Lymphoma, B-CellPhase 1/2NCT05651100
Safety and Efficacy of Sequential CD19 and CD22 Targeted CAR-T Therapy for Relapsed/Refractory B Cell Lymphoma
A Phase 1/2 study testing CD19 and CD22 targeted CAR-T cells in people with Lymphoma, B-Cell, run by Kecellitics Biotech Company Ltd at 1 site in China.
Trial summary
This is a single arm study to evaluate the efficacy and safety of Sequential CD19 and CD22 targeted CAR-T cells therapy for patients with relapsed/refractory B Cell Lymphoma. Read more about this study
- Who is it for?
- Ages 3 to 70 years
- Conditions the study is for
- Lymphoma, B-Cell
- What is being tested?
- CD19 and CD22 targeted CAR-T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 10 Dec 2022to 10 Dec 2025
- Phase
- Phase 1/2
- 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 3 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Relapsed or refractory B cell non-hodgkin lymphoma.
- KPS>60.
- Life expectancy>12 weeks.
- Gender unlimited, age from 3 years to 70 years.
- Evidence for cell membrane CD19 and/or CD22 expression;
- Patients who have failed at least one line of a standard treatment.
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- No serious mental disorder.
- Patients must have adequate cardiac function(no cardiac disease, LVEF≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of >94%, and adequate renal function(Cr≤133umol/L).
- No other serious diseases(autoimmune disease, immunodeficiency etc.).
- No other tumors.
- Patients volunteer to participate in the research.
- Patients with history of allogeneic stem cell transplantation are eligible if at least 100 days post-transplant, if there is no evidence of active GVHD and no longer taking immunosuppressive agents for at least 30 days prior to trial
Who cannot join
- Pregnancy and nursing females.
- Patients are allergic to cytokines.
- Uncontrolled active infection.
- Acute or chronic GVHD.
- Treated with T cell inhibitor.
- Patients who had used steroid hormones within one week.
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- Patients who had used Rituximab within two weeks.
- HIV/HBV/HCV Infection.
- Other situations we think improper for the research.
Trial locations and contacts
1 site in 1 country.
China1 site
Hebei Yanda Ludaopei Hospital
Langfang, Hebei, 065201
Li xiangqun, Doctor, 086-15712867910, xiangqun_li@doingtimes.com
About this study
Official title: Phase 1/Phase 2 Study of Sequential Chimeric Antigen Receptor T Cell Targeting at CD19 and CD22 B-cell Antigens Treating Refractory or Relapsed B-cell Lymphoma Patients
This is a single arm study to evaluate the efficacy and safety of Sequential CD19 and CD22 targeted CAR-T cells therapy for patients with relapsed/refractory B Cell Lymphoma.
Read the detailed description
Although the CD19 targeted CAR-T cell therapies have gained significant results in patients with relapsed and refractory B-cell Leukemia and Lymphoma. There are some patients who resisted anti-CD19 CAR-T cells or get CD19 negative relapse. To make further improvement, We launch such a clinical trial using sequential CD19 and CD22 targeted CAR-T cells for patients with relapsed and refractory B Cell Lymphoma to evaluate the efficacy and safety of sequential CD19 and CD22 targeted CAR-T cell therapy.
- Conditions
- Lymphoma, B-Cell
- Being tested
- CD19 and CD22 targeted CAR-T cells
- Keywords
- CAR-T, Lymphoma
- Medical subject headings
- Lymphoma, B-Cell, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD19 and CD22 targeted CAR-T cellsBiological
CAR-T cells were manufactured from peripheral blood mononuclear cells collected by leukapheresis and frozen for multiple uses. Before each CAR T-cell infusion (day 0), patients received lymphodepleting chemotherapy composing of Fludarabine (30 mg/m2/day) and Cyclophosphamide (300 mg/m2/day) on days -5 to -3. No bridging chemotherapy was given between enrollment and infusion. In sequential CAR-T clinical trials, CAR-T cells will be given.（anti-CD19 CAR-T first, then anti-CD22 CAR-T).
| Study group | Role | What they receive |
|---|---|---|
| arm 1 | Experimental | sequential CD19 and CD22 targeted CAR-T cells treat Receives: Biological: CD19 and CD22 targeted CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events that related to treatment
Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).
Measured: 1 years
Overall remission rate (ORR)
The ORR of Sequential CD19 and CD22 CAR-T treatment will be recorded and assessed according to the revised 2014 Lugano Criteria.
Measured: 3 months
Secondary outcomes (5)
complete response(CR)
The CR of Sequential CD19 and CD22 CAR-T treatment will be recorded and assessed according to the revised 2014 Lugano Criteria.
Measured: 24 months
partial response(PR)
The PR of Sequential CD19 and CD22 CAR-T treatment will be recorded and assessed according to the revised 2014 Lugano Criteria.
Measured: 24 months
stable disease(SD)
The SD of Sequential CD19 and CD22 CAR-T treatment will be recorded and assessed according to the revised 2014 Lugano Criteria.
Measured: 24 months
progressive disease(PD)
The PD of Sequential CD19 and CD22 CAR-T treatment will be recorded and assessed according to the revised 2014 Lugano Criteria.
Measured: 24 months
Duration of remission (DOR)
DOR will be assessed from the first assessment of CR/CRi to the first assessment of recurrence or progression of the disease or death from any cause.
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 posted14 Dec 2022
- Study start10 Dec 2022 (estimated)
- Primary completion10 Dec 2024 (estimated)
- Study completion10 Dec 2025 (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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kecellitics Biotech Company Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hebei Yanda Ludaopei Hospital
- Responsible party
- Sponsor
- Investigators
- li xiangqun, doctor, Study chair, Kecellitics Biotech Company Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05651100
- Sponsor's protocol ID
- Kece-4
- Status last verified
- Dec 2022
- First submitted
- 26 Nov 2022
- Last updated
- 14 Dec 2022
- 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 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/Phase 2 Study of Sequential Chimeric Antigen Receptor T Cell Targeting at CD19 and CD22 B-cell Antigens Treating Refractory or Relapsed B-cell Lymphoma Patients
- ClinicalTrials.gov ID
- NCT05651100
- Acronym / sponsor ID
- Kece-4
- Conditions
- Lymphoma, B-Cell
- Keywords
- CAR-T, Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kecellitics Biotech Company LtdIndustry (pharma, biotech, devices)
- Collaborators
- Hebei Yanda Ludaopei Hospital
- Study start
- 10 Dec 2022 (estimated)
- Primary completion
- 10 Dec 2024 (estimated)
- Study completion
- 10 Dec 2025 (estimated)
- First posted
- 14 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.
This is a single arm study to evaluate the efficacy and safety of Sequential CD19 and CD22 targeted CAR-T cells therapy for patients with relapsed/refractory B Cell Lymphoma.
Detailed description
Although the CD19 targeted CAR-T cell therapies have gained significant results in patients with relapsed and refractory B-cell Leukemia and Lymphoma. There are some patients who resisted anti-CD19 CAR-T cells or get CD19 negative relapse. To make further improvement, We launch such a clinical trial using sequential CD19 and CD22 targeted CAR-T cells for patients with relapsed and refractory B Cell Lymphoma to evaluate the efficacy and safety of sequential CD19 and CD22 targeted CAR-T cell therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| arm 1 | Experimental | Biological: CD19 and CD22 targeted CAR-T cellssequential CD19 and CD22 targeted CAR-T cells treat |
Who may qualify
- Ages
- 3 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Relapsed or refractory B cell non-hodgkin lymphoma.
- KPS>60.
- Life expectancy>12 weeks.
- Gender unlimited, age from 3 years to 70 years.
- Evidence for cell membrane CD19 and/or CD22 expression;
Key exclusion criteria (9 listed)
- Pregnancy and nursing females.
- Patients are allergic to cytokines.
- Uncontrolled active infection.
- Acute or chronic GVHD.
- Treated with T cell inhibitor.
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 |
|---|---|---|
| CD19 and CD22 targeted CAR-T cellsCAR-T cells were manufactured from peripheral blood mononuclear cells collected by leukapheresis and frozen for multiple uses. Before each CAR T-cell infusion (day 0), patients received lymphodepleting chemotherapy composing of Fludarabine (30 mg/m2/day) and Cyclophosphamide (300 mg/m2/day) on days -5 to -3. No bridging chemotherapy was given between enrollment and infusion. In sequential CAR-T clinical trials, CAR-T cells will be given.（anti-CD19 CAR-T first, then anti-CD22 CAR-T). | Biological | arm 1 |
Primary outcome
Adverse events that related to treatment
Time frame: 1 years
Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).
Overall remission rate (ORR)
Time frame: 3 months
The ORR of Sequential CD19 and CD22 CAR-T treatment will be recorded and assessed according to the revised 2014 Lugano Criteria.
5 secondary outcomes
complete response(CR)
Time frame: 24 months
partial response(PR)
Time frame: 24 months
stable disease(SD)
Time frame: 24 months
progressive disease(PD)
Time frame: 24 months
Duration of remission (DOR)
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
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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.
li xiangqun, doctor study chair
Kecellitics Biotech Company Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CD19 and CD22 targeted CAR-T cells in people with Lymphoma, B-Cell, run by Kecellitics Biotech Company Ltd 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 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: status not confirmed, as of the sponsor's last update on 14 Dec 2022. 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 combined 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact li xiangqun, doctor (086-15712867910, xiangqun_li@doingtimes.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events that related to treatment (time frame: 1 years). 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 14 Dec 2022.