Acute Lymphoblastic Leukemia ,LymphomasPhase 1/2NCT04196205
Anti-CD19 CAR-T Cells for Relapsed or Refractory Acute Lymphoblastic Leukemia and Lymphomas
A Phase 1/2 study testing Anti-CD19 CAR-T in people with Acute Lymphoblastic Leukemia ,Lymphomas, run by The First Affiliated Hospital of Nanchang University at 1 site in China.
Trial summary
This is a single arm, open-label, single center study to determine the safety and efficacy of Anti-CD19 CAR-T cells in patients with relapsed or refractory acute lymphoblastic leukemia and Lymphomas. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia ,Lymphomas
- What is being tested?
- Anti-CD19 CAR-T
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2019to 1 Aug 2021
- Phase
- Phase 1/2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- The patient is a pregnant or breastfeeding woman, or is a woman with a pregnancy plan within six months;
- Patients have infectious diseases (such as HIV, active tuberculosis, etc.);
- The patient is an active hepatitis B or hepatitis C infection;
- Feasibility assessment proves that the efficiency of transduction of lymphocyte is below 10% or the lymphocyte cannot be propagated ;
- Abnormal vital signs;
- Subjects with mental or psychological illness who cannot be combined with treatment and efficacy evaluation;
Show all 11Show fewer
- Highly allergic constitution or history of severe allergies, especially allergy to interleukin-2;
- General infection or local severe infection, or other infection that is not controlled;
- Dysfunction in lung, heart, kidney and brain;
- Severe autoimmune diseases;
- Other symptoms that are not applicable for CAR-T.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Nangchang University
Nanchang, Jiangxi, 330006
Fei Li, M.D., Ph.D., +86-139-7003-8386, yx021021@sina.com
About this study
Official title: Study Evaluating the Safety and Efficacy With Anti-CD19 CAR-T Cells for Relapsed or Refractory Acute Lymphoblastic Leukemia and Lymphomas
This is a single arm, open-label, single center study to determine the safety and efficacy of Anti-CD19 CAR-T cells in patients with relapsed or refractory acute lymphoblastic leukemia and Lymphomas.
Read the detailed description
CD19 has been extensively evaluated as a therapeutic target for relapsed or refractory B cell malignancy by chimeric antigen receptor T cell therapy,this is a single arm, open-label, single center study to determine the safety and efficacy of Anti-CD19 CAR-T cells in patients with refractory acute lymphoblastic leukemia and Lymphomas.
- Conditions
- Acute Lymphoblastic Leukemia ,Lymphomas
- Being tested
- Anti-CD19 CAR-T
- Keywords
- acute lymphoblastic leukemia ;Lymphomas
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-CD19 CAR-TBiological
1 - 2×10^6 Anti-CD19 CAR-T cells/kg body weigh
| Study group | Role | What they receive |
|---|---|---|
| Anti-CD19 CAR-T | Experimental | Anti-CD19 CAR-T Receives: Biological: Anti-CD19 CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall responce rate(ORR)
Assessment of ORR (ORR = CR+PR ) at 2 months of treatment
Measured: 2 years
Overall survival (OS)
Assessment of OS(Overall survival) at 6 months of treatment
Measured: 2 years
Progression-free survival (PFS)
Assessment of PFS(Progression-free survival ) at 6 months of treatment
Measured: 2 years
minimal residual disease（MRD）
Assessment of MRD negative overall response rate at 3 months of treatment
Measured: 2 years
Secondary outcomes (3)
Safety (incidence of adverse events defined as dose-limited toxicity)
Occurrence of study related adverse events defined as NCI CTCAE 4.0 > grade 3 possibly, probably, or definitely related to study treatment.
Measured: Study treatment until Week 24
Expression of CD19 CART cells
Expression of CD19 CART cells detected by flow cytometry in blood and bone marrow.
Measured: 2 years
Detection of CD19 CART cells
Detection of CD19 CART cells in blood, bone marrow by Quantitative Polymerase Chain Reaction (q-PCR).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start1 Dec 2019 (estimated)
- Primary completion1 Aug 2020 (estimated)
- Study completion1 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic Leukemia ,LymphomasStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Nanchang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LiFei, The First Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04196205
- Sponsor's protocol ID
- 2018027
- Status last verified
- Dec 2019
- First submitted
- 9 Dec 2019
- Last updated
- 12 Dec 2019
- 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 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Evaluating the Safety and Efficacy With Anti-CD19 CAR-T Cells for Relapsed or Refractory Acute Lymphoblastic Leukemia and Lymphomas
- ClinicalTrials.gov ID
- NCT04196205
- Acronym / sponsor ID
- 2018027
- Conditions
- Acute Lymphoblastic Leukemia ,Lymphomas
- Keywords
- acute lymphoblastic leukemia ;Lymphomas
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Nanchang UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (estimated)
- Primary completion
- 1 Aug 2020 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 12 Dec 2019 (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, single center study to determine the safety and efficacy of Anti-CD19 CAR-T cells in patients with relapsed or refractory acute lymphoblastic leukemia and Lymphomas.
Detailed description
CD19 has been extensively evaluated as a therapeutic target for relapsed or refractory B cell malignancy by chimeric antigen receptor T cell therapy,this is a single arm, open-label, single center study to determine the safety and efficacy of Anti-CD19 CAR-T cells in patients with refractory acute lymphoblastic leukemia and Lymphomas.
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 CAR-T | Experimental | Biological: Anti-CD19 CAR-TAnti-CD19 CAR-T |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (11 listed)
- The patient is a pregnant or breastfeeding woman, or is a woman with a pregnancy plan within six months;
- Patients have infectious diseases (such as HIV, active tuberculosis, etc.);
- The patient is an active hepatitis B or hepatitis C infection;
- Feasibility assessment proves that the efficiency of transduction of lymphocyte is below 10% or the lymphocyte cannot be propagated ;
- Abnormal vital signs;
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 CAR-T1 - 2×10^6 Anti-CD19 CAR-T cells/kg body weigh | Biological | Anti-CD19 CAR-T |
Primary outcome
Overall responce rate(ORR)
Time frame: 2 years
Assessment of ORR (ORR = CR+PR ) at 2 months of treatment
Overall survival (OS)
Time frame: 2 years
Assessment of OS(Overall survival) at 6 months of treatment
Progression-free survival (PFS)
Time frame: 2 years
Assessment of PFS(Progression-free survival ) at 6 months of treatment
minimal residual disease（MRD）
Time frame: 2 years
Assessment of MRD negative overall response rate at 3 months of treatment
3 secondary outcomes
Safety (incidence of adverse events defined as dose-limited toxicity)
Time frame: Study treatment until Week 24
Expression of CD19 CART cells
Time frame: 2 years
Detection of CD19 CART cells
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
Related trials for Acute Lymphoblastic Leukemia ,Lymphomas
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Not yet recruitingPhase 2
Obesity Treatment With Phentermine-Topiramate ER in AYA Surviving Leukemia and Lymphoma
Acute Lymphoblastic Leukemia in Remission, Hodgkin Lymphoma in Remission
Recruiting
A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymph...
B-All, 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
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 1/2 study testing Anti-CD19 CAR-T in people with Acute Lymphoblastic Leukemia ,Lymphomas, run by The First Affiliated Hospital of Nanchang University 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 0 inclusion and 11 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 12 Dec 2019. 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 combined 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.
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 Fei Li, M.D., Ph.D. (+86-139-7003-8386, yx021021@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall responce rate(ORR) (time frame: 2 years). The study lists 4 primary outcomes in all. 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 12 Dec 2019.