Acute Lymphoblastic LeukemiaPhase 1NCT04888468
Phase I Study of pCAR-19B in the Treatment of CD19-positive Relapsed/Refractory B-ALL in Children and Adolescents
A Phase 1 study testing pCAR-19B cells in people with Acute Lymphoblastic Leukemia and Relapsed Pediatric ALL, run by Chongqing Precision Biotech Co., Ltd at 1 site in China.
Trial summary
This is a phase I clinical study to evaluate the safety and tolerability of pCAR-19B in patients with relapsed or refractory B-ALL, and to obtain the maximum tolerated dose of pCAR-19B and phase II Recommended dose. Read more about this study
- Who is it for?
- Ages 3 to 21 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Relapsed Pediatric ALL, Refractory Acute Lymphoblastic Leukemia
- What is being tested?
- pCAR-19B cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 5 Nov 2019to 1 Sep 2021
- 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 3 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosed with B-ALL，and meet one of the following conditions:
- First-line or multiple-line salvage chemotherapy did not achieve complete remission；
- Early relapse after complete remission (<12 months), or late relapse after complete remission (≥12 months) and complete remission has not been achieved after 1 course of treatment；
- Relapse after autologous or allogeneic hematopoietic stem cell transplantation;
- Ph+ALL patients should also receive at least two TKI treatments；
- For allogeneic hematopoietic stem cell transplant subjects, the following conditions must be met：
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- Allo-HSCT takes ≥6 months before pCAR-19B infusion；
- No GVHD of grade 2 or above occurred within 2 weeks before PBMC collection;
- Express CD19;
- 3~21 years old, no gender limit;
- The expected survival time is more than 12 weeks;
- KPS>60;
- No serious mental disorders;
- The function of important organs is basically normal:
- Heart function: echocardiography indicates that the cardiac ejection fraction is ≥50%, and the electrocardiogram has no obvious abnormalities;
- Renal function: serum creatinine≤2.0×ULN;
- Liver function: ALT and AST ≤5×ULN;
- Total bilirubin and alkaline phosphatase≤3×ULN ;
- Blood oxygen saturation>92%.
- Have standards for apheresis or venous blood collection, and no other cell collection contraindications;
- The patient himself or his guardian agrees to participate in the clinical trial and signs the ICF, indicating that he understands the purpose and procedures of the clinical trial and is willing to participate in the research.
Who cannot join
- With central nervous system disease at the time of screening;
- Have received CAR-T therapy or other genetically modified cell therapy;
- Participated in other clinical studies within 1 month before screening;
- Have received the following anti-tumor treatments before screening: received chemotherapy, targeted therapy or other experimental drug treatments within 14 days or at least 5 half-lives (whichever is shorter);
- Have received a live attenuated vaccine within 4 weeks before screening;
- Cerebrovascular accident or seizure occurred within 6 months before signing the ICF;
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- Suffered from any of the following heart diseases:
- NYHA stage III or IV congestive heart failure;
- Myocardial infarction or CABG occurred ≤6 months before enrollment;
- Clinically significant ventricular arrhythmia, or history of unexplained syncope (except for cases caused by vasovagal or dehydration);
- History of severe non-ischemic cardiomyopathy.
- Uncontrollable infection in the 2 weeks before screening；
- Active autoimmune diseases；
- Patients with malignant tumors other than acute lymphoblastic leukemia within 5 years before screening, except for fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical resection, and duct in situ after radical resection cancer；
- HBsAg or HBcAb positive and HBV DNA is greater than the normal range; HCV antibody is positive and HCV RNA greater than the normal range; HIV antibody positive; syphilis positive; CMV DNA positive;
- Women who are pregnant or breastfeeding, and male or female subjects who plan to have children within 1 year after receiving pCAR-19B cell reinfusion;
- Other situations considered by the researcher to be unsuitable to participate in the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei
About this study
Official title: A Phase I Clinical Study of Anti-CD19 CAR-T Therapy (pCAR-19B) in the Treatment of CD19-positive Relapsed/Refractory B-ALL
This is a phase I clinical study to evaluate the safety and tolerability of pCAR-19B in patients with relapsed or refractory B-ALL, and to obtain the maximum tolerated dose of pCAR-19B and phase II Recommended dose.
Read the detailed description
This is a single-center, single-arm, open-label study. The study plans to set up 3 dose groups, adopting a dose-escalating 3+3 design, and plan to recruit about 9-18 subjects with relapsed or refractory B-ALL.pCAR-19B will be infused to the subject by intravenous infusion.
- Conditions
- Acute Lymphoblastic Leukemia, Relapsed Pediatric ALL, Refractory Acute Lymphoblastic Leukemia
- Being tested
- pCAR-19B cells
- Keywords
- CAR-T, CD19, B-ALL
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pCAR-19B cellsBiological
Drug: pCAR-19B cells； Administration method: intravenous infusion； Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion.
| Study group | Role | What they receive |
|---|---|---|
| pCAR-19B cells | Experimental | Infusion of pCAR-19B cells by dose-escalating Receives: Biological: pCAR-19B cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse events after pCAR-19B infusion [Safety and Tolerability]
Therapy-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
Measured: 28 days
Obtain the maximum tolerated dose of pCAR-19B cells[Safety and Tolerability]
Dose-limiting toxicity after cell infusion
Measured: 28 days
Secondary outcomes (6)
Objective response rate after pCAR-19B infusion [Effectiveness]
Objective response rate includes CR, CRi
Measured: 3 months
AUCS of pCAR-19B cells [Cell dynamics]
AUCS is defined as the area under the curve in 28 days and 90 days
Measured: 3 months
CMAX of pCAR-19B cells [Cell dynamics]
CMAX is defined as the highest concentration of pCAR-19B cells expanded in peripheral blood
Measured: 3 months
TMAX of pCAR-19B cells [Cell dynamics]
TMAX is defined as the time to reach the highest concentration
Measured: 3 months
Pharmacodynamics of pCAR-19B cells[Cell dynamics]
Cytokines such as hs-CRP, IL-6 levels
Measured: 3 months
Immunogenicity of pCAR-19B cells
Anti-CAR antibody
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start5 Nov 2019
- Primary completion29 Jun 2021
- Study completion1 Sep 2021
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.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chongqing Precision Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianfeng Zhou, M.D. Ph.D, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04888468
- Sponsor's protocol ID
- PB01
- Status last verified
- May 2021
- First submitted
- 12 May 2021
- Last updated
- 18 Mar 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 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study of Anti-CD19 CAR-T Therapy (pCAR-19B) in the Treatment of CD19-positive Relapsed/Refractory B-ALL
- ClinicalTrials.gov ID
- NCT04888468
- Acronym / sponsor ID
- PB01
- Conditions
- Acute Lymphoblastic Leukemia, Relapsed Pediatric ALL, Refractory Acute Lymphoblastic Leukemia
- Keywords
- CAR-T, CD19, B-ALL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Chongqing Precision Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 5 Nov 2019 (actual)
- Primary completion
- 29 Jun 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 17 May 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 phase I clinical study to evaluate the safety and tolerability of pCAR-19B in patients with relapsed or refractory B-ALL, and to obtain the maximum tolerated dose of pCAR-19B and phase II Recommended dose.
Detailed description
This is a single-center, single-arm, open-label study. The study plans to set up 3 dose groups, adopting a dose-escalating 3+3 design, and plan to recruit about 9-18 subjects with relapsed or refractory B-ALL.pCAR-19B will be infused to the subject by intravenous infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pCAR-19B cells | Experimental | Biological: pCAR-19B cellsInfusion of pCAR-19B cells by dose-escalating |
Who may qualify
- Ages
- 3 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (21 listed)
- Diagnosed with B-ALL，and meet one of the following conditions:
- Ph+ALL patients should also receive at least two TKI treatments；
- For allogeneic hematopoietic stem cell transplant subjects, the following conditions must be met：
- Express CD19;
- 3~21 years old, no gender limit;
Key exclusion criteria (17 listed)
- With central nervous system disease at the time of screening;
- Have received CAR-T therapy or other genetically modified cell therapy;
- Participated in other clinical studies within 1 month before screening;
- Have received the following anti-tumor treatments before screening: received chemotherapy, targeted therapy or other experimental drug treatments within 14 days or at least 5 half-lives (whichever is shorter);
- Have received a live attenuated vaccine within 4 weeks before screening;
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 |
|---|---|---|
| pCAR-19B cellsDrug: pCAR-19B cells； Administration method: intravenous infusion； Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion. | Biological | pCAR-19B cells |
Primary outcome
Incidence of Adverse events after pCAR-19B infusion [Safety and Tolerability]
Time frame: 28 days
Therapy-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
Obtain the maximum tolerated dose of pCAR-19B cells[Safety and Tolerability]
Time frame: 28 days
Dose-limiting toxicity after cell infusion
6 secondary outcomes
Objective response rate after pCAR-19B infusion [Effectiveness]
Time frame: 3 months
AUCS of pCAR-19B cells [Cell dynamics]
Time frame: 3 months
CMAX of pCAR-19B cells [Cell dynamics]
Time frame: 3 months
TMAX of pCAR-19B cells [Cell dynamics]
Time frame: 3 months
Pharmacodynamics of pCAR-19B cells[Cell dynamics]
Time frame: 3 months
Immunogenicity of pCAR-19B cells
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 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.
Jianfeng Zhou, M.D. Ph.D principal investigator
Tongji 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 study testing pCAR-19B cells in people with Acute Lymphoblastic Leukemia and Relapsed Pediatric ALL, 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 21 inclusion and 17 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: finished, as of the sponsor's last update on 18 Mar 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?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse events after pCAR-19B infusion [Safety and Tolerability] (time frame: 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 18 Mar 2022.