Hematological MalignanciesPhase 1NCT03344705
Safety and Efficacy Evaluation of IM19 Cells
A Phase 1 study testing IM19 CAR-T, Fludarabine and Cyclophosphamide in people with Hematological Malignancies, run by Beijing Immunochina Medical Science & Technology Co., Ltd. at 1 site in China.
Trial summary
Assessment of the Safety and Feasibility of Administering T cells Expressing an Anti-CD19 Chimeric Antigen Receptor to Patients With CD19+ B-cell Hematological Malignancies. Read more about this study
- Who is it for?
- Ages 4 to 75 years
- Conditions the study is for
- Hematological Malignancies
- What is being tested?
- IM19 CAR-T, Fludarabine and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 21 Aug 2017to 1 Dec 2020
- 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 4 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with CD19 positive relapsed or refractory B-cell malignancies, including B-cell Acute Lymphocytic Leukemia(ALL)、B-cell Chronic Lymphocytic Leukemia(CLL)、Non-Hodgkin's lymphoma(NHL).
- 1)Patients with ALL:
- Previously treated with at least two courses of chemotherapy Ⅱ The interval of the last chemotherapy and disease progression is less than one year.
- Ⅲ Not suitable for allogeneic stem cell transplantation. 2)Patients with CLL:
- Previously treated with at least two courses of chemotherapy
- Ⅱ The interval of the last chemotherapy and disease progression is less than two years.
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- Ⅲ Not suitable for allogeneic stem cell transplantation conditions or due to conditions to abandon allogeneic stem cell transplantation.
- 3) Patients with DLBCL or FL、PMBCL:
- Patients who relapsed or were refractory after at least two previous treatments.
- Ⅱ Patients who relapsed after transplantation. 4)Patients who have relapsed or have refractory mantle cell lymphoma after at least one treatment.
- 2.Measurable disease,including minimal residual disease. 3.Gender is not limited, to be aged 4 to 75 years 4.Expected survival >3 months. 5.Eastern Cooperative Oncology Group(ECOG) score 0-2. 6.Women of childbearing potential must have a blood pregnancy test taken and proven negative prior to the treatment. All patients agree to use reliable methods of contraception during the trial period and until follow-up for the last time.
- 7.Absence of symptoms of central nervous system(CNS) leukemia.
Who cannot join
- Patients who have been treated with chemotherapy or radiotherapy within 2 weeks before blood collection.
- Patients have GVHD, which needs treatment with immunosuppressive agents,or patients with autoimmune diseases.
- Patient who have been treated with systemic steroid medication within two weeks of blood collection（Except for the recent or current use of inhaled steroids）.
- Patient who have been treated with stimulation of bone marrow hematopoietic cells generated drugs(Such as Recombinant Human Granulocyte Colony-stimulating Factor Injection) within 2 weeks before the blood collection period to use .
- The number of T cells in peripheral blood is lower than 2×10^8/L.
- Previously treatment with any gene therapy products.
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- History of epilepsy or other CNS disease.
- New York Heart Association(NYHA) grade≥Ⅲ.
- Creatinine> 1.5×normal value，Alanine transaminase(ALT) /Aspartate aminotransferase(AST)>3×normal value，Bilirubin >2×normal value.
- Degree of myeloproliferation： Ⅳ-V
- Active hepatitis B , hepatitis C or HIV infection and cytomegalovirus infection ,Epstein-Barr virus infection or any other uncontrolled active infection.
- Pregnancy or breast-feeding women.
- Any uncontrolled medical disorders that the researchers considered are not suitable to participate the clinical trial.
- Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality
Xinan Lu, Dr, 86-189-1157-6946, luxian@immunochina.com
About this study
Official title: Safety and Efficacy Evaluation of IM19 Chimeric Antigen Receptor-modified T Cells (IM19CAR-T) In CD19+ B Cell Malignancies
Assessment of the Safety and Feasibility of Administering T cells Expressing an Anti-CD19 Chimeric Antigen Receptor to Patients With CD19+ B-cell Hematological Malignancies.
Read the detailed description
Assessment of the Safety and Feasibility of Administering T cells Expressing an Anti-CD19 Chimeric Antigen Receptor to Patients With CD19+ B-cell Hematological Malignancies(including B-cell Acute lymphoblastic Leukemia、B-cell Chronic Lymphocytic Leukemia、Non-Hodgkin's lymphoma) and Determine the Best Dosage.
- Conditions
- Hematological Malignancies
- Being tested
- IM19 CAR-T, Fludarabine, Cyclophosphamide
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IM19 CAR-TBiological
Also called IM19
All patients will be treated with fludarabine and cyclophosphamide for 3 days. Two days later, Cells Expressing an Anti-CD19 Chimeric Antigen Receptor will be infused.
FludarabineDrug
Also called F
Two days before cell infusion,all patients will be treated with fludarabine for 3 days
CyclophosphamideDrug
Also called C
Two days before cell infusion,all patients will be treated with cyclophosphamide for 3 days
| Study group | Role | What they receive |
|---|---|---|
| IM19 CART | Experimental | All patients will be treated with fludarabine and cyclophosphamide for 3 days,then,CAR-T cells expressing CD19 CAR will be infused 24-96 hours later. Receives: Biological: IM19 CAR-T; Drug: Fludarabine; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of study related adverse events
defined as >= Grade 3 signs/symptoms,laboratory toxicities,and clinical events that are possibly,likely,or definitely related to study treatment Adverse events assessed according to NCI-CTCAE v4.0 criteria 2.
Measured: 2 years
Secondary outcomes (1)
Overall response rate
- Overall response rate An objective response is defined as: (1) a morphologic complete response (CR) or (2) a complete response with incomplete recovery of counts (CRi) (based on NCCN guidelines (National Comprehensive Cancer Network (NCCN), 2014) or (3) a negative minimal residual disease assessed by flow cytometry
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 posted17 Nov 2017
- Study start21 Aug 2017
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hematological MalignanciesStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Immunochina Medical Science & Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hongmei Jing, MD, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03344705
- Sponsor's protocol ID
- YMCART201701
- Status last verified
- Nov 2017
- First submitted
- 14 Nov 2017
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bao F, Wan W, He T, Qi F, Liu G, Hu K, Lu XA, Yang P, Dong F, Wang J, Jing H. Autologous CD19-directed chimeric antigen receptor-T cell is an effective and safe treatment to refractory or relapsed diffuse large B-cell lymphoma. Cancer Gene Ther. 2019 Jul;26(7-8):248-255. doi: 10.1038/s41417-018-0073-7. Epub 2019 Jan 9.
PubMed 30622321
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Evaluation of IM19 Chimeric Antigen Receptor-modified T Cells (IM19CAR-T) In CD19+ B Cell Malignancies
- ClinicalTrials.gov ID
- NCT03344705
- Acronym / sponsor ID
- YMCART201701
- Conditions
- Hematological Malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Beijing Immunochina Medical Science & Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Aug 2017 (actual)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 17 Nov 2017 (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.
Assessment of the Safety and Feasibility of Administering T cells Expressing an Anti-CD19 Chimeric Antigen Receptor to Patients With CD19+ B-cell Hematological Malignancies.
Detailed description
Assessment of the Safety and Feasibility of Administering T cells Expressing an Anti-CD19 Chimeric Antigen Receptor to Patients With CD19+ B-cell Hematological Malignancies(including B-cell Acute lymphoblastic Leukemia、B-cell Chronic Lymphocytic Leukemia、Non-Hodgkin's lymphoma) and Determine the Best Dosage.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IM19 CART | Experimental | Biological: IM19 CAR-T, Drug: Fludarabine, Drug: CyclophosphamideAll patients will be treated with fludarabine and cyclophosphamide for 3 days,then,CAR-T cells expressing CD19 CAR will be infused 24-96 hours later. |
Who may qualify
- Ages
- 4 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Patients with CD19 positive relapsed or refractory B-cell malignancies, including B-cell Acute Lymphocytic Leukemia(ALL)、B-cell Chronic Lymphocytic Leukemia(CLL)、Non-Hodgkin's lymphoma(NHL).
- Previously treated with at least two courses of chemotherapy Ⅱ The interval of the last chemotherapy and disease progression is less than one year.
- Previously treated with at least two courses of chemotherapy
- Ⅱ The interval of the last chemotherapy and disease progression is less than two years.
- Ⅲ Not suitable for allogeneic stem cell transplantation conditions or due to conditions to abandon allogeneic stem cell transplantation.
Key exclusion criteria (14 listed)
- Patients who have been treated with chemotherapy or radiotherapy within 2 weeks before blood collection.
- Patients have GVHD, which needs treatment with immunosuppressive agents,or patients with autoimmune diseases.
- Patient who have been treated with systemic steroid medication within two weeks of blood collection（Except for the recent or current use of inhaled steroids）.
- Patient who have been treated with stimulation of bone marrow hematopoietic cells generated drugs(Such as Recombinant Human Granulocyte Colony-stimulating Factor Injection) within 2 weeks before the blood collection period to use .
- The number of T cells in peripheral blood is lower than 2×10^8/L.
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 |
|---|---|---|
| IM19 CAR-TAlso: IM19All patients will be treated with fludarabine and cyclophosphamide for 3 days. Two days later, Cells Expressing an Anti-CD19 Chimeric Antigen Receptor will be infused. | Biological | IM19 CART |
| FludarabineAlso: FTwo days before cell infusion,all patients will be treated with fludarabine for 3 days | Drug | IM19 CART |
| CyclophosphamideAlso: CTwo days before cell infusion,all patients will be treated with cyclophosphamide for 3 days | Drug | IM19 CART |
Primary outcome
Occurrence of study related adverse events
Time frame: 2 years
defined as >= Grade 3 signs/symptoms,laboratory toxicities,and clinical events that are possibly,likely,or definitely related to study treatment Adverse events assessed according to NCI-CTCAE v4.0 criteria 2.
1 secondary outcome
Overall response rate
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 17 Nov 2017.
- Derived from this study: PubMed 30622321Bao F, Wan W, He T, Qi F, Liu G, Hu K, Lu XA, Yang P, Dong F, Wang J, Jing H. Autologous CD19-directed chimeric antigen receptor-T cell is an effective and safe treatment to refractory or relapsed diffuse large B-cell lymphoma. Cancer Gene Ther. 2019 Jul;26(7-8):248-255. doi: 10.1038/s41417-018-0073-7. Epub 2019 Jan 9.
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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.
Hongmei Jing, MD principal investigator
Peking University Third Hospital
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 IM19 CAR-T, Fludarabine and Cyclophosphamide in people with Hematological Malignancies, run by Beijing Immunochina Medical Science & 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 12 inclusion and 14 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 17 Nov 2017. 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 Xin-an Lu, Dr (86-189-1157-6946, luxinan@immunochina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of study related adverse events (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03344705, which also lists 1 linked publication.
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 17 Nov 2017.