Relapsed B-cell Acute Lymphoblastic LeukemiaPhase 2NCT06179524
CAR-T-19 Injection in the Treatment of CD19-positive Relapsed/Refractory B-ALL
A Phase 2 study testing CAR-T-19 cell injection in people with Relapsed B-cell Acute Lymphoblastic Leukemia and Refractory B-cell Acute Lymphoblastic Leukemia, run by Beijing Yongtai Ruike Biotechnology Company Ltd at 1 site in China.
Trial summary
This is a phase II clinical study to evaluate the safety and efficacy of CAR-T-19 injection in the treatment of CD19-positive relapsed/refractory B-cell acute lymphoblastic leukemia. Read more about this study
- Who is it for?
- Ages Up to 25 years
- Conditions the study is for
- Relapsed B-cell Acute Lymphoblastic Leukemia, Refractory B-cell Acute Lymphoblastic Leukemia
- What is being tested?
- CAR-T-19 cell injection
- 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
- 3 Jan 2024to 30 Apr 2027
- Phase
- Phase 2
- 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 Up to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Voluntary participation in clinical trial, The Participants or his legal guardian is fully understands this clinical trial and signs the Informed Consent Form (ICF); Willing to follow and be able to complete all trial procedures.
- Age≤25 years old at the time of screening, regardless of gender.
- Bone marrow examination confirmed the diagnosis of B-ALL, and meet one of the following conditions： Relapsed B-ALL：1）Relapse within 12 months of the first remission；2）Recurrence occurring again more than 12 months after the first remission,, relapsed or not responded after first-line/multi-line salvage chemotherapy；3) Experienced two or more bone marrow recurrences; 4） recurrence after autologous or allogeneic hematopoietic stem cell transplantation； Refractory B-ALL：1）failed to achieve complete remission after 2 cycles of standard induction chemotherapy.
- Ph+ALL patients are eligible：1）Relapsed or refractory after receiving at least two Tyrosine kinase inhibitors (TKI) treatments；If Ph+ALL patients with t315i mutation are resistant to first- and second-generation TKIs, in the absence of effective TKI therapy, patients are not required to receive at least two TKIs；2）cannot tolerate TKI treatment；3）Presence of contraindications to TKI therapy.
- Bone marrow (BM) or peripheral blood (PB) tumor cells were measured to express CD19 at screening.
- Bone marrow blasts ≥ 5% at screening.
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- Adequate organ function and must meet the following criteria： Alanine aminotransferase (ALT) ≤ 5 ×Upper limit of normal value(ULN)；Total serum bilirubin ≤ 2.0 ×ULN(（for Gilbert syndrome, total bilirubin≤3.0×ULN)；in non-oxygen state, No > grade 1 dyspnea, Blood oxygen saturation > 95%；left ventricular ejection fraction(LVEF) ≥ 50%；Serum creatinine≤1.5 × ULN；
- Karnofsky（age≥16 years）performance status≥70 or Lansky（age<16 years）performance status≥50.
- Life expectancy ≥ 12 weeks.
- Adequate venous access (for apheresis) and no other contraindications to apheresis.
- Negative blood/urine pregnancy test in women of childbearing potential before screening and within 3 days prior to cell infusion, and any male and female patients of childbearing potential must agree to use an effective method of contraception throughout the study and for at least 2 years after CAR-T-19 infusion. In the judgment of the investigator, a patient of childbearing potential means that he/she is biologically capable of having children and having a normal sexual life.
- For Participants who have previously undergone allogeneic hematopoietic stem cell transplantation, CAR-T-19 cell preparation is performed using their previous donor peripheral blood， and the donor needs to meet the following conditions：1）Have donated bone marrow/hematopoietic stem cells as a transplant donor for the patient；2）Age ≥8 years at screening；3）Voluntary participation in clinical studies; the donor (and legal guardian, if applicable) am fully aware of and informed about this trial and have signed an informed consent form (ICF); Willing to follow and be able to complete all trial procedures；4）Have adequate venous access (for apheresis or venous blood collection) and no other contraindications to apheresis; 5) The etiological test results do not correspond to any of the exclusion criteria outlined in item 12. 6) Women of childbearing age have negative blood and urine pregnancy tests.7) Systemic glucocorticoid therapy is prohibited within one week prior to apheresis, with the exception of physiologically replacement doses of glucocorticoids (0.5 mg/kg/day of prednisone or equivalent doses of other corticosteroids).8) There are no cases of uncontrolled fungal, bacterial, viral, or other infections requiring intravenous treatment.
Who cannot join
- Isolated extra-medullary disease relapse .
- Participants with genetic syndromes, Patients with Down Syndrome will not be excluded.
- Participants with Burkitt's lymphoma/leukemia.
- Participants with active central nervous system disease.
- Active central nervous system leukemia at screening(Defined as CNS-3 and CNS-2 grades with neurological symptoms as defined by NCCN guidelines and judged by the investigator to be active central leukemia).
- Participants with a history of other malignant tumors or other malignant tumors at the same time (excluding fully treated cervical carcinoma in situ, basal cell or squamous epithelial cell skin cancer, local prostate cancer after radical resection, thyroid cancer, ductal carcinoma in situ after radical resection).
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- have or suspected to have fungal, bacterial, viral or other infections that are uncontrollable or require intravenous treatment.
- Participants who have received HSCT within 3 months before screening or Presence of grade 2 to 4 active graft-versus-host disease (GVHD), and those who have received systemic drug therapy for GVHD within 4 weeks before infusion.
- Received the following anti-tumor therapy before apheresis：1）Received any chemotherapy, targeted therapy, etc. within 4 weeks or at least 5 half-lives (whichever is shorter)；2）Radiotherapy within 14 days；3）Intrathecal treatment within 7 days；4) Received a donor lymphocyte transfusion (DLI) within 4 weeks; 5)Received Blinatumomab within 14 days.
- Participants who have been treated with systemic glucocorticoids within 1 week before apheresis, physiological replacement doses of steroids are allowed.
- Long-acting G-CSF is prohibited within 21 days and short-acting G-CSF is prohibited within 7 days before apheresis.
- Any of the following applies:1）Hepatitis B surface antigen (HBsAg) positive or HBV-DNA quantity is higher than the upper limit of normal value；2）Hepatitis C virus antibody (HCV Ab) is positive and HCV RNA quantification is higher than the upper limit of normal values;3）Positive for human immunodeficiency virus antibody (HIV-Ab);4）EB virus DNA quantification is higher than the upper limit of normal values;5）Cytomegalovirus DNA quantification is higher than the upper limit of normal values.
- Those who have received CAR-T therapy with any target.
- Allergy to albumin and aminoglycoside antibiotics.
- Received live vaccine within 6 weeks before screening.
- Participants after organ transplantation (except hematopoietic stem cell transplantation).
- participated in other interventional clinical studies (received active trial drug treatment) within 3 months before screening, or intend to participate in another clinical trial or receive another anti-tumor therapy.
- Other investigators deem it inappropriate to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Hematology Hospital of the Chinese Academy of Medical Sciences
Tianjin
Xiaofan Zhu, 022-23909137, xfzhu@ihcams.ac.cn
About this study
Official title: Phase II Clinical Study of CAR-T-19 Injection in the Treatment of CD19-positive Relapsed/refractory B-cell Acute Lymphoblastic Leukemia(B-ALL) Under 25 Years of Age (inclusive)
This is a phase II clinical study to evaluate the safety and efficacy of CAR-T-19 injection in the treatment of CD19-positive relapsed/refractory B-cell acute lymphoblastic leukemia.
Read the detailed description
This is a multiple-center, single-arm, open-label study. After meeting the eligibility criteria and enrolling on the trial, patients will undergo leukapheresis for collection of autologous lymphocytes, patients will then proceed to lymphodepleting chemotherapy with cyclophosphamide 300mg/m^2 and fludarabine 30mg/m^2 for 3 consecutive days followed by the infusion of CD19 CAR T-cells at a target dose of 2.5 x10^6 cells/kg（range 0.8-2.5×10^6 cells/kg）.
- Conditions
- Relapsed B-cell Acute Lymphoblastic Leukemia, Refractory B-cell Acute Lymphoblastic Leukemia
- Being tested
- CAR-T-19 cell injection
- Medical subject headings
- Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR-T-19 cell injectionBiological
The functional component of CAR-T-19 cell injection is T cells that have been genetically modified to express anti CD19 chimeric antigen receptors.
| Study group | Role | What they receive |
|---|---|---|
| CAR-T-19 cells | Experimental | CAR-T-19 cells injection: 2.5 x10^6 cells/kg（range 0.8-2.5×10^6 cells/kg） Receives: Biological: CAR-T-19 cell injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate(ORR)
ORR included complete response (CR) and CR with incomplete blood count recovery (CRi) as determined by an Independent Review Committee（IRC） assessment.
Measured: 3 months
Secondary outcomes (22)
ORR
ORR at 3 months after CAR-T-19 infusion as assessed by investigator.
Measured: 3 months
ORR
ORR at 28 days after CAR-T-19 infusion as assessed by IRC and investigator.
Measured: 28 days
Minimal residual disease（MRD）
MRD-negative ORR as assessed by Independent Review Committee (IRC) and investigator.
Measured: 3 months
Best overall response (BOR)
BOR as assessed by Independent Review Committee (IRC) and investigator.
Measured: 2 years
Duration of response (DOR)
DOR as assessed by Independent Review Committee (IRC) and investigator.
Measured: 2 years
Event Free Survival（EFS）
EFS as assessed by Independent Review Committee (IRC) and investigator.
Measured: 2 years
Recurrence Free Survival（RFS）
RFS as assessed by Independent Review Committee (IRC) and investigator.
Measured: 2 years
Overall survival (OS)
Overall survival means the time from infusion of CAR-T-19 cells to death of participants from any cause.
Measured: 2 yeas
AE safety
Number of participants with Adverse event (AE).
Measured: 2 years
SAE safety
Number of participants with Serious adverse event (SAE)
Measured: 2 years
ADA safety
Number of participants with Anti-drug antibody(ADA).
Measured: 2 years
RCL safety
Number of participants with Replication Competent Lentivirus (RCL).
Measured: 15 years
Pharmacokinetics (PK) Parameter-Cmax
Cmax
Measured: 2 years
Pharmacokinetics (PK) Parameter-Tmax
Tmax
Measured: 2 years
Pharmacokinetics (PK) Parameter-AUC0-t
AUC0-t
Measured: 2 years
Pharmacokinetics (PK) Parameter- AUC0-28d
AUC0-28d
Measured: 2 years
Pharmacokinetics (PK) Parameter- t1/2
t1/2
Measured: 2 years
Pharmacodynamics
The degree of clearance of CD19-positive B cells at different blood collection time points after cell infusion.
Measured: 2 years
Serum cytokines-Interleukin 6
The concentration levels of Interleukin 6（ IL-6）at each time point .
Measured: 28 days
Serum cytokines-Interleukin 10
The concentration levels of Interleukin 10（ IL-10）at each time point .
Measured: 28 days
Serum cytokines-TNF-α
The concentration levels of tumor necrosis factor -α（ TNF-α） at each time point .
Measured: 28 days
Serum cytokines-INF-γ
The concentration levels of Interferon -γ（INF-γ） at each time point .
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2023
- Study start3 Jan 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Yongtai Ruike Biotechnology Company Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiaofan Zhu, Principal investigator, Hematology Hospital of the Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06179524
- Sponsor's protocol ID
- CT19-ALL-02
- Status last verified
- Dec 2024
- First submitted
- 1 Dec 2023
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- 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 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Study of CAR-T-19 Injection in the Treatment of CD19-positive Relapsed/refractory B-cell Acute Lymphoblastic Leukemia(B-ALL) Under 25 Years of Age (inclusive)
- ClinicalTrials.gov ID
- NCT06179524
- Acronym / sponsor ID
- CT19-ALL-02
- Conditions
- Relapsed B-cell Acute Lymphoblastic Leukemia, Refractory B-cell Acute Lymphoblastic Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Beijing Yongtai Ruike Biotechnology Company LtdIndustry (pharma, biotech, devices)
- Study start
- 3 Jan 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 22 Dec 2023 (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 II clinical study to evaluate the safety and efficacy of CAR-T-19 injection in the treatment of CD19-positive relapsed/refractory B-cell acute lymphoblastic leukemia.
Detailed description
This is a multiple-center, single-arm, open-label study. After meeting the eligibility criteria and enrolling on the trial, patients will undergo leukapheresis for collection of autologous lymphocytes, patients will then proceed to lymphodepleting chemotherapy with cyclophosphamide 300mg/m^2 and fludarabine 30mg/m^2 for 3 consecutive days followed by the infusion of CD19 CAR T-cells at a target dose of 2.5 x10^6 cells/kg（range 0.8-2.5×10^6 cells/kg）.
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 cell injectionCAR-T-19 cells injection: 2.5 x10^6 cells/kg（range 0.8-2.5×10^6 cells/kg） |
Who may qualify
- Ages
- Up to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- Voluntary participation in clinical trial, The Participants or his legal guardian is fully understands this clinical trial and signs the Informed Consent Form (ICF); Willing to follow and be able to complete all trial procedures.
- Age≤25 years old at the time of screening, regardless of gender.
- Bone marrow examination confirmed the diagnosis of B-ALL, and meet one of the following conditions： Relapsed B-ALL：1）Relapse within 12 months of the first remission；2）Recurrence occurring again more than 12 months after the first remission,, relapsed or not responded after first-line/multi-line salvage chemotherapy；3) Experienced two or more bone marrow recurrences; 4） recurrence after autologous or allogeneic hematopoietic stem cell transplantation； Refractory B-ALL：1）failed to achieve complete remission after 2 cycles of standard induction chemotherapy.
- Ph+ALL patients are eligible：1）Relapsed or refractory after receiving at least two Tyrosine kinase inhibitors (TKI) treatments；If Ph+ALL patients with t315i mutation are resistant to first- and second-generation TKIs, in the absence of effective TKI therapy, patients are not required to receive at least two TKIs；2）cannot tolerate TKI treatment；3）Presence of contraindications to TKI therapy.
- Bone marrow (BM) or peripheral blood (PB) tumor cells were measured to express CD19 at screening.
Key exclusion criteria (18 listed)
- Isolated extra-medullary disease relapse .
- Participants with genetic syndromes, Patients with Down Syndrome will not be excluded.
- Participants with Burkitt's lymphoma/leukemia.
- Participants with active central nervous system disease.
- Active central nervous system leukemia at screening(Defined as CNS-3 and CNS-2 grades with neurological symptoms as defined by NCCN guidelines and judged by the investigator to be active central leukemia).
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 cell injectionThe functional component of CAR-T-19 cell injection is T cells that have been genetically modified to express anti CD19 chimeric antigen receptors. | Biological | CAR-T-19 cells |
Primary outcome
Objective response rate(ORR)
Time frame: 3 months
ORR included complete response (CR) and CR with incomplete blood count recovery (CRi) as determined by an Independent Review Committee（IRC） assessment.
22 secondary outcomes
ORR
Time frame: 3 months
ORR
Time frame: 28 days
Minimal residual disease（MRD）
Time frame: 3 months
Best overall response (BOR)
Time frame: 2 years
Duration of response (DOR)
Time frame: 2 years
Event Free Survival（EFS）
Time frame: 2 years
Recurrence Free Survival（RFS）
Time frame: 2 years
Overall survival (OS)
Time frame: 2 yeas
AE safety
Time frame: 2 years
SAE safety
Time frame: 2 years
ADA safety
Time frame: 2 years
RCL safety
Time frame: 15 years
Pharmacokinetics (PK) Parameter-Cmax
Time frame: 2 years
Pharmacokinetics (PK) Parameter-Tmax
Time frame: 2 years
Pharmacokinetics (PK) Parameter-AUC0-t
Time frame: 2 years
Pharmacokinetics (PK) Parameter- AUC0-28d
Time frame: 2 years
Pharmacokinetics (PK) Parameter- t1/2
Time frame: 2 years
Pharmacodynamics
Time frame: 2 years
Serum cytokines-Interleukin 6
Time frame: 28 days
Serum cytokines-Interleukin 10
Time frame: 28 days
Serum cytokines-TNF-α
Time frame: 28 days
Serum cytokines-INF-γ
Time frame: 28 days
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 13 Jan 2025.
- 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.
Xiaofan Zhu principal investigator
Hematology Hospital of the Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CAR-T-19 cell injection in people with Relapsed B-cell Acute Lymphoblastic Leukemia and Refractory B-cell Acute Lymphoblastic Leukemia, run by Beijing Yongtai Ruike Biotechnology Company 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 12 inclusion and 18 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 13 Jan 2025. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Xiaofan Zhu (022-23909137, xfzhu@ihcams.ac.cn), 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: 3 months). 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 13 Jan 2025.