CD19+ Relapse/Refractory B-ALLPhase 1NCT05270772
CAR-T-19 Cells for Patients With CD19+ Relapse/Refractory B-ALL
A Phase 1 study testing CAR-T-19 Cells in people with CD19+ Relapse/Refractory B-ALL, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
This is a single-arm, open-label phase I study to determine the safety, tolerability, and recommended dose (RD) of CAR-T-19 cells for patients with CD19+ relapse/refractory B-ALL under the age of 25. Read more about this study
- Who is it for?
- Ages Up to 25 years
- Conditions the study is for
- CD19+ Relapse/Refractory B-ALL
- What is being tested?
- CAR-T-19 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
- 25 Feb 2021to 16 Sep 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 Up to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with relapse/refractory B-ALL.
- Tumor cells from bone marrow or peripheral blood are measured CD19+ with 3 months before enrollment.
- Karnofsky Score ≥ 70 or Lansky Score ≥ 50.
- Patients who have a life expectancy of at least 12 weeks.
- Understand and voluntarily sign informed consent and are willing to comply with laboratory tests and other research procedures.
Who cannot join
- Patients with extramedullary relapse (EMR).
- Patients with genetic diseases, Burkitt lymphoma and leukemia or other malignancies.
- Patients positive for any of the following: HbsAg, HBV-DNA, HCV-Ab, HCV-RNA, HIV-Ab, TP-Ab, EBV-DNA or CMV-DNA.
- Patients with other uncontrolled infection.
- Patients who received anti-CD19 / anti-CD3 therapy, or any other anti-CD19 therapy.
- Patients with active Grade II-IV GVHD within 3 months prior to screening.
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- Tumor cells are detected in cerebrospinal fluid.
- Patients who received HSCT within 3 months prior to screening.
- Anticipated other clinical trials within 4 weeks before this trial
- Pregnant or lactating women.
- Any condition that would, in the investigator's judgment, make it unsuitable for the donors to be enrolled.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Daihong Liu, +8613681171597, daihongrm@163.com
Daihong Liu
About this study
Official title: A Single-arm, Open-label Phase I Study of CAR-T-19 (Anti CD19 scFv Chimeric Antigen Receptor T) Cells for Patients With CD19-positive Recurrent or Refractory B-cell Acute Lymphoblastic Leukemia Under The Age of 25
This is a single-arm, open-label phase I study to determine the safety, tolerability, and recommended dose (RD) of CAR-T-19 cells for patients with CD19+ relapse/refractory B-ALL under the age of 25.
Read the detailed description
B-cell acute lymphoblastic leukemia (B-ALL) accounting for 85% of all ALL cases, is a common hematological malignancy in children and adults. CD19 is a widely expressed antigen in both normal B cells and B cells-derived leukemia and lymphomas. This is a single-arm, open-label phase I study of CAR-T-19 (anti CD19 scFv chimeric antigen receptor T) cells for patients with CD19-positive relapse/refractory B-ALL under the age of 25.
Primary endpoint is to determine the safety, tolerability, and recommended dose (RD) of CAR-T-19. Secondary endpoints measure ORR, OS and others.
- Conditions
- CD19+ Relapse/Refractory B-ALL
- Being tested
- CAR-T-19 Cells
- Keywords
- B-ALL, CAR-T
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR-T-19 CellsBiological
T cells were isolated from the PBMC of patients, transduced with lentivirus, expanded in vitro, and infused into patients. The escalated doses include 0.5×10^6/kg,1.5×10^6/kg, 5.0×10^6/kg CAR+ cells.
| Study group | Role | What they receive |
|---|---|---|
| CAR-T-19 Cells | Experimental | The patients with CD19+ relapse or refractory B-ALL will receive a single infusion of autologous CAR-T-19 cells, with the escalated dose ranging from 0.5×10^6/kg to 5.0×10^6/kg CAR+ cells. Receives: Biological: CAR-T-19 Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity (DLT)
DLT within 28 days (±3 days) after CAR-T-19 infusion.
Measured: up to 2 years
Maximum tolerated dose (MTD)
The maximum dose of DLT occurred in ≤1/6 of the subjects within 28 days (±3 days) after CAR-T-19 infusion.
Measured: up to 2 years
Adverse events
Percentage of subjects with adverse events.
Measured: up to 2 years
Secondary outcomes (5)
Overall recovery rate (ORR)
Percentage of subjects who achieved complete response (CR) and incomplete hematologic recovery (CRi) for the first time at Day 28 and Day 90 after CAR-T-19 infusion.
Measured: up to 2 years
MRD-Negative Rate
Percentage of subjects with MRD-negative CR and incomplete blood and MRD-negative CRi for the first time at Day 28 and Day 90 after CAR-T-19 infusion.
Measured: up to 2 years
Duration of Response (DOR)
The time from achieving CR and CRi for the first time to recurrence or death from any cause
Measured: up to 2 years
Progression-free Survival (PFS)
The time from CAR-T-19 infusion to recurrence, progression or death from any cause, whichever occurs first.
Measured: up to 2 years
Overall survival (OS)
The time from CAR-T-19 infusion to death from any cause.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start25 Feb 2021
- Primary completion15 Jul 2022 (estimated)
- Study completion16 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CD19+ Relapse/Refractory B-ALLStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daihong Liu, Chinese PLA General Hospital
- Investigators
- Daihong Liu, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05270772
- Sponsor's protocol ID
- CT19-ALL-02
- Status last verified
- Jan 2022
- First submitted
- 26 Feb 2022
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open-label Phase I Study of CAR-T-19 (Anti CD19 scFv Chimeric Antigen Receptor T) Cells for Patients With CD19-positive Recurrent or Refractory B-cell Acute Lymphoblastic Leukemia Under The Age of 25
- ClinicalTrials.gov ID
- NCT05270772
- Acronym / sponsor ID
- CT19-ALL-02
- Conditions
- CD19+ Relapse/Refractory B-ALL
- Keywords
- B-ALL, CAR-T
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 25 Feb 2021 (actual)
- Primary completion
- 15 Jul 2022 (estimated)
- Study completion
- 16 Sep 2024 (estimated)
- First posted
- 8 Mar 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, open-label phase I study to determine the safety, tolerability, and recommended dose (RD) of CAR-T-19 cells for patients with CD19+ relapse/refractory B-ALL under the age of 25.
Detailed description
B-cell acute lymphoblastic leukemia (B-ALL) accounting for 85% of all ALL cases, is a common hematological malignancy in children and adults. CD19 is a widely expressed antigen in both normal B cells and B cells-derived leukemia and lymphomas. This is a single-arm, open-label phase I study of CAR-T-19 (anti CD19 scFv chimeric antigen receptor T) cells for patients with CD19-positive relapse/refractory B-ALL under the age of 25.
Primary endpoint is to determine the safety, tolerability, and recommended dose (RD) of CAR-T-19. Secondary endpoints measure ORR, OS and others.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAR-T-19 Cells | Experimental | Biological: CAR-T-19 CellsThe patients with CD19+ relapse or refractory B-ALL will receive a single infusion of autologous CAR-T-19 cells, with the escalated dose ranging from 0.5×10^6/kg to 5.0×10^6/kg CAR+ cells. |
Who may qualify
- Ages
- Up to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patients with relapse/refractory B-ALL.
- Tumor cells from bone marrow or peripheral blood are measured CD19+ with 3 months before enrollment.
- Karnofsky Score ≥ 70 or Lansky Score ≥ 50.
- Patients who have a life expectancy of at least 12 weeks.
- Understand and voluntarily sign informed consent and are willing to comply with laboratory tests and other research procedures.
Key exclusion criteria (11 listed)
- Patients with extramedullary relapse (EMR).
- Patients with genetic diseases, Burkitt lymphoma and leukemia or other malignancies.
- Patients positive for any of the following: HbsAg, HBV-DNA, HCV-Ab, HCV-RNA, HIV-Ab, TP-Ab, EBV-DNA or CMV-DNA.
- Patients with other uncontrolled infection.
- Patients who received anti-CD19 / anti-CD3 therapy, or any other anti-CD19 therapy.
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 |
|---|---|---|
| CAR-T-19 CellsT cells were isolated from the PBMC of patients, transduced with lentivirus, expanded in vitro, and infused into patients. The escalated doses include 0.5×10^6/kg,1.5×10^6/kg, 5.0×10^6/kg CAR+ cells. | Biological | CAR-T-19 Cells |
Primary outcome
Dose limiting toxicity (DLT)
Time frame: up to 2 years
DLT within 28 days (±3 days) after CAR-T-19 infusion.
Maximum tolerated dose (MTD)
Time frame: up to 2 years
The maximum dose of DLT occurred in ≤1/6 of the subjects within 28 days (±3 days) after CAR-T-19 infusion.
Adverse events
Time frame: up to 2 years
Percentage of subjects with adverse events.
5 secondary outcomes
Overall recovery rate (ORR)
Time frame: up to 2 years
MRD-Negative Rate
Time frame: up to 2 years
Duration of Response (DOR)
Time frame: up to 2 years
Progression-free Survival (PFS)
Time frame: up to 2 years
Overall survival (OS)
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 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.
Daihong Liu principal investigator
Chinese PLA General 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 CAR-T-19 Cells in people with CD19+ Relapse/Refractory B-ALL, run by Chinese PLA General Hospital 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 5 inclusion and 11 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 8 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daihong Liu (+8613681171597, daihongrm@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 (DLT) (time frame: up to 2 years). The study lists 3 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 8 Mar 2022.