B Lymphocytic LeukemiaNCT06355739
CD19-targeted CAR T Cell Autotransfusion for the Treatment of Recurrent/Refractory B-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma in Children With CD19+
A study testing CAR T cell injection in people with B Lymphocytic Leukemia and B Lymphoblastic Lymphoma, run by Zhu Xiaofan at 2 sites in China.
Trial summary
To evaluate the safety and efficacy of BIC-19GG, BIC-2019, BIC-2219 in the treatment of relapsed/refractory B acute lymphoblastic leukemia/lymphoblastic lymphoma in children Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- B Lymphocytic Leukemia, B Lymphoblastic Lymphoma
- What is being tested?
- CAR T cell injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- 1 Feb 2024to 15 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 1, age 3-18 years old (including boundary value), male and female;
- 2. The patient was clinically diagnosed as relapsed/refractory B acute lymphoblastic leukemia/lymphoblastic lymphoblastic
- Patients with tumors who meet one of the following conditions:
- Complete marrow response (MRD>1%) or not achieved after at least 2 courses of standardized induction regimen chemotherapy
- Complete response at the molecular level and immunology (characterized by specific molecular markers and immunophenotypes prior to treatment)
- Patients, did not turn negative after treatment);
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- Recurrence during chemotherapy, early recurrence after drug withdrawal (<12 months) or late recurrence after complete remission (≥
- 12 months) and did not achieve complete remission after 1 course of standard induction regimen (MRD>1%);
- Recurrence after bone marrow transplantation;
- Simple bone marrow, simple extramedullary (testicular leukemia, central nervous system leukemia) or combined
- recrudescence
- 3. Lansky score ≥60;
- 4, the treatment related antigen test result is positive (CD19/CD20/CD22);
- 5. The expected survival period from the signing date of the informed consent is more than 3 months;
- 6, HGB≥70g/L (blood transfusion);
- 7, liver and kidney function, cardiopulmonary function meet the following requirements:
- Creatinine ≤1.5×ULN;
- Left ventricular ejection fraction ≥50%;
- Blood oxygen saturation >90%;
- Total bilirubin ≤1.5×ULN; ALT and AST≤2.5 x ULN.-
Who cannot join
- 1, severe cardiac insufficiency, left ventricular ejection fraction <50%;
- 2, have a history of severe lung function impairment;
- 3. Combined with other advanced malignant tumors;
- 4, combined with serious infection and can not be effectively controlled;
- 5, combined with serious autoimmune disease or congenital immune deficiency;
- 6, active hepatitis (hepatitis B virus deoxyribonucleic acid [HBVDNA] or hepatitis C virus ribonucleic acid [HCVRNA] positive);
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- 7, human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection;
- 8. Have a history of severe allergy to biological products (including antibiotics);
- 9. Patients with allogeneic hematopoietic stem cell transplantation still had acute graft-versus-host response (GvHD) one month after immunosuppressant discontinuation;
- 10, the presence of other serious physical or mental illnesses or abnormalities in laboratory tests that may increase the risk of participating in the study or interfere with the study results, as well as patients deemed unsuitable for participation in the study by the investigator.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Department of Pediatrics, Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300020
Xiaofan Zhu, MD, 86-21-23909001, xfzhu@ihcams.ac.cn
Jingliao Zhang, MD
- Not yet recruiting
InstituteHBDH
Tianjin, Tianjin Municipality, 300020
Zhu Xiaofan, 86-21-23909001, xfzhu@ihcams.ac.cn
Guo Ye
About this study
Official title: Phase II Clinical Study on the Safety and Efficacy of Autotransfusion Agents Targeting CD19 Chimeric Antigen Receptor T Lymphocytes (BIC-19GG, BIC-2019,BIC-2219)in the Treatment of CD19-positive Children With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma
To evaluate the safety and efficacy of BIC-19GG, BIC-2019, BIC-2219 in the treatment of relapsed/refractory B acute lymphoblastic leukemia/lymphoblastic lymphoma in children
- Conditions
- B Lymphocytic Leukemia, B Lymphoblastic Lymphoma
- Being tested
- CAR T cell injection
- Medical subject headings
- Leukemia, B-Cell, Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR T cell injectionDevice
intravenous injection
| Study group | Role | What they receive |
|---|---|---|
| CD19 autotransfusion for B-cell acute lymphoblastic leukemia in children | Other | Not described Receives: Device: CAR T cell injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival and event-free survival
The prognosis of ALL children who underwent CAR-T cell therapy
Measured: 24 months post CAR-T cell infusion
Secondary outcomes (2)
Overall remission rate
The ORR of ALL children who underwent CAR-T cell therapy
Measured: One month post CAR-T cell infusion
Adverse events
Incidence of adverse events and its severity
Measured: 12 months post CAR-T cell infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start1 Feb 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B Lymphocytic 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhu Xiaofan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhu Xiaofan, Institute of Hematology & Blood Diseases Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06355739
- Sponsor's protocol ID
- BIC-19GG, BIC-2019,BIC-2219
- Status last verified
- Apr 2024
- First submitted
- 2 Feb 2024
- Last updated
- 9 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Study on the Safety and Efficacy of Autotransfusion Agents Targeting CD19 Chimeric Antigen Receptor T Lymphocytes (BIC-19GG, BIC-2019,BIC-2219)in the Treatment of CD19-positive Children With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma
- ClinicalTrials.gov ID
- NCT06355739
- Acronym / sponsor ID
- BIC-19GG, BIC-2019,BIC-2219
- Conditions
- B Lymphocytic Leukemia, B Lymphoblastic Lymphoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zhu XiaofanUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 9 Apr 2024 (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.
To evaluate the safety and efficacy of BIC-19GG, BIC-2019, BIC-2219 in the treatment of relapsed/refractory B acute lymphoblastic leukemia/lymphoblastic lymphoma in children
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CD19 autotransfusion for B-cell acute lymphoblastic leukemia in children | Other | Device: CAR T cell injection |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (20 listed)
- 1, age 3-18 years old (including boundary value), male and female;
- 2. The patient was clinically diagnosed as relapsed/refractory B acute lymphoblastic leukemia/lymphoblastic lymphoblastic
- Complete marrow response (MRD>1%) or not achieved after at least 2 courses of standardized induction regimen chemotherapy
- Complete response at the molecular level and immunology (characterized by specific molecular markers and immunophenotypes prior to treatment)
- Patients, did not turn negative after treatment);
Key exclusion criteria (10 listed)
- 2, have a history of severe lung function impairment;
- 3. Combined with other advanced malignant tumors;
- 4, combined with serious infection and can not be effectively controlled;
- 5, combined with serious autoimmune disease or congenital immune deficiency;
- 6, active hepatitis (hepatitis B virus deoxyribonucleic acid [HBVDNA] or hepatitis C virus ribonucleic acid [HCVRNA] positive);
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 cell injectionintravenous injection | Device | CD19 autotransfusion for B-cell acute lymphoblastic leukemia in children |
Primary outcome
Overall survival and event-free survival
Time frame: 24 months post CAR-T cell infusion
The prognosis of ALL children who underwent CAR-T cell therapy
2 secondary outcomes
Overall remission rate
Time frame: One month post CAR-T cell infusion
Adverse events
Time frame: 12 months post CAR-T cell infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Department of Pediatrics, Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences
Tianjin, China
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAR T cell injection in people with B Lymphocytic Leukemia and B Lymphoblastic Lymphoma, run by Zhu Xiaofan at 2 sites 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 20 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: looking for participants now, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival and event-free survival (time frame: 24 months post 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 9 Apr 2024.