Acute Lymphoblastic LeukemiaPhase 1NCT04814004
Clinical Study of CAR-iNKT Cells in the Treatment of Relapsed/Refractory/High-risk B-cell Tumors
A Phase 1 study testing hCD19.IL15.CAR-iNKT in people with Acute Lymphoblastic Leukemia and B-cell Lymphoma, run by Kai Lin Xu; Jun Nian Zheng at 1 site in China.
Trial summary
This study aims to evaluate the safety and feasibility of hCD19.IL15.CAR-iNKT cells in treating patients with relapsed/refractory/high-risk B-cell tumors. Read more about this study
- Who is it for?
- Ages 5 to 70 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia, B-cell Lymphoma, Chronic Lymphocytic Leukemia
- What is being tested?
- hCD19.IL15.CAR-iNKT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 19 Mar 2021to 1 Apr 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 5 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female patients aged 5-70 years;
- The patient's ECOG score was ≤2, and the expected survival time of > was 12 weeks.
- The patient was diagnosed with B-cell tumor by pathological and histological examination and had no effective treatment options, such as recurrence after chemotherapy or hematopoietic stem cell transplantation. Or the patient voluntarily chooses the infusion of CAR-INKT cells as the first treatment.
- B cell tumors include the following three types:
- B-cell acute lymphocytic leukemia (B-ALL);
- Inert B-cell lymphoma (CLL, FL, MZL, LPL, HCL);
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- Aggressive B-cell lymphoma (DLBCL, BL, MCL);
- Subject:
- Residual lesions remain after primary treatment and are not suitable for HSCT (Auto/Allo-HSCT);
- relapse after complete response (CR1) and unsuitable for allogeneic/autologous HSCT;
- Patients with high risk factors;
- relapse or no remission after hematopoietic stem cell transplantation or cellular immunotherapy.
- having measurable or evaluable lesions;
- The main tissues and organs of the patient function well:
- Liver function: ALT/AST < 3 times the upper limit of normal (ULN);
- Renal function: creatinine < 220μmol/L;
- Lung function: indoor oxygen saturation ≥95%;
- Heart function: left ventricular ejection fraction (LVEF) ≥40%.
- Patients or their legal guardians voluntarily participate and sign the informed consent.
Who cannot join
- Pregnant or lactating women, or women who plan to become pregnant within six months;
- Infectious diseases (e.g. HIV, active hepatitis B or C infection, active tuberculosis, etc.);
- GVHD;
- Abnormal vital signs and failure to cooperate with the examination;
- People with mental or mental illness who are unable to cooperate with treatment and efficacy evaluation;
- People with high allergic constitution or severe allergic history, especially those allergic to IL-2;
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- Subjects with systemic infection or severe local infection need anti-infection therapy;
- Complicated with dysfunction of heart, lung, brain, liver, kidney and other important organs;
- Any unstable systemic disease: including but not limited to unstable angina pectoris, cerebrovascular accident or transient cerebral ischemia (within 6 months before screening), myocardial infarction (within 6 months before screening), congestive heart failure (NYHA classification ≥III);
- Doctors believe that there are other reasons for not being included in treatment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Affiliated hospital of Xuzhou medical University
Xuzhou, Jiangsu, 221000
Jiang Cao, M.D., Ph.D., 86-516-85802007, zimu05067@163.com
About this study
This study aims to evaluate the safety and feasibility of hCD19.IL15.CAR-iNKT cells in treating patients with relapsed/refractory/high-risk B-cell tumors.
Read the detailed description
CD19 CAR-T has been shown to treat a variety of refractory or recurrent B-cell tumors. Because most CAR-T cells are generated from the patient's own T cells and are individualized products, and there are individual differences between patients, the generation of customized CAR-T cells is an expensive and time-consuming process. Universal CAR- iNKT cells are an ideal product for cell therapy. In this study, we prepared universal iNKT cells expressing hCD19 CAR and IL-15 to treat refractory, relapsed, or high-risk B-cell tumors.
- Being tested
- hCD19.IL15.CAR-iNKT
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, B-Cell, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hCD19.IL15.CAR-iNKTDrug
Universal hCD19.IL15.CAR-iNKT cells by a single infusion intravenously will be given in escalating doses.
| Study group | Role | What they receive |
|---|---|---|
| hCD19.IL15.CAR-iNKT cells | Experimental | Dose escalation follows the accelerated titration and the standard 3+3 dose escalation design. A total of 3 dose levels are set for subjects. Receives: Drug: hCD19.IL15.CAR-iNKT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Measured: Baseline up to 28 days after T cell infusion
Secondary outcomes (4)
MRD negative overall response rate (MRD- ORR)
Assessment of MRD negative overall response rate (MRD- ORR) at 3 months of treatment
Measured: 3 months
Overall response rate (ORR)
Assessment of ORR (ORR = CR + CRi ) at Month 6, 12, 18 and 24
Measured: Month 6, 12, 18 and 24
Event-free survival (EFS)
Assessment of EFS at Month 6, 12, 18 and 24
Measured: Month 6, 12, 18 and 24
Overall survival (OS)
Assessment of OS at Month 6, 12, 18 and 24
Measured: Month 6, 12, 18 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start19 Mar 2021
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kai Lin Xu; Jun Nian Zheng
- Sponsor type
- University, hospital or other
- Collaborators
- Northern Jiangsu People's Hospital, The First People's Hospital of Changzhou, Nantong University, First Affiliated Hospital of Zhejiang University, Affiliated Hospital of Jiangsu University, Huai 'an First People's Hospital
- Responsible party
- Sponsor-investigator, Kai Lin Xu; Jun Nian Zheng, Xuzhou Medical University
- Investigators
- Kailin Xu, Ph.d, Study chair, The Affiliated Hospital of Xuzhou Medical UniversityJunnian Zheng, Ph.D, Study director, Xuzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04814004
- Sponsor's protocol ID
- XYFY2021-KL062
- Status last verified
- Mar 2021
- First submitted
- 22 Mar 2021
- Last updated
- 29 Mar 2021
- 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 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of CAR-iNKT Cells in the Treatment of Relapsed/Refractory/High-risk B-cell Tumors
- ClinicalTrials.gov ID
- NCT04814004
- Acronym / sponsor ID
- XYFY2021-KL062
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Kai Lin Xu; Jun Nian ZhengUniversity, hospital or other
- Collaborators
- Northern Jiangsu People's Hospital, The First People's Hospital of Changzhou, Nantong University, First Affiliated Hospital of Zhejiang University, Affiliated Hospital of Jiangsu University, Huai 'an First People's Hospital
- Study start
- 19 Mar 2021 (actual)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 24 Mar 2021 (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 aims to evaluate the safety and feasibility of hCD19.IL15.CAR-iNKT cells in treating patients with relapsed/refractory/high-risk B-cell tumors.
Detailed description
CD19 CAR-T has been shown to treat a variety of refractory or recurrent B-cell tumors. Because most CAR-T cells are generated from the patient's own T cells and are individualized products, and there are individual differences between patients, the generation of customized CAR-T cells is an expensive and time-consuming process. Universal CAR- iNKT cells are an ideal product for cell therapy. In this study, we prepared universal iNKT cells expressing hCD19 CAR and IL-15 to treat refractory, relapsed, or high-risk B-cell tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hCD19.IL15.CAR-iNKT cells | Experimental | Drug: hCD19.IL15.CAR-iNKTDose escalation follows the accelerated titration and the standard 3+3 dose escalation design. A total of 3 dose levels are set for subjects. |
Who may qualify
- Ages
- 5 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (19 listed)
- Male or female patients aged 5-70 years;
- The patient's ECOG score was ≤2, and the expected survival time of > was 12 weeks.
- The patient was diagnosed with B-cell tumor by pathological and histological examination and had no effective treatment options, such as recurrence after chemotherapy or hematopoietic stem cell transplantation. Or the patient voluntarily chooses the infusion of CAR-INKT cells as the first treatment.
- B cell tumors include the following three types:
- Subject:
Key exclusion criteria (10 listed)
- Pregnant or lactating women, or women who plan to become pregnant within six months;
- Infectious diseases (e.g. HIV, active hepatitis B or C infection, active tuberculosis, etc.);
- GVHD;
- Abnormal vital signs and failure to cooperate with the examination;
- People with mental or mental illness who are unable to cooperate with treatment and efficacy evaluation;
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 |
|---|---|---|
| hCD19.IL15.CAR-iNKTUniversal hCD19.IL15.CAR-iNKT cells by a single infusion intravenously will be given in escalating doses. | Drug | hCD19.IL15.CAR-iNKT cells |
Primary outcome
Dose-limiting toxicity
Time frame: Baseline up to 28 days after T cell infusion
Adverse events assessed according to NCI-CTCAE v5.0 criteria
4 secondary outcomes
MRD negative overall response rate (MRD- ORR)
Time frame: 3 months
Overall response rate (ORR)
Time frame: Month 6, 12, 18 and 24
Event-free survival (EFS)
Time frame: Month 6, 12, 18 and 24
Overall survival (OS)
Time frame: Month 6, 12, 18 and 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2021.
- 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. This study is not recruiting at the moment.
Kailin Xu, Ph.d study chair
The Affiliated Hospital of Xuzhou Medical University
Junnian Zheng, Ph.D study director
Xuzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing hCD19.IL15.CAR-iNKT in people with Acute Lymphoblastic Leukemia and B-cell Lymphoma, run by Kai Lin Xu; Jun Nian Zheng 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 19 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 29 Mar 2021. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiang Cao, Ph.D (86-516-85802007, zimu05067@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (time frame: Baseline up to 28 days after 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 29 Mar 2021.