adequate organ function as defined by a creatinine clearance >40 ml/min, serum alanine transaminase (ALT) < 5 times the normal value, serum bilirubin < 3 times the normal value, left ventricular ejection fraction> 45%
- Absolute neutrophil count ≥ 1500/μl, haemoglobin level ≥ 7 g/dl, platelets ≥ 50000/μl.
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- Life expectancy >12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Female of childbearing age must have a negative pregnancy test and is on two effective contraception methods
- Male patients must use two effective contraception methods
Who cannot join
- Active central nervous system (CNS) lymphoma (detected by Imaging study or cerebrospinal fluid (CSF) analysis)
- Active cancer(other than NHL) or receiving cancer treatment
- Evidence of severe lung, heart (New York Heart Association class III/IV, arrhythmia, heart block, uncontrolled hypertension), liver, or renal failure or severe neurologic disorder
- Presence of active autoimmune disease requiring immunosuppressive therapy
- Human Immunodeficiency Virus (HIV) positivity
- Active Hepatitis B, and Hepatitis C infection
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- Uncontrolled infection
- Pregnant/nursing female.
- Receiving autologous or allogeneic stem cell transplant within 12 weeks of enrolment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site, 1 recruiting
- Recruiting
Universiti Kebangsaan Malaysia
Bandar Tun Razak, Kuala Lumpur
S Fadilah Abdul Wahid Dr., +60391456450, sfadilah@hctm.ukm.edu.my
S Fadilah Abdul Wahid Dr
About this study
Official title: A Phase II Open Label Single-arm Study to Evaluate Safety and Efficacy of Autologous CD19 CAR-T Cells in Patients With Relapsed/Refractory B- Non-Hodgkin Lymphoma
A Phase II Open-Label Single-arm Study to Evaluate Safety and Efficacy of locally manufactured autologous CD19-directed CAR T-cells in Patients with Relapsed/Refractory B- Non-Hodgkin Lymphoma (B-NHL) or patients not eligible for hematopoietic stem cell transplantation (HCT)
- Being tested
- CAR-T cells
- Keywords
- RR B- NHL, CD19 CAR-T cells, malaysia
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR-T cellsDrug
2×10^6 CAR T cells/kg
| Study group | Role | What they receive |
|---|---|---|
| Patient will infuse with autologous CD19 CAR-T cells | Experimental | CD19 CAR-T cells Receives: Drug: CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR)
The ORR is the sum of patients achieving complete response (CR) and partial response (PR) at day 30, then 3 monthly up to 24 months after receiving CAR T-cells determined by the investigator following Lugano criteria in non-Hodgkin Lymphoma (NHL).
Response assessment will be determined using a PET CT scan, or other relevant imaging studies and compared to the baseline (pre-CAR-T infusion) study.
Measured: From day 30, then 3 monthly until 24 months after infusion of CAR-T cells
Secondary outcomes (2)
overall survival
Overall survival (OS) is defined as the time from the date of CAR-T cell infusion to the date of death from any cause. Patients who are still alive will be censored at the date of last contact.
Measured: OS at day 30, 6 months and one year, and 2 years following CAR-T cells infusion
Incidence of adverse events
Cumulative incidence of CAR-T cell treatment-related adverse events (AEs) graded by ASCT consensus grading criteria for cytokine release syndrome (CRS) and Immune Effector cell-associated Neurotoxicity Syndrome (ICANS) and by common terminology criteria adverse events (CTCAE) versions 5.0 for other AEs in p[articular hematotoxicity and infection.
Measured: From the time of infusion up to 24 months after infusion of CAR-T cells
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start3 Jun 2021
- Primary completion2 Jun 2025 (estimated)
- Study completion2 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory B- Cell Non-Hodgkin LymphomaStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Plutonet Sdn Bhd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06698484
- Sponsor's protocol ID
- CAR-T NHL PTS Plutonet 2021
- Other IDs
- JEP-2021-224
- Acronym
- CAR-T for NHL
- Status last verified
- Nov 2024
- First submitted
- 10 Nov 2024
- Last updated
- 21 Nov 2024
- 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 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Open Label Single-arm Study to Evaluate Safety and Efficacy of Autologous CD19 CAR-T Cells in Patients With Relapsed/Refractory B- Non-Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT06698484
- Acronym / sponsor ID
- CAR-T for NHL / CAR-T NHL PTS Plutonet 2021
- Keywords
- RR B- NHL, CD19 CAR-T cells, malaysia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Collaborators
- Plutonet Sdn Bhd
- Study start
- 3 Jun 2021 (actual)
- Primary completion
- 2 Jun 2025 (estimated)
- Study completion
- 2 Jun 2026 (estimated)
- First posted
- 21 Nov 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.
A Phase II Open-Label Single-arm Study to Evaluate Safety and Efficacy of locally manufactured autologous CD19-directed CAR T-cells in Patients with Relapsed/Refractory B- Non-Hodgkin Lymphoma (B-NHL) or patients not eligible for hematopoietic stem cell transplantation (HCT)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient will infuse with autologous CD19 CAR-T cells | Experimental | Drug: CAR-T cellsCD19 CAR-T cells |
Who may qualify
- Ages
- 13 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with histologically confirmed diagnosed with CD19 positive B cell NHL in accordance with WHO classification
- Patients who are refractory to second-line treatment or patients who relapsed after first-line treatment with no available curative options such as autologous or allogeneic haematopoietic stem cell transplantation (HSCT) or relapse within one year of autologous HSCT
- At least one measurable lesion according to revised IWG response criteria
- Age between ≥13to ≤75 years
- Adequate organ function as defined by a creatinine clearance >40 ml/min, serum alanine transaminase (ALT) < 5 times the normal value, serum bilirubin < 3 times the normal value, left ventricular ejection fraction> 45%
Key exclusion criteria (9 listed)
- Active central nervous system (CNS) lymphoma (detected by Imaging study or cerebrospinal fluid (CSF) analysis)
- Active cancer(other than NHL) or receiving cancer treatment
- Evidence of severe lung, heart (New York Heart Association class III/IV, arrhythmia, heart block, uncontrolled hypertension), liver, or renal failure or severe neurologic disorder
- Presence of active autoimmune disease requiring immunosuppressive therapy
- Human Immunodeficiency Virus (HIV) positivity
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-T cells2×10^6 CAR T cells/kg | Drug | Patient will infuse with autologous CD19 CAR-T cells |
Primary outcome
Overall response rate (ORR)
Time frame: From day 30, then 3 monthly until 24 months after infusion of CAR-T cells
The ORR is the sum of patients achieving complete response (CR) and partial response (PR) at day 30, then 3 monthly up to 24 months after receiving CAR T-cells determined by the investigator following Lugano criteria in non-Hodgkin Lymphoma (NHL). Response assessment will be determined using a PET CT scan, or other relevant imaging studies and compared to the baseline (pre-CAR-T infusion) study.
2 secondary outcomes
overall survival
Time frame: OS at day 30, 6 months and one year, and 2 years following CAR-T cells infusion
Incidence of adverse events
Time frame: From the time of infusion up to 24 months after infusion of CAR-T cells
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 21 Nov 2024.
- Individual participant dataSharing planned: No
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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.
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 CAR-T cells in people with Relapsed/Refractory B- Cell Non-Hodgkin Lymphoma, run by National University of Malaysia at 1 site in Malaysia.
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 10 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 21 Nov 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 Malaysia. 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 S Fadilah Abdul Wahid Dr. (+60391456450, sfadilah@hctm.ukm.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) (time frame: From day 30, then 3 monthly until 24 months after infusion of CAR-T cells). 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 21 Nov 2024.