CD19+ and CD 22+ B-ALLEarly Phase 1NCT05225831
Safety and Efficacy of CD19/CD22 Dual Targeted CAR-T Cell Therapy in R/R B-Cell Acute Lymphoblastic Leukemia
A Early Phase 1 study testing Autologous CD19/CD22 Chimeric Antigen Receptor T-cells and Cyclophosphamide,Fludarabine in people with CD19+ and CD 22+ B-ALL, run by Hebei Senlang Biotechnology Inc., Ltd. at 1 site in China.
Trial summary
This is an open, single-arm, prospective clinical study to evaluate the safety and efficacy of anti CD19 and CD22 CAR-T cell in the treatment of R/R B-ALL. Read more about this study
- Who is it for?
- Ages 2 to 70 years
- Conditions the study is for
- CD19+ and CD 22+ B-ALL
- What is being tested?
- Autologous CD19/CD22 Chimeric Antigen Receptor T-cells and Cyclophosphamide,Fludarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2021to Nov 2023
- Phase
- Early 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 2 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Sign the informed consent and be willing and able to comply with the visit, treatment regimen, laboratory examination and other requirements of the study as stipulated in the trial flow chart;
- A definite diagnosis of B-cell Lymphocyte Leukemia, which meets any of the following criteria: Relapsed : a) relapsed within 12 months after first remission;Refractory: a) no remission after six weeks of induction therapy or no remission after two courses of induction therapy; b) relapsedafter CR for 2 or more times; c) The first relapse after chemotherapy and no remission after at least one salvage treatment; c) relapsed after hematopoietic stem cell transplantation;
- ECOG Scores: 0~2
- CD19 positive and CD22 positive were detected by immunohistochemistry or flow cytometry;
- Estimated survival time>3 months;
- Peripheral blood mononuclear immune cells must be collected at least 2 weeks after the last radiotherapy or systemic treatment.
- For patients with only extramedullary recurrence of B-ALL, there must be at least one assessable lesion.
Who cannot join
- Serious cardiac insufficiency；
- Has a history of severe pulmonary function damaging;
- Presence of other malignant tumors.
- Presence of active fungal, bacterial, viral, or other infection requiring IV antibiotics for management.
- Presence of other severe autoimmune diseases or immunodeficiency disease;
- Patients with active hepatitis B or hepatitis C([HBVDNA+]or [HCVRNA+]);
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- Known positive serology for human immunodeficiency virus (HIV) or syphilis。
- Has a history of serious allergies on biological products (including antibiotics);
- Female patients who are under pregnancy and/or lactation, or planing on pregnancy for the next 12 months.
- Any other situations that the researchers believe will affect the results of the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hebei Yanda Ludaopei Hospital
Langfang, Hebei
Peihua LU, PhD&MD
About this study
Official title: Safety and Efficacy of CD19/CD22 Dual Targeted CAR-T Cell Therapy in Patients With R/R B-Cell Acute Lymphoblastic Leukemia
This is an open, single-arm, prospective clinical study to evaluate the safety and efficacy of anti CD19 and CD22 CAR-T cell in the treatment of R/R B-ALL.
Read the detailed description
CD19-directed CAR-T cell therapy has shown promising results in the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia. CD19 and CD22 are proteins usually expressed on the surface of the B leukemia cells. The dual-CARs enables the T-cells to recognize and kill the tumor cell through recognition of CD19 and CD22.
- Conditions
- CD19+ and CD 22+ B-ALL
- Being tested
- Autologous CD19/CD22 Chimeric Antigen Receptor T-cells, Cyclophosphamide,Fludarabine
- Keywords
- CD19, CD22, B-ALL, CAR-T
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous CD19/CD22 Chimeric Antigen Receptor T-cellsBiological
Also called SL19+22 CAR-T
A single infusion of CD19 and CD22 CAR-T cells.
Cyclophosphamide,FludarabineDrug
Given
| Study group | Role | What they receive |
|---|---|---|
| SL19+22 CAR-T | Experimental | Eligible patients will be treated with SL19+22 CAR-T. Receives: Biological: Autologous CD19/CD22 Chimeric Antigen Receptor T-cells; Drug: Cyclophosphamide,Fludarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Incidence of adverse events
To evaluate the possible adverse events that could occurred within the first month post SL19+22 infusion, including symptoms such as cytokine release syndrome and neurotoxicity.
Measured: up to 28 days
Efficacy: Remission Rate
Remission Rate includes complete remission(CR)、CR with incomplete blood count recovery(CRi)、No remission(NR)
Measured: Up to 3 months
Secondary outcomes (4)
Efficacy:duration of response (DOR)
Duration of response
Measured: 24 months post CAR-T cells infusion
Efficacy: progression-free survival (PFS)
progression-free survival (PFS) time
Measured: 24 months post CAR-T cells infusion
CAR-T proliferation
the copy number of CD19 and CD22 CAR- T cells in the genomes of peripheral blood mononuclear cell (PBMC) by quantitative Real-time PCR (qPCR).
Measured: 3 months post CAR-T cells infusion
Cytokine release
Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry
Measured: First month post CAR-T cells infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start15 Aug 2021
- Primary completionAug 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CD19+ and CD 22+ B-ALLStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Senlang Biotechnology Inc., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hebei Yanda Ludaopei Hospital
- Responsible party
- Sponsor
- Investigators
- Peihua Lu, PhD&MD, Principal investigator, Beijing Lu Daopei Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05225831
- Sponsor's protocol ID
- SL19+22 for B-ALL
- Status last verified
- Jan 2022
- First submitted
- 11 Jan 2022
- Last updated
- 7 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of CD19/CD22 Dual Targeted CAR-T Cell Therapy in Patients With R/R B-Cell Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT05225831
- Acronym / sponsor ID
- SL19+22 for B-ALL
- Conditions
- CD19+ and CD 22+ B-ALL
- Keywords
- CD19, CD22, B-ALL, CAR-T
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hebei Senlang Biotechnology Inc., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Hebei Yanda Ludaopei Hospital
- Study start
- 15 Aug 2021 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 7 Feb 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 an open, single-arm, prospective clinical study to evaluate the safety and efficacy of anti CD19 and CD22 CAR-T cell in the treatment of R/R B-ALL.
Detailed description
CD19-directed CAR-T cell therapy has shown promising results in the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia. CD19 and CD22 are proteins usually expressed on the surface of the B leukemia cells. The dual-CARs enables the T-cells to recognize and kill the tumor cell through recognition of CD19 and CD22.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SL19+22 CAR-T | Experimental | Biological: Autologous CD19/CD22 Chimeric Antigen Receptor T-cells, Drug: Cyclophosphamide,FludarabineEligible patients will be treated with SL19+22 CAR-T. |
Who may qualify
- Ages
- 2 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Sign the informed consent and be willing and able to comply with the visit, treatment regimen, laboratory examination and other requirements of the study as stipulated in the trial flow chart;
- A definite diagnosis of B-cell Lymphocyte Leukemia, which meets any of the following criteria: Relapsed : a) relapsed within 12 months after first remission;Refractory: a) no remission after six weeks of induction therapy or no remission after two courses of induction therapy; b) relapsedafter CR for 2 or more times; c) The first relapse after chemotherapy and no remission after at least one salvage treatment; c) relapsed after hematopoietic stem cell transplantation;
- ECOG Scores: 0~2
- CD19 positive and CD22 positive were detected by immunohistochemistry or flow cytometry;
- Estimated survival time>3 months;
Key exclusion criteria (10 listed)
- Serious cardiac insufficiency；
- Has a history of severe pulmonary function damaging;
- Presence of other malignant tumors.
- Presence of active fungal, bacterial, viral, or other infection requiring IV antibiotics for management.
- Presence of other severe autoimmune diseases or immunodeficiency disease;
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 |
|---|---|---|
| Autologous CD19/CD22 Chimeric Antigen Receptor T-cellsAlso: SL19+22 CAR-TA single infusion of CD19 and CD22 CAR-T cells. | Biological | SL19+22 CAR-T |
| Cyclophosphamide,FludarabineGiven | Drug | SL19+22 CAR-T |
Primary outcome
Safety: Incidence of adverse events
Time frame: up to 28 days
To evaluate the possible adverse events that could occurred within the first month post SL19+22 infusion, including symptoms such as cytokine release syndrome and neurotoxicity.
Efficacy: Remission Rate
Time frame: Up to 3 months
Remission Rate includes complete remission(CR)、CR with incomplete blood count recovery(CRi)、No remission(NR)
4 secondary outcomes
Efficacy:duration of response (DOR)
Time frame: 24 months post CAR-T cells infusion
Efficacy: progression-free survival (PFS)
Time frame: 24 months post CAR-T cells infusion
CAR-T proliferation
Time frame: 3 months post CAR-T cells infusion
Cytokine release
Time frame: First month post CAR-T cells infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
Related trials for CD19+ and CD 22+ B-ALL
Enrolling by invitationPhase 1/2
This is a Phase I/II Interventional, Open-label Treatment Study Designed to Evaluate the Safety and Efficacy of Anti CD 19/22 CAR- T Cells Immunotherapy for Adults With Relapsed or Refractory Acute Lymphoblastic Leukemia/Lymphoma.
Acute Lymphobkastic Leukemia, B Cell Lymphoma
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.
Peihua Lu, PhD&MD principal investigator
Beijing Lu Daopei Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Autologous CD19/CD22 Chimeric Antigen Receptor T-cells and Cyclophosphamide,Fludarabine in people with CD19+ and CD 22+ B-ALL, run by Hebei Senlang Biotechnology Inc., 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 7 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 7 Feb 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Peihua Lu, PhD&MD (008618611636172, peihua_lu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Incidence of adverse events (time frame: up to 28 days). 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 7 Feb 2022.