Relapsed or Refractory Acute Lymphoblastic LeukemiaPhase 1NCT04825496
Clinical Study of ssCART-19 Cells in Patients With CD19 Positive Relapsed or Refractory Acute Lymphoblastic Leukemia
A Phase 1 study testing ssCART-19 Cells, Fludarabine and Cyclophosphamide in people with Relapsed or Refractory Acute Lymphoblastic Leukemia, run by Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd at 1 site in China.
Trial summary
This is a single arm, open-label, non-randomized, dose-escalation, phase I study to determine the safety and efficacy of ssCART-19 in the treatment of patients with CD19 positive relapsed or refractory acute lymphoblastic leukemia. 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 Cells, Fludarabine and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 9 Apr 2021to 31 Dec 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Relapsed or refractory acute lymphoblastic leukemia (ALL):(1)Any Relaps after first remission OR (2)Any BM relapse after allogeneic SCT and must be ≥ 3 months from SCT at the time of ssCART-19 infusion OR (3)failed to reach CR after 2 cycles of induction chemotherapy regimen OR (4)Patients with Ph+ ALL are eligible if they are intolerant to or have failed two lines of TKI therapy, or if TKI therapy is contraindicated
- CD19 tumor expression demonstrated in bone marrow or peripheral blood by flow cytometry
- Bone marrow with ≥ 5% lymphoblasts by morphologic assessment
- Adequate organ function defined as:(1)left ventricular ejection fraction ≥ 50% by echocardiogram；(2)creatinine ≤ 1.6mg/dl；(3)ALT and AST≤3 times the ULN for age, total bilirubin ≤ 2.0mg/dl；(4)Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygenation > 91% on room air
- Informed consent is signed by the subject
- Age 18 to 65
Show all 11Show fewer
- Fertility of men, to ensure that sexual partners can effectively contraception; Women with fertility use effective contraceptive measures and agree to use contraceptive measures throughout the study period
- Qualified T cell amplification
- Eastern cooperative oncology group (ECOG) performance status of 0 to 1
- Vascular conditions for apheresis
- The estimated survival time is more than 3 months
Who cannot join
- Isolated extra-medullary disease relapse
- Combined with other malignant tumors
- Has had treatment with any prior anti-CD19/anti-CD3 therapy, or any other antiCD19 therapy
- Has had immunosuppressants or hormones within 2 weeks before signing informed consent, or plan to use immunosuppressants or hormones after signing informed consent
- 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, anti-treponemia pallidum antibody (TP-Ab) positive, EBV-DNA, and CMV-DNA copies being more than the lower limit of detection
- Has uncontrolled bacteria, fungi, viruses, mycoplasma or other types of infections
Show all 18Show fewer
- Infected with HIV, syphilis or COVID-19
- Has a history of severe immediate hypersensitivity to aminoglycosides
- Has past or present CNS diseases, such as epilepsy, cerebrovascular ischemia/hemorrhage, dementia, cerebellar diseases or any CNS-related autoimmune diseases
- Has undergone cardiac angioplasty or stent implantation within 12 months before signing informed consent, or having a history of myocardial infarction, unstable angina pectoris or other clinically significant heart diseases
- With primary 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
- Has active autoimmune diseases
- Has active acute or chronic graft-versus-host disease (GVHD) before signing informed consent
- Patient has an investigational medicinal product within 3 months before signing informed consent
- Patients with other conditions making the patients unsuitable for receiving cell therapy as judged by the investigator
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Unicar-Therapy Bio-medicine Technology Co., Ltd.
Shanghai, Shanghai Municipality, 201210
Xiaoyan Lou, Dr., 18721281671, xiaoyan.lou@unicar-therapy.com
Liqing Kang, Dr., 13162512992, liqing.kang@unicar-therapy.com
About this study
This is a single arm, open-label, non-randomized, dose-escalation, phase I study to determine the safety and efficacy of ssCART-19 in the treatment of patients with CD19 positive relapsed or refractory acute lymphoblastic leukemia.
Read the detailed description
This is a single arm, open-label, non-randomized, dose-escalation, phase I study to determine the safety and efficacy of ssCART-19 in the treatment of patients with CD19 positive relapsed or refractory acute lymphoblastic leukemia.
Primary objectives:
Determine the safety and tolerability of ssCART-19 cells in patients with refractory or relapsed acute lymphoblastic leukemia.
Secondary objectives:
- Observe the anti-tumor response of ssCART-19 cells to refractory or relapsed acute lymphoblastic leukemia.
- Overall remission rate (ORR) assessment during the 3 months after ssCART-19 administration，ORR includes CR and CRi
- Duration of response (DOR)
- Progression-free survival (PFS)
- Overall survival (OS)
- To characterize the in vivo cellular pharmacokinetic (PK) profile of ssCART-19 cells.
- To characterize the pharmacodynamic (PD) profile of ssCART-19 cells.
- Being tested
- ssCART-19 Cells, 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-19 CellsGenetic
Split-Dose of ssCART-19 cells will be infused, and classic "3+3" dose escalation will be applied.
FludarabineDrug
Also called FA
Fludarabine is used for lymphodepletion.
CyclophosphamideDrug
Also called CTX
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: Genetic: ssCART-19 Cells; Drug: Fludarabine; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity (DLT)
Determine the safety and tolerability of ssCART-19 in patients with refractory or relapsed acute lymphoblastic leukemia.
Safety measures include adverse events as assessed by CTCAE v5.0.
Measured: 28 days
Secondary outcomes (4)
Overall Remission Rate (ORR), which includes Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi)
Efficacy of ssCART-19 as measured by ORR during the 3 months after ssCART-19 infusion, which includes CR and CRi.
Measured: 3 months
Duration of remission (DOR)
Statistical parameter:Duration of remission (DOR)
Measured: 24 months
Progression-free Survival (PFS)
Statistical parameter:Progression-free Survival (PFS)
Measured: 24 months
Overall survival (OS)
Statistical parameter:Overall survival (OS)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start9 Apr 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04825496
- Sponsor's protocol ID
- ssCART-19
- Status last verified
- May 2023
- First submitted
- 28 Mar 2021
- Last updated
- 21 Sep 2023
- 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 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of ssCART-19 Cells in Patients With CD19 Positive Relapsed or Refractory Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT04825496
- Acronym / sponsor ID
- ssCART-19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Shanghai Unicar-Therapy Bio-medicine Technology Co.,LtdIndustry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Soochow University
- Study start
- 9 Apr 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 1 Apr 2021 (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, non-randomized, dose-escalation, phase I study to determine the safety and efficacy of ssCART-19 in the treatment of patients with CD19 positive relapsed or refractory acute lymphoblastic leukemia.
Detailed description
This is a single arm, open-label, non-randomized, dose-escalation, phase I study to determine the safety and efficacy of ssCART-19 in the treatment of patients with CD19 positive relapsed or refractory acute lymphoblastic leukemia.
Primary objectives:
Determine the safety and tolerability of ssCART-19 cells in patients with refractory or relapsed acute lymphoblastic leukemia.
Secondary objectives:
- Observe the anti-tumor response of ssCART-19 cells to refractory or relapsed acute lymphoblastic leukemia.
- Overall remission rate (ORR) assessment during the 3 months after ssCART-19 administration，ORR includes CR and CRi
- Duration of response (DOR)
- Progression-free survival (PFS)
- Overall survival (OS)
- To characterize the in vivo cellular pharmacokinetic (PK) profile of ssCART-19 cells.
- To characterize the pharmacodynamic (PD) profile of ssCART-19 cells.
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 | Genetic: ssCART-19 Cells, 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 (11 listed)
- Relapsed or refractory acute lymphoblastic leukemia (ALL):(1)Any Relaps after first remission OR (2)Any BM relapse after allogeneic SCT and must be ≥ 3 months from SCT at the time of ssCART-19 infusion OR (3)failed to reach CR after 2 cycles of induction chemotherapy regimen OR (4)Patients with Ph+ ALL are eligible if they are intolerant to or have failed two lines of TKI therapy, or if TKI therapy is contraindicated
- CD19 tumor expression demonstrated in bone marrow or peripheral blood by flow cytometry
- Bone marrow with ≥ 5% lymphoblasts by morphologic assessment
- Adequate organ function defined as:(1)left ventricular ejection fraction ≥ 50% by echocardiogram；(2)creatinine ≤ 1.6mg/dl；(3)ALT and AST≤3 times the ULN for age, total bilirubin ≤ 2.0mg/dl；(4)Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygenation > 91% on room air
- Informed consent is signed by the subject
Key exclusion criteria (18 listed)
- Isolated extra-medullary disease relapse
- Combined with other malignant tumors
- Has had treatment with any prior anti-CD19/anti-CD3 therapy, or any other antiCD19 therapy
- Has had immunosuppressants or hormones within 2 weeks before signing informed consent, or plan to use immunosuppressants or hormones after signing informed consent
- 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, anti-treponemia pallidum antibody (TP-Ab) positive, EBV-DNA, and CMV-DNA copies being more than the lower limit of detection
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-19 CellsSplit-Dose of ssCART-19 cells will be infused, and classic "3+3" dose escalation will be applied. | Genetic | ssCART-19 Cells |
| FludarabineAlso: FAFludarabine is used for lymphodepletion. | Drug | ssCART-19 Cells |
| CyclophosphamideAlso: CTXCyclophosphamide is used for lymphodepletion. | Drug | ssCART-19 Cells |
Primary outcome
Dose Limiting Toxicity (DLT)
Time frame: 28 days
Determine the safety and tolerability of ssCART-19 in patients with refractory or relapsed acute lymphoblastic leukemia. Safety measures include adverse events as assessed by CTCAE v5.0.
4 secondary outcomes
Overall Remission Rate (ORR), which includes Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi)
Time frame: 3 months
Duration of remission (DOR)
Time frame: 24 months
Progression-free Survival (PFS)
Time frame: 24 months
Overall survival (OS)
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
Related trials for Relapsed or Refractory Acute Lymphoblastic Leukemia
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
RecruitingPhase 1
In VIVO CAR-T Therapy for Relapsed/Refractory Hematological Malignancies
B-Acute Lymphoblastic Leukemia, B Cell Non-Hodgkin's Lymphoma
Active, not recruitingPhase 2
Study of Blinatumomab Administration in Chinese Pediatric Participants With Relapsed/Refractory B Precursor Acute Lymphoblastic Leukemia (R/R B-ALL)
B Precursor Acute Lymphoblastic Leukemia, Relapsed/Refractory B Precursor Acute Lymphoblastic Leukemia
RecruitingPhase 1
GN001 for Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma and B-Cell Acute Lymphoblastic Leukemia
Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma, Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia
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.
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 ssCART-19 Cells, Fludarabine and Cyclophosphamide in people with Relapsed or Refractory Acute Lymphoblastic Leukemia, run by Shanghai Unicar-Therapy Bio-medicine Technology Co.,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 11 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: status not confirmed, as of the sponsor's last update on 21 Sep 2023. 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 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?
Dose Limiting Toxicity (DLT) (time frame: 28 days). 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 21 Sep 2023.