B-cell Acute Lymphoblastic LeukemiaEarly Phase 1NCT04264039
Anti-CD19 U-CAR-T Cell Therapy for B Cell Hematologic Malignancies
A Early Phase 1 study testing anti-CD19 UCAR-T cells, Fludarabine and Cytoxan in people with B-cell Acute Lymphoblastic Leukemia and B-cell Lymphoma, run by Xinqiao Hospital of Chongqing at 1 site in China.
Trial summary
The stunning response rate of anti-CD19(cluster of differentiation antigen 19) auto-CAR(chimeric antigen receptor)-T cell therapy brings hope to patients with relapsed or refractory B-cell hematologic malignancies. Read more about this study
- Who is it for?
- Ages 2 to 70 years
- Conditions the study is for
- B-cell Acute Lymphoblastic Leukemia, B-cell Lymphoma
- What is being tested?
- anti-CD19 UCAR-T cells, Fludarabine and Cytoxan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2020to 1 Apr 2022
- Phase
- Early 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 2 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1. Diagnosis of recurrent B-cell acute lymphoblastic leukemia (B-ALL), B-cell acute lymphoblastic lymphoma (B-LLy), or B-non-Hodgkin lymphoma (B-NHL)
- 2. CD19-positive tumor (≥20% CD19 positive blasts by flow cytometry or immunohistochemistry (tissue)）
- 3. Hgb ≥ 7.0 (can be transfused)
- 4. Life expectancy greater than 12 weeks
- 5. Informed consent explained to, understood by and signed by the patient/guardian. The patient/guardian is given a copy of informed consent.
Who cannot join
- Pregnant or lactating.
- Tumor in a location where enlargement could cause airway obstruction (per investigator discretion).
- Active infection with HIV or HTLV.
- Clinically significant viral infection or uncontrolled viral reactivation of EBV(Epstein-Barr virus), CMV(cytomegalovirus), ADV(adenovirus), BK-virus, or HHV(human herpesvirus)-6.
- Any of the following cardiac criteria: Atrial fibrillation/flutter; Myocardial infarction within the last 12 months; Prolonged QT syndrome or secondary prolonged QT, per investigator discretion. Cardiac echocardiography with LVSF (left ventricular shortening fraction)<30% or LVEF(left ventricular ejection fraction)<50%; or clinically significant pericardial effusion. Cardiac dysfunction NYHA(New York Heart Association) III or IV (Confirmation of absence of these conditions on echocardiogram within 12 months of treatment).
- CNS abnormalities: Presence of CNS(central nervous system)-3 disease defined as detectable cerebrospinal blast cells in a sample of CSF(cerebrospinal fluid) with ≥ 5 WBC( white blood cell)s per mm3 (unless negative by the Steinherz/Bleyer algorithm); Presence of any CNS disorder such as an uncontrolled seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Hematology, Xinqiao Hospital
Chongqing, Chongqing Municipality, 400037
About this study
Official title: Anti-CD19 Universal CAR-T Cells for CD19+ B Cell Hematologic Malignancies: a Multi-center, Uncontrolled Trial
The stunning response rate of anti-CD19(cluster of differentiation antigen 19) auto-CAR(chimeric antigen receptor)-T cell therapy brings hope to patients with relapsed or refractory B-cell hematologic malignancies. However, based on open clinical trials, using patients' T cells might encounter the failure of apheresis available T cells, even if successful, the time needed for the manufacture could also cause the irreversible disease progress. Furthermore, the cost of auto-CAR-T cells is not affordable for most patients. So to provide an accessible and affordable anti-CD19 CAR-T cell therapy for patients with B-cell hematologic malignancies, we launch such a trial that using the edited T cells from healthy donors to manufacture universal CAR-T cells and adapt it in patients with CD19+ B-cell leukemia or lymphoma.
- Being tested
- anti-CD19 UCAR-T cells, Fludarabine, Cytoxan, Melphalan
- Medical subject headings
- Burkitt Lymphoma, Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-CD19 UCAR-T cellsBiological
Dose range:1 to 5 ×10^7 cells/Kg, Dose level one: 1×10^7 cells/Kg, Dose level two: 3×10^7 cells/Kg, Dose level three:5 ×10^7 cells/Kg
FludarabineDrug
30mg/m^2 per day for 6 days
CytoxanDrug
300mg/m^2 per day for 2 to 6 days determined by tumor burden at baseline
MelphalanDrug
50 to 70 mg/m^2 in total for 1 or 2 days, whether to use determined by tumor burden at baseline
| Study group | Role | What they receive |
|---|---|---|
| anti-CD19 UCAR-T cells | Experimental | After preconditioning with chemotherapy ( Fludarabine, Cytoxan and/or Melphalan), the dosage of anti-CD19 UCAR-T cells between 1 and 5 ×10^7 cells/Kg will be evaluated Receives: Biological: anti-CD19 UCAR-T cells; Drug: Fludarabine; Drug: Cytoxan; Drug: Melphalan |
What is being measured
The primary outcome is the main question the study is designed to answer.
the anti-tumor efficiency of anti-CD19 UCAR-T cells
ratio of bone marrow blast cells and/or the measurable lesion size and strandralized uptake value
Measured: 4 weeks after infusion
Secondary outcomes (1)
the long-term efficiency of anti-CD19 UCAR-T cells
ratio of bone marrow blast cells and/or the measurable lesion size and strandralized uptake value
Measured: 3 and 6 months after infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start1 Apr 2020 (estimated)
- Primary completion1 Apr 2021 (estimated)
- Study completion1 Apr 2022 (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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xinqiao Hospital of Chongqing
- Sponsor type
- University, hospital or other
- Collaborators
- Gracell Biotechnologies (Shanghai) Co., Ltd., 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China, The Second Affiliated Hospital of Chongqing Medical University, The Affiliated Hospital Of Guizhou Medical University, Central South University, First Affiliated Hospital of Kunming Medical University, The General Hospital of Western Theater Command, Second Affiliated Hospital of Xi'an Jiaotong University, Nanfang Hospital, Southern Medical University, Fujian Medical University Union Hospital, The First Affiliated Hospital of Anhui Medical University, Tang-Du Hospital
- Responsible party
- Principal investigator, Xi Zhang, MD, Xinqiao Hospital of Chongqing
- Investigators
- Xi Zhang, MD, Principal investigator, Xinqiao Hospital of Chongqing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04264039
- Sponsor's protocol ID
- antiCD19-UCAR-T
- Status last verified
- Feb 2020
- First submitted
- 7 Feb 2020
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-CD19 Universal CAR-T Cells for CD19+ B Cell Hematologic Malignancies: a Multi-center, Uncontrolled Trial
- ClinicalTrials.gov ID
- NCT04264039
- Acronym / sponsor ID
- antiCD19-UCAR-T
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Xinqiao Hospital of ChongqingUniversity, hospital or other
- Collaborators
- Gracell Biotechnologies (Shanghai) Co., Ltd., 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China, The Second Affiliated Hospital of Chongqing Medical University, The Affiliated Hospital Of Guizhou Medical University, Central South University, First Affiliated Hospital of Kunming Medical University, The General Hospital of Western Theater Command, Second Affiliated Hospital of Xi'an Jiaotong University, Nanfang Hospital, Southern Medical University, Fujian Medical University Union Hospital, The First Affiliated Hospital of Anhui Medical University, Tang-Du Hospital
- Study start
- 1 Apr 2020 (estimated)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 11 Feb 2020 (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.
The stunning response rate of anti-CD19(cluster of differentiation antigen 19) auto-CAR(chimeric antigen receptor)-T cell therapy brings hope to patients with relapsed or refractory B-cell hematologic malignancies. However, based on open clinical trials, using patients' T cells might encounter the failure of apheresis available T cells, even if successful, the time needed for the manufacture could also cause the irreversible disease progress. Furthermore, the cost of auto-CAR-T cells is not affordable for most patients. So to provide an accessible and affordable anti-CD19 CAR-T cell therapy for patients with B-cell hematologic malignancies, we launch such a trial that using the edited T cells from healthy donors to manufacture universal CAR-T cells and adapt it in patients with CD19+ B-cell leukemia or lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| anti-CD19 UCAR-T cells | Experimental | Biological: anti-CD19 UCAR-T cells, Drug: Fludarabine, Drug: Cytoxan, Drug: MelphalanAfter preconditioning with chemotherapy ( Fludarabine, Cytoxan and/or Melphalan), the dosage of anti-CD19 UCAR-T cells between 1 and 5 ×10^7 cells/Kg will be evaluated |
Who may qualify
- Ages
- 2 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 1. Diagnosis of recurrent B-cell acute lymphoblastic leukemia (B-ALL), B-cell acute lymphoblastic lymphoma (B-LLy), or B-non-Hodgkin lymphoma (B-NHL)
- 2. CD19-positive tumor (≥20% CD19 positive blasts by flow cytometry or immunohistochemistry (tissue)）
- 3. Hgb ≥ 7.0 (can be transfused)
- 4. Life expectancy greater than 12 weeks
- 5. Informed consent explained to, understood by and signed by the patient/guardian. The patient/guardian is given a copy of informed consent.
Key exclusion criteria (6 listed)
- Pregnant or lactating.
- Tumor in a location where enlargement could cause airway obstruction (per investigator discretion).
- Active infection with HIV or HTLV.
- Clinically significant viral infection or uncontrolled viral reactivation of EBV(Epstein-Barr virus), CMV(cytomegalovirus), ADV(adenovirus), BK-virus, or HHV(human herpesvirus)-6.
- Any of the following cardiac criteria: Atrial fibrillation/flutter; Myocardial infarction within the last 12 months; Prolonged QT syndrome or secondary prolonged QT, per investigator discretion. Cardiac echocardiography with LVSF (left ventricular shortening fraction)<30% or LVEF(left ventricular ejection fraction)<50%; or clinically significant pericardial effusion. Cardiac dysfunction NYHA(New York Heart Association) III or IV (Confirmation of absence of these conditions on echocardiogram within 12 months of treatment).
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 |
|---|---|---|
| anti-CD19 UCAR-T cellsDose range:1 to 5 ×10^7 cells/Kg, Dose level one: 1×10^7 cells/Kg, Dose level two: 3×10^7 cells/Kg, Dose level three:5 ×10^7 cells/Kg | Biological | anti-CD19 UCAR-T cells |
| Fludarabine30mg/m^2 per day for 6 days | Drug | anti-CD19 UCAR-T cells |
| Cytoxan300mg/m^2 per day for 2 to 6 days determined by tumor burden at baseline | Drug | anti-CD19 UCAR-T cells |
| Melphalan50 to 70 mg/m^2 in total for 1 or 2 days, whether to use determined by tumor burden at baseline | Drug | anti-CD19 UCAR-T cells |
Primary outcome
the anti-tumor efficiency of anti-CD19 UCAR-T cells
Time frame: 4 weeks after infusion
ratio of bone marrow blast cells and/or the measurable lesion size and strandralized uptake value
1 secondary outcome
the long-term efficiency of anti-CD19 UCAR-T cells
Time frame: 3 and 6 months after infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
Related trials for B-cell Acute Lymphoblastic Leukemia
RecruitingPhase 2/3
A Clinical Trial of MK-1045 in People With B-cell Acute Lymphoblastic Leukemia (MK-1045-005)
B-cell Acute Lymphoblastic Leukemia
Not yet recruitingPhase 1
4SCAR19U T Cells Targeting B Cell Malignancies
B Cell Malignancies
RecruitingPhase 1/2
A Clinical Study of MK-1045 (CN201) in People With Precursor B-cell Acute Lymphoblastic Leukemia (MK-1045-002)
Acute Lymphoblastic Leukemia
RecruitingPhase 1/2
Substudy 01A: Zilovertamab Vedotin in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors (MK-9999-01A/LIGHTBEAM-U01)
B-cell Acute Lymphoblastic Leukemia, Diffuse Large B-cell Lymphoma
RecruitingPhase 1
Anti-CRLF2-R/TSLPR Chimeric Antigen Receptor T Cells (TSLPR-CART) in Participants With Recurrent or Refractory CRLF2-R/TSLPR-Overexpressing B-Cell Acute Lymphoblastic Leukemia (B-ALL)
B-All, 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.
Xi Zhang, MD principal investigator
Xinqiao Hospital of Chongqing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing anti-CD19 UCAR-T cells, Fludarabine and Cytoxan in people with B-cell Acute Lymphoblastic Leukemia and B-cell Lymphoma, run by Xinqiao Hospital of Chongqing 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 5 inclusion and 6 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 11 Feb 2020. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Xi Zhang, MD (+8613808310064 ext. +8613808310064, zhangxxi@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the anti-tumor efficiency of anti-CD19 UCAR-T cells (time frame: 4 weeks 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 11 Feb 2020.