Relapsed or Refractory Acute Lymphoblastic LeukemiaPhase 2NCT06367114
Clinical Trial of ssCART-19 Cell Injection in the Treatment of Relapsed or Refractory Acute Lymphoblastic Leukemia (Including Central Nervous System Infiltration)
A Phase 2 study testing ssCART-19, Fludarabine and Cyclophosphamide in people with Relapsed or Refractory Acute Lymphoblastic Leukemia, run by Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd at 2 sites in China.
Trial summary
This study is a Phase II, single-arm, open-label, non-randomized, dose-escalation clinical trial to evaluate the efficacy and safety of ssCART-19 Cell Injection in the treatment of patients with CD19 positive Relapsed or Refractory acute lymphoblastic leukemia, including central nervous system infiltration. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Relapsed or Refractory Acute Lymphoblastic Leukemia
- What is being tested?
- ssCART-19, Fludarabine and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesChina
- Study dates
- Apr 2024to Dec 2025
- Phase
- Phase 2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent is signed by the subject.
- Age 18 to 65.
- Relapsed or refractory acute lymphoblastic leukemia (ALL), According to the Chinese Guidelines for the Diagnosis and Treatment of Acute Lymphoblastic Leukemia in Adults (2021) those who need to fulfill one of the following conditions: (1)refractory leukemia: failure to reach CR/CRi after standard induction therapy (generally referred to as the 4-week regimen or Hyper-CVAD regimen). (2) Recurrence of leukemia: patients who have already reached CR have primitive cells in their peripheral blood or bone marrow (proportion>5%). (3)Patients with Ph+ ALL are eligible if they do not reach CR after at least two lines of TKI therapy or relapse after CR (except those who are intolerant to TKI therapy, have contraindications to TKI therapy or have T315i mutations). (4)Relapse after autologous or allogeneic hematopoietic stem cell transplantation(HSCT).
- Bone marrow with ≥ 5% lymphoblasts by morphologic assessment at screening (morphological examination)
- CD19 tumor expression demonstrated in bone marrow by flow cytometry
- Eastern cooperative oncology group (ECOG) performance status of 0 to 1.
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- Adequate organ function at screening defined as: a.Left ventricular ejection fraction ≥ 50% by echocardiogram. b.Creatinine ≤1.5× upper limit of normal (ULN), or creatinine clearance ≥ 60 mL/min (Cockcroft and Gault). c.ALT and AST≤3×ULN, total bilirubin ≤2×ULN. d.dyspnea (CTCAE v5.0) ≤ grade 1 (shortness of breath during moderate activity) and blood oxygen saturation > 91% without oxygen inhalation as determined by investigators.
- Vascular conditions for apheresis.
- Females of childbearing potential who have a negative pregnancy test by blood human chorionic gonadotropin (HCG) (immunofluorescence) during the screening period and who agree to use effective contraception for at least 1 year after the infusion; male subjects whose partner is a female of childbearing potential must agree to use an effective barrier method of contraception for at least 1 year after the infusion and to refrain from sperm donation
- The estimated survival time is more than 3 months
Who cannot join
- Isolated extra-medullary disease relapse (except central nervous system infiltration).
- Presence of other tumors that have not been eradicated within 5 years prior to screening that the investigator assesses may have a potential impact on the tumor.
- Has past or at screening CNS diseases other than this disease, such as epilepsy, cerebrovascular ischemia/hemorrhage, dementia, cerebellar diseases or any CNS-related autoimmune diseases.
- Has had treatment with any prior anti-CD19 therapy, except for leukemia cells with a positive proportion of CD19 ≥80%.
- Therapeutic systemic doses of hormone were stopped < 72 hours prior to apheresis. However, the following physiological replacement doses of hormone are allowed: < 10 mg/day prednisone or equivalent amounts of other steroid hormones.
- Received donor lymphocyte infusion (DLI) within 6 weeks prior to ssCART-19 infusion
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- Radiotherapy before ssCART-19 infusion:Non-CNS site of radiation completed < 2 weeks prior to ssCART-19 Infusion; CNS directed radiation completed < 8 weeks prior to ssCART-19 infusion.
- Has had treatment with any anti-T cell antibody therapy within 4 weeks prior to monocyte collection.
- Patients complying with any of hepatitis B surface antigen (HBsAg) and/or hepatitis B e antigen (HBeAg) positive, hepatitis B e antibody (HBe-Ab) and/or hepatitis B core antibody (HBc-Ab) positive and HBV-DNA copies being more than the lower limit of detection, hepatitis C antibody (HCV-Ab) positive, and HCV-DNA copies being more than the lower limit of detection, anti-treponemia pallidum antibody (TP-Ab) positive, human immunodeficiency virus (HIV) antibody positive, EBV-DNA, and CMV-DNA copies being more than the lower limit of detection.
- Patients with active infections or uncontrolled infections that required systemic treatment in screening (except for mild genitourinary infections and upper respiratory infections).
- Prior to signing the informed consent, have had cardiac angioplasty or stent placement within 12 months, or have had III-IV congestive heart failure (NYHA), or have had myocardial infarction, unstable angina, or other heart disease determined by the investigator to be ineligible for enrollment within 6 months, or QTc interval ≥480ms (QTc interval calculated by Fridericia formula) during screening, Hypertension that has not been controlled after standard treatment (systolic ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg) or pulmonary hypertension.
- Patients have systemic diseases as judged by investigators to be unstable: including, but not limited to, severe liver, kidney, or metabolic diseases requiring medical treatment.
- Patients with active or uncontrolled autoimmune disease, primary or secondary immunodeficiency.
- Has had severe immediate hypersensitivity reaction to any drug to be used in this study.
- Has had treat with live vaccine within 6 weeks prior to screening.
- Pregnant or lactating women.
- A history of autoimmune diseases (e. g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) requiring systemic immunosuppressive/systemic disease modifying medications within the past 2 years
- Patients with a history of allogeneic hematopoietic stem cell transplantation within 12 weeks prior to apheresis, acute graft-versus-host disease (GVHD) or moderate to severe chronic GVHD within 4 weeks prior to screening; Patients who received systemic drug therapy for GVHD within 4 weeks prior to infusion.
- Participating in any other study and have received any other investigational drug within 4 weeks prior to screening.
- Patients with other conditions making the patients unsuitable for this study as judged by the investigator.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Shanghai Unicar-Therapy Bio-medicine Technology Co., Ltd.
Shanghai, Shanghai Municipality, 201210
The First Affiliated Hospital of Soochow University
Suzhou
Depei Wu, Dr.
About this study
Official title: Phase Ⅱ Clinical Trial of ssCART-19 Cell Injection in the Treatment of CD19 Positive Relapsed or Refractory Acute Lymphoblastic Leukemia (Including Central Nervous System Infiltration)
This study is a Phase II, single-arm, open-label, non-randomized, dose-escalation clinical trial to evaluate the efficacy and safety of ssCART-19 Cell Injection in the treatment of patients with CD19 positive Relapsed or Refractory acute lymphoblastic leukemia, including central nervous system infiltration.
Read the detailed description
This study is a Phase II, single-arm, open-label, non-randomized, dose-escalation clinical trial to evaluate the efficacy and safety of ssCART-19 Cell Injection in the treatment of patients with CD19 positive Relapsed or Refractory acute lymphoblastic leukemia, including central nervous system infiltration. The study consists of screening period (8 weeks), treatment period (4 weeks), and follow-up period. All subjects who have received ssCART-19 infusion will be followed for safety and efficacy up to 2 years.
- Being tested
- ssCART-19, Fludarabine, Cyclophosphamide
- Medical subject headings
- Recurrence, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ssCART-19Biological
Split-Dose of ssCART-19 cells will be infused, and classic "3+3" dose escalation will be applied.
FludarabineDrug
Fludarabine is used for lymphodepletion.
CyclophosphamideDrug
Cyclophosphamide is used for lymphodepletion.
| Study group | Role | What they receive |
|---|---|---|
| ssCART-19 Cells | Experimental | Route of administration: Intravenous injection.
Lymphodepletion conditioning:
Lymphodepletion will be conducted several days prior to ssCART-19 cells infusion.
A combination of fludarabine and cyclophosphamide will be used for lymphodepletion. Receives: Biological: ssCART-19; Drug: Fludarabine; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the efficacy of ssCART-19 cells in patients with CD19-positive relapsed or refractory acute B lymphoblastic leukemia (r/r B-ALL).
Overall Remission Rate (ORR), which includes Complete Remission (CR) and complete remission with partial hematologic recovery (CRh) and Complete Remission with Incomplete Blood Count Recovery (CRi) as determined by Independent Review Committee (IRC).
Measured: At 3 months after infusion
Secondary outcomes (10)
Observe the anti-tumor response of ssCART-19 cells to refractory or relapsed acute lymphoblastic leukemia.
Overall remission rate (ORR) with negative micro residual disease (MRD) within 3 months after ssCART-19 infusion.
Measured: 3 months
Best overall response (BOR)assessment during the 3 months after ssCART-19 infusion.
The proportion of patients who have achieved the best effect (CR or CRi) after the experimental treatment.
Measured: 3 months
Duration of response (DOR)
DOR means the duration from reaching the response CR or CRi to the first defined relapse, or death due to any cause, whichever comes first.
Measured: 24 months
Recurrence free survival (RFS)
RFS means the duration from reaching the response CR or CRi to the first defined relapse, or death due to any cause, whichever comes first.
Measured: 24 months
Event Free Survival (EFS)
EFS means duration from the ssCART-19 Cell Injection infusion to death for any reason after remission, relapse, treatment failure, no response, or termination (because of death, adverse event, lack of efficacy, progression, new anti-tumor treatments.
Measured: 24 months
Overall survival (OS)
OS is defined as the time from the ssCART-19 Cell Injection infusion to the date of death due to any cause.
Measured: 24 months
Incidence of adverse events following ssCART-19 infusion
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) Dose-limiting toxicity after ssCART-19 infusion.
Measured: 24 months
Pharmacodynamic of ssCART-19 cells
Peak value of eripheral blood (Cmax)
Measured: 28 days
Pharmacodynamic of ssCART-19 cells
Area under the eripheral blood concentration versus time curve (AUC)
Measured: 28 days
Pharmacodynamic of ssCART-19 cells
Time of peak value
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 posted16 Apr 2024
- Study startApr 2024 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Soochow University, Peking University People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06367114
- Sponsor's protocol ID
- ssCART-19-II-1
- Status last verified
- Apr 2024
- First submitted
- 3 Apr 2024
- Last updated
- 19 Apr 2024
- 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 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ⅱ Clinical Trial of ssCART-19 Cell Injection in the Treatment of CD19 Positive Relapsed or Refractory Acute Lymphoblastic Leukemia (Including Central Nervous System Infiltration)
- ClinicalTrials.gov ID
- NCT06367114
- Acronym / sponsor ID
- ssCART-19-II-1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shanghai Unicar-Therapy Bio-medicine Technology Co.,LtdIndustry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Soochow University, Peking University People's Hospital
- Study start
- Apr 2024 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 16 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.
This study is a Phase II, single-arm, open-label, non-randomized, dose-escalation clinical trial to evaluate the efficacy and safety of ssCART-19 Cell Injection in the treatment of patients with CD19 positive Relapsed or Refractory acute lymphoblastic leukemia, including central nervous system infiltration.
Detailed description
This study is a Phase II, single-arm, open-label, non-randomized, dose-escalation clinical trial to evaluate the efficacy and safety of ssCART-19 Cell Injection in the treatment of patients with CD19 positive Relapsed or Refractory acute lymphoblastic leukemia, including central nervous system infiltration. The study consists of screening period (8 weeks), treatment period (4 weeks), and follow-up period. All subjects who have received ssCART-19 infusion will be followed for safety and efficacy up to 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ssCART-19 Cells | Experimental | Biological: ssCART-19, Drug: Fludarabine, Drug: CyclophosphamideRoute of administration: Intravenous injection. Lymphodepletion conditioning: Lymphodepletion will be conducted several days prior to ssCART-19 cells infusion. A combination of fludarabine and cyclophosphamide will be used for lymphodepletion. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Informed consent is signed by the subject.
- Age 18 to 65.
- Relapsed or refractory acute lymphoblastic leukemia (ALL), According to the Chinese Guidelines for the Diagnosis and Treatment of Acute Lymphoblastic Leukemia in Adults (2021) those who need to fulfill one of the following conditions: (1)refractory leukemia: failure to reach CR/CRi after standard induction therapy (generally referred to as the 4-week regimen or Hyper-CVAD regimen). (2) Recurrence of leukemia: patients who have already reached CR have primitive cells in their peripheral blood or bone marrow (proportion>5%). (3)Patients with Ph+ ALL are eligible if they do not reach CR after at least two lines of TKI therapy or relapse after CR (except those who are intolerant to TKI therapy, have contraindications to TKI therapy or have T315i mutations). (4)Relapse after autologous or allogeneic hematopoietic stem cell transplantation(HSCT).
- Bone marrow with ≥ 5% lymphoblasts by morphologic assessment at screening (morphological examination)
- CD19 tumor expression demonstrated in bone marrow by flow cytometry
Key exclusion criteria (20 listed)
- Isolated extra-medullary disease relapse (except central nervous system infiltration).
- Presence of other tumors that have not been eradicated within 5 years prior to screening that the investigator assesses may have a potential impact on the tumor.
- Has past or at screening CNS diseases other than this disease, such as epilepsy, cerebrovascular ischemia/hemorrhage, dementia, cerebellar diseases or any CNS-related autoimmune diseases.
- Has had treatment with any prior anti-CD19 therapy, except for leukemia cells with a positive proportion of CD19 ≥80%.
- Therapeutic systemic doses of hormone were stopped < 72 hours prior to apheresis. However, the following physiological replacement doses of hormone are allowed: < 10 mg/day prednisone or equivalent amounts of other steroid hormones.
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 |
|---|---|---|
| ssCART-19Split-Dose of ssCART-19 cells will be infused, and classic "3+3" dose escalation will be applied. | Biological | ssCART-19 Cells |
| FludarabineFludarabine is used for lymphodepletion. | Drug | ssCART-19 Cells |
| CyclophosphamideCyclophosphamide is used for lymphodepletion. | Drug | ssCART-19 Cells |
Primary outcome
Determine the efficacy of ssCART-19 cells in patients with CD19-positive relapsed or refractory acute B lymphoblastic leukemia (r/r B-ALL).
Time frame: At 3 months after infusion
Overall Remission Rate (ORR), which includes Complete Remission (CR) and complete remission with partial hematologic recovery (CRh) and Complete Remission with Incomplete Blood Count Recovery (CRi) as determined by Independent Review Committee (IRC).
10 secondary outcomes
Observe the anti-tumor response of ssCART-19 cells to refractory or relapsed acute lymphoblastic leukemia.
Time frame: 3 months
Best overall response (BOR)assessment during the 3 months after ssCART-19 infusion.
Time frame: 3 months
Duration of response (DOR)
Time frame: 24 months
Recurrence free survival (RFS)
Time frame: 24 months
Event Free Survival (EFS)
Time frame: 24 months
Overall survival (OS)
Time frame: 24 months
Incidence of adverse events following ssCART-19 infusion
Time frame: 24 months
Pharmacodynamic of ssCART-19 cells
Time frame: 28 days
Pharmacodynamic of ssCART-19 cells
Time frame: 28 days
Pharmacodynamic of ssCART-19 cells
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ssCART-19, Fludarabine and Cyclophosphamide in people with Relapsed or Refractory Acute Lymphoblastic Leukemia, run by Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd 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 10 inclusion and 20 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 19 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaoyan Lou, Dr. (18721281671, xiaoyan.lou@unicar-therapy.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the efficacy of ssCART-19 cells in patients with CD19-positive relapsed or refractory acute B lymphoblastic leukemia (r/r B-ALL). (time frame: At 3 months after 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 19 Apr 2024.