B-cell Acute Lymphoblastic LeukemiaPhase 1NCT03574168
CD19-CAR-T Cells in Patients With R/R B-ALL
A Phase 1 study testing CD19-CAR-T Cells in people with B-cell Acute Lymphoblastic Leukemia, run by Bioceltech Therapeutics, Ltd. at 1 site in China.
Trial summary
This is a single center, single arm, open-lable phase 1 study to determine the safety and efficacy of autologous or donor-derived allogeneic T cells expressing CD19 chimeric antigen receptors (referred to as "CD19-CAR-T cells") in patients with relapsed or refractory acute B-cell lymphoblastic leukemia (R/R B-ALL). Read more about this study
- Who is it for?
- Ages 3 to 70 years
- Conditions the study is for
- B-cell Acute Lymphoblastic Leukemia
- What is being tested?
- CD19-CAR-T Cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2018to 31 Dec 2019
- 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 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Obtain Informed Consent Form (ICF) voluntarily signed by the patient;
- Age 3-70 years old;
- Primary resistant or relapsed B-cell line acute lymphoblastic leukemia;
- B cells are positive for CD19 expression;
- Peripheral blood tumor cell load <50%; 6. KPS score >50 points;
- 7. Normal liver and kidney function; 8. Normal heart function; 9. Good follow-up compliance; 10. Women of childbearing age (15-49 years old) must have a pregnancy test within 7 days before treatment and have a negative result; Men and women with fertility should agree to use effective contraception to ensure that during the study period and following 3 months after treatment the women will not get pregnant.
Who cannot join
- Patients with non-B cell acute leukemia;
- Organ failure: Heart: Grade III and IV Liver: Class C with Child-Turcotte liver function classification Kidney: Renal failure and uremia Lung: severe respiratory failure Brain: Disabilities
- Active infection;
- Human immunodeficiency virus (HIV) positive;
- Acute and chronic graft-versus-host disease (GVHD)> Level 1；
- Pregnant or lactating women;
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- Patients do not agree to use effective contraception during the treatment period and following 3 months;
- Patients who participated in other clinical studies at the same time;
- The researcher believes that there are other factors that are not suitable for inclusion in or influence the subject's participation in or completion of the study;
- Long-term use greater doses of hormones than physiological doses.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hebei Yanda Ludaopei Hospital
Langfang, Hebei, 065000
Peihua Lu, MD, PhD, 18611636172, peihua_lu@126.com
About this study
Official title: Phase I Study of the Safety and Efficacy of CD19-CAR-T Cells in Patients With Relapsed or Refractory Acute B-cell Lymphoblastic Leukemia (R/R B-ALL)
This is a single center, single arm, open-lable phase 1 study to determine the safety and efficacy of autologous or donor-derived allogeneic T cells expressing CD19 chimeric antigen receptors (referred to as "CD19-CAR-T cells") in patients with relapsed or refractory acute B-cell lymphoblastic leukemia (R/R B-ALL).
Read the detailed description
Primary objective:
To investigate the safety and efficacy of autologous or HLA-haploidentical Allo-CD19-CAR-T cells in the treatment of patients with relapsed or refractory acute B-cell lymphoblastic leukemia.
Secondary objective:
To Assess the patient's quality of life after receiving the treatment.
- Conditions
- B-cell Acute Lymphoblastic Leukemia
- Being tested
- CD19-CAR-T Cells
- Medical subject headings
- Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD19-CAR-T CellsBiological
T cells purified from the PBMC of subjects or subjects' relatives which depends on their conditions, transduced with 4-1BB/CD3-ζ lentiviral vector, expanded in vitro for future administration.
| Study group | Role | What they receive |
|---|---|---|
| CD19-CAR-T Cells | Experimental | Subjects will receive CD19-CAR-T Cells on Day 0 : 100% of total dose. Receives: Biological: CD19-CAR-T Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate, ORR
The percentage of participants who achieved complete remission (CR) over all participants (CRR).
The percentage of participants who achieved partial remission (PR) over all participants (PRR).
Measured: Up to Day90 after the CD19-CAR-T cell infusion
Secondary outcomes (2)
The amount of CAR-T cells remaining in vivo
Measure and analyze monthly
Measured: 2 years after cell infusion.
The lifetime of CAR-T cells remaining in vivo
Measure and analyze monthly
Measured: 2 years after cell infusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2018
- Study start20 Jul 2018 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell Acute Lymphoblastic LeukemiaStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bioceltech Therapeutics, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peihua Lu, MD, PhD, Principal investigator, Hebei Yanda Ludaopei Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03574168
- Sponsor's protocol ID
- BT-ALL-001-v2
- Other IDs
- ChiCTR1800016541
- Status last verified
- Jun 2018
- First submitted
- 11 Jun 2018
- Last updated
- 29 Jun 2018
- Results posted
- 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 29 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of the Safety and Efficacy of CD19-CAR-T Cells in Patients With Relapsed or Refractory Acute B-cell Lymphoblastic Leukemia (R/R B-ALL)
- ClinicalTrials.gov ID
- NCT03574168
- Acronym / sponsor ID
- BT-ALL-001-v2
- Conditions
- B-cell Acute Lymphoblastic Leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Bioceltech Therapeutics, Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Jul 2018 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 29 Jun 2018 (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 center, single arm, open-lable phase 1 study to determine the safety and efficacy of autologous or donor-derived allogeneic T cells expressing CD19 chimeric antigen receptors (referred to as "CD19-CAR-T cells") in patients with relapsed or refractory acute B-cell lymphoblastic leukemia (R/R B-ALL).
Detailed description
Primary objective:
To investigate the safety and efficacy of autologous or HLA-haploidentical Allo-CD19-CAR-T cells in the treatment of patients with relapsed or refractory acute B-cell lymphoblastic leukemia.
Secondary objective:
To Assess the patient's quality of life after receiving the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CD19-CAR-T Cells | Experimental | Biological: CD19-CAR-T CellsSubjects will receive CD19-CAR-T Cells on Day 0 : 100% of total dose. |
Who may qualify
- Ages
- 3 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Obtain Informed Consent Form (ICF) voluntarily signed by the patient;
- Age 3-70 years old;
- Primary resistant or relapsed B-cell line acute lymphoblastic leukemia;
- B cells are positive for CD19 expression;
- Peripheral blood tumor cell load <50%; 6. KPS score >50 points;
Key exclusion criteria (10 listed)
- Patients with non-B cell acute leukemia;
- Organ failure: Heart: Grade III and IV Liver: Class C with Child-Turcotte liver function classification Kidney: Renal failure and uremia Lung: severe respiratory failure Brain: Disabilities
- Active infection;
- Human immunodeficiency virus (HIV) positive;
- Acute and chronic graft-versus-host disease (GVHD)> Level 1；
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-CAR-T CellsT cells purified from the PBMC of subjects or subjects' relatives which depends on their conditions, transduced with 4-1BB/CD3-ζ lentiviral vector, expanded in vitro for future administration. | Biological | CD19-CAR-T Cells |
Primary outcome
Objective Response Rate, ORR
Time frame: Up to Day90 after the CD19-CAR-T cell infusion
The percentage of participants who achieved complete remission (CR) over all participants (CRR). The percentage of participants who achieved partial remission (PR) over all participants (PRR).
2 secondary outcomes
The amount of CAR-T cells remaining in vivo
Time frame: 2 years after cell infusion.
The lifetime of CAR-T cells remaining in vivo
Time frame: 2 years after cell infusion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2018.
- 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.
Peihua Lu, MD, PhD principal investigator
Hebei Yanda Ludaopei 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 CD19-CAR-T Cells in people with B-cell Acute Lymphoblastic Leukemia, run by Bioceltech Therapeutics, 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 6 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 29 Jun 2018. 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 Zhongwei Xu, MD, Phd (+86 010-69739722, willyxu001@bioceltech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate, ORR (time frame: Up to Day90 after the CD19-CAR-T cell infusion). 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 29 Jun 2018.