B Cell LymphomaPhase 1/2NCT04782193
a Clinical Research of CD19 and CD22 Targeted Prime CAR-T Cell in Relapsed/Refractory B Cell Lymphoma
A Phase 1/2 study testing CD19 and CD22 targeted prime CAR- T cells in people with B Cell Lymphoma, run by Chongqing Precision Biotech Co., Ltd at 1 site in China.
Trial summary
This is a single arm study to evaluate the efficacy and safety of CD19 and CD22 targeted prime CAR-T cells therapy for patients with relapsed/refractory B Cell Lymphoma Read more about this study
- Who is it for?
- Ages 2 to 75 years
- Conditions the study is for
- B Cell Lymphoma
- What is being tested?
- CD19 and CD22 targeted prime 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
- 1 siteChina
- Study dates
- 23 May 2021to 1 Jul 2024
- 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 2 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Signed written informed consent
- Diagnose as Relapsed and Refractory B -ALL, and meet one of the following conditions:
- Failed to standard chemotherapy regimens;
- Relapse after complete remission, high-risk and / or refractory patients ;
- Relapse after hematopoietic stem cell transplantation;
- Evidence for cell membrane CD19 or CD22 expression
Show all 16Show fewer
- All genders ages: 2 to 75 years
- The expect time of survive is above 3 months;
- KPS>60
- No serious mental disorders ;
- Left ventricular ejection fraction ≥50%
- Sufficient hepatic function defined by ALT/AST≤3 x ULN and bilirubin≤2 x ULN;
- Sufficient renal function defined by creatinine clearance≤2 x ULN;
- Sufficient pulmonary function defined by indoor oxygen saturation≥92%;
- With single or venous blood collection standards, and no other cell collection contraindications;
- Ability and willingness to adhere to the study visit schedule and all protocol requirements.
Who cannot join
- Previous history of other malignancy;
- Presence of uncontrolled active infection;
- Evidence of disorder that need the treatment by glucocorticoids;
- Active or chronic GVHD
- The patients treatment by inhibitor of T cell
- Pregnant or breasting-feeding women;
- Any situation that investigators regard not suitable for attending in this study (e.g. HIV , HCVinfection or intravenous drug addiction) or may affect the data analysis.
Trial locations and contacts
1 site in 1 country.
Sanbin Wang, MD contact
China1 site, 1 recruiting
- Recruiting
920th Hospital of Joint Logistics Support Force
Kunming, Yunnnan
Sanbin Wang, MD, Sanbin1011@163.com
Sanbin Wang, MD
About this study
Official title: Study Evaluating Safety and Efficacy of CD19 and CD22 Targeted Prime CAR-T Cell in Patients With Relapsed/Refractory B Cell Lymphoma
This is a single arm study to evaluate the efficacy and safety of CD19 and CD22 targeted prime CAR-T cells therapy for patients with relapsed/refractory B Cell Lymphoma
Read the detailed description
Although the anti-CD19 CAR-T cell therapies have gained significant results in patients with relapsed and refractory B-cell hematologic malignancies.
There are patients who resisted anti-CD19 CAR-T cells or with CD19 negative relapse. To make further improvement, the investigators launch such a clinical trial using CD19 and CD22 targeted prime CAR-T cells for patients with relapsed and refractory B Cell Lymphomato evaluate the efficacy and safety of CD19 and CD22 targeted prime CAR-T cell therapy.
- Conditions
- B Cell Lymphoma
- Being tested
- CD19 and CD22 targeted prime CAR- T cells
- Keywords
- CD19, CD22, CAR-T
- 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.
CD19 and CD22 targeted prime CAR- T cellsBiological
A single infusion of CD19 and CD22 prime CAR-T cells will be administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| prime CAR- T cells | Experimental | Patients will be be treated with CD19 and CD22 prime CAR- T cells Receives: Biological: CD19 and CD22 targeted prime 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: 2 years
The response rate of CD19 and CD22 prime CAR-T treatment in patients with relapse/refractory B Cell Lymphoma
The response rate of CD19 and CD22 prime CAR-T treatment will be recorded and assessed according to the National Comprehensive Cancer Network Guideline
Measured: 6 months
Secondary outcomes (12)
Rate of prime CAR-T cells in bone marrow
Determine the rate of prime CAR-T cells in bone marrow by means of flow cytometry
Measured: 2 years
Rate of prime CAR-T cells in peripheral blood
Determine the rate of prime CAR-T cells in peripheral blood by means of flow cytometry
Measured: 2 years
Quantity of prime CAR copies in bone marrow
Determine the quantity of prime CAR copies in bone marrow by qPCR
Measured: 2 years
Quantity of prime CAR copies in peripheral blood
Determine the quantity of prime CAR copies in peripheral blood by qPCR
Measured: 2 years
Rate of CD19 and CD22 positive cells in Bone marrow
Determine the rate of CD19 and CD22 positive cells in bone marrow by flow cytometry
Measured: 1 years
Levels of IL-6 in Serum
Serological determination of IL-6
Measured: 3 months
Levels of IL-10 in Serum
Serological determination of IL-10
Measured: 3 months
Levels of TNF-α in Serum
Serological determination of TNF-α
Measured: 3 months
Levels of CRP in Serum
Serological determination of CRP
Measured: 3 months
Duration of Response (DOR) of CD19 and CD22 prime CAR-T treatment in patients with refractory/relapsed B Cell Lymphoma
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 (censored)
Measured: 2 years
Progress-free survival(PFS) of CD19 and CD22 targeted prime CAR-T treatment in patients with refractory/relapsed B Cell Lymphoma
PFS will be assessed from the first prime CAR-T cell infusion to death from any cause or the first assessment of progression (censored)
Measured: 2 years
Overall survival(OS) of CD19 and CD22 prime CAR-T treatment in patients with refractory/relapsed B Cell Lymphoma
OS will be assessed from the first primeCAR-T cell infusion to death from any cause (censored)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start23 May 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Chongqing Precision Biotech Co., LtdThe sponsor's other registered studies.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing Precision Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sanbin Wang, MD, Principal investigator, 920th Hospital of Joint Logistics Support Force of People's Liberation Army of ChinaCheng Qian, PhD, Principal investigator, Chongqing University Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04782193
- Sponsor's protocol ID
- PBC026
- Status last verified
- Apr 2023
- First submitted
- 26 Feb 2021
- Last updated
- 18 Apr 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 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Evaluating Safety and Efficacy of CD19 and CD22 Targeted Prime CAR-T Cell in Patients With Relapsed/Refractory B Cell Lymphoma
- ClinicalTrials.gov ID
- NCT04782193
- Acronym / sponsor ID
- PBC026
- Conditions
- B Cell Lymphoma
- Keywords
- CD19, CD22, CAR-T
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chongqing Precision Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 23 May 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 4 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 is a single arm study to evaluate the efficacy and safety of CD19 and CD22 targeted prime CAR-T cells therapy for patients with relapsed/refractory B Cell Lymphoma
Detailed description
Although the anti-CD19 CAR-T cell therapies have gained significant results in patients with relapsed and refractory B-cell hematologic malignancies.
There are patients who resisted anti-CD19 CAR-T cells or with CD19 negative relapse. To make further improvement, the investigators launch such a clinical trial using CD19 and CD22 targeted prime CAR-T cells for patients with relapsed and refractory B Cell Lymphomato evaluate the efficacy and safety of CD19 and CD22 targeted prime 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 |
|---|---|---|
| prime CAR- T cells | Experimental | Biological: CD19 and CD22 targeted prime CAR- T cellsPatients will be be treated with CD19 and CD22 prime CAR- T cells |
Who may qualify
- Ages
- 2 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- Signed written informed consent
- Diagnose as Relapsed and Refractory B -ALL, and meet one of the following conditions:
- Evidence for cell membrane CD19 or CD22 expression
- All genders ages: 2 to 75 years
- The expect time of survive is above 3 months;
Key exclusion criteria (7 listed)
- Previous history of other malignancy;
- Presence of uncontrolled active infection;
- Evidence of disorder that need the treatment by glucocorticoids;
- Active or chronic GVHD
- The patients treatment by inhibitor of T cell
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 prime CAR- T cellsA single infusion of CD19 and CD22 prime CAR-T cells will be administered intravenously | Biological | prime CAR- T cells |
Primary outcome
Adverse events that related to treatment
Time frame: 2 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)
The response rate of CD19 and CD22 prime CAR-T treatment in patients with relapse/refractory B Cell Lymphoma
Time frame: 6 months
The response rate of CD19 and CD22 prime CAR-T treatment will be recorded and assessed according to the National Comprehensive Cancer Network Guideline
12 secondary outcomes
Rate of prime CAR-T cells in bone marrow
Time frame: 2 years
Rate of prime CAR-T cells in peripheral blood
Time frame: 2 years
Quantity of prime CAR copies in bone marrow
Time frame: 2 years
Quantity of prime CAR copies in peripheral blood
Time frame: 2 years
Rate of CD19 and CD22 positive cells in Bone marrow
Time frame: 1 years
Levels of IL-6 in Serum
Time frame: 3 months
Levels of IL-10 in Serum
Time frame: 3 months
Levels of TNF-α in Serum
Time frame: 3 months
Levels of CRP in Serum
Time frame: 3 months
Duration of Response (DOR) of CD19 and CD22 prime CAR-T treatment in patients with refractory/relapsed B Cell Lymphoma
Time frame: 2 years
Progress-free survival(PFS) of CD19 and CD22 targeted prime CAR-T treatment in patients with refractory/relapsed B Cell Lymphoma
Time frame: 2 years
Overall survival(OS) of CD19 and CD22 prime CAR-T treatment in patients with refractory/relapsed B Cell Lymphoma
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 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. This study is not recruiting at the moment.
Sanbin Wang, MD contact
Sanbin Wang, MD principal investigator
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Cheng Qian, PhD principal investigator
Chongqing University Cancer Hospital
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 prime CAR- T cells in people with B Cell Lymphoma, run by Chongqing Precision Biotech Co., 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 16 inclusion and 7 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 18 Apr 2023. 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 Zhi Yang, PhD (86-13206140093, yangzhi@precision-biotech.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: 2 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 18 Apr 2023.