LeukemiaPhase 1/2NCT03173417
Safety and Efficacy Evaluation of IM19 CAR-T Cells (IM19CAR-T)
A Phase 1/2 study testing IM19 CAR-T and fludarabine and cyclophosphamide in people with Leukemia, 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 leukemia. Read more about this study
- Who is it for?
- Ages 3 to 75 years
- Conditions the study is for
- Leukemia
- What is being tested?
- IM19 CAR-T and fludarabine and cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 1 siteChina
- Study dates
- 23 May 2017to 1 May 2019
- 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 3 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with CD19+ Refractory or Relapsed B-ALL（At least 2 prior combination chemotherapy regimens）
- To be aged 3 to 75 years
- Blast in blood ≤ 30%
- ECOG score ≤2
- Women of childbearing potential must have a urine 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.
- Voluntary participation in the clinical trials and sign the informed consent.
Who cannot join
- Intracranial hypertension or unconsciousness
- Respiratory failure
- CD19 negative
- Disseminated intravascular coagulation
- ALT /AST>3 x normal value; Creatinine> 1.5 x normal value; Bilirubin >2.0 x normal value
- Hematosepsis or Uncontrolled active infection
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- Uncontrolled diabetes
- Abalienation;
- WHO Sscore >3
- Patients in pregnancy or breast-feeding period
- Previously treatment with any gene therapy products
- Any uncontrolled medical disorders that the researchers consider are not eligible 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.
About this study
Official title: Safety and Efficacy Evaluation of IM19 CAR-T Cells On CD19+ Refractory or Relapsed B-ALL Patients
Assessment of the Safety and Feasibility of Administering T Cells Expressing an Anti-CD19 Chimeric Antigen Receptor to Patients With CD19+ B-cell leukemia.
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 leukemia and determine the best dosage.
- Conditions
- Leukemia
- Being tested
- IM19 CAR-T, fludarabine and cyclophosphamide
- Medical subject headings
- Leukemia
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
T Cells Expressing an Anti-CD19 Chimeric Antigen Receptor
fludarabine and cyclophosphamideDrug
Also called FC
Two days before cell infusion,all patients will be treated with fludarabine and 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 and 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
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 posted1 Jun 2017
- Study start23 May 2017
- Primary completion1 May 2019
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Immunochina Medical Science & Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- PEIHUA LU, MD, Principal investigator, Hebei Yanda Ludaopei Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03173417
- Sponsor's protocol ID
- YMCART201702
- Status last verified
- May 2019
- First submitted
- 30 May 2017
- Last updated
- 20 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chen M, Fu M, Wang A, Wu X, Zhen J, Gong M, Zhang X, Yue G, Du Q, Zhao W, Zhao Y, Lu P, Wang H. Cytoplasmic CD79a is a promising biomarker for B lymphoblastic leukemia follow up post CD19 CAR-T therapy. Leuk Lymphoma. 2022 Feb;63(2):426-434. doi: 10.1080/10428194.2021.1980214. Epub 2021 Oct 21.
PubMed 34672246Zhang X, Lu XA, Yang J, Zhang G, Li J, Song L, Su Y, Shi Y, Zhang M, He J, Song D, Lv F, Li W, Wu Y, Wang H, Liu H, Zhou X, He T, Lu P. Efficacy and safety of anti-CD19 CAR T-cell therapy in 110 patients with B-cell acute lymphoblastic leukemia with high-risk features. Blood Adv. 2020 May 26;4(10):2325-2338. doi: 10.1182/bloodadvances.2020001466.
PubMed 32453841
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Evaluation of IM19 CAR-T Cells On CD19+ Refractory or Relapsed B-ALL Patients
- ClinicalTrials.gov ID
- NCT03173417
- Acronym / sponsor ID
- YMCART201702
- Conditions
- Leukemia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Beijing Immunochina Medical Science & Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 May 2017 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 1 Jun 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 leukemia.
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 leukemia 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 and 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
- 3 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with CD19+ Refractory or Relapsed B-ALL（At least 2 prior combination chemotherapy regimens）
- To be aged 3 to 75 years
- Blast in blood ≤ 30%
- ECOG score ≤2
- Women of childbearing potential must have a urine 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.
Key exclusion criteria (13 listed)
- Intracranial hypertension or unconsciousness
- Respiratory failure
- CD19 negative
- Disseminated intravascular coagulation
- ALT /AST>3 x normal value; Creatinine> 1.5 x normal value; Bilirubin >2.0 x normal value
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: IM19T Cells Expressing an Anti-CD19 Chimeric Antigen Receptor | Biological | IM19 CART |
| fludarabine and cyclophosphamideAlso: FCTwo days before cell infusion,all patients will be treated with fludarabine and 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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2019.
- Derived from this study: PubMed 34672246Chen M, Fu M, Wang A, Wu X, Zhen J, Gong M, Zhang X, Yue G, Du Q, Zhao W, Zhao Y, Lu P, Wang H. Cytoplasmic CD79a is a promising biomarker for B lymphoblastic leukemia follow up post CD19 CAR-T therapy. Leuk Lymphoma. 2022 Feb;63(2):426-434. doi: 10.1080/10428194.2021.1980214. Epub 2021 Oct 21.
- Derived from this study: PubMed 32453841Zhang X, Lu XA, Yang J, Zhang G, Li J, Song L, Su Y, Shi Y, Zhang M, He J, Song D, Lv F, Li W, Wu Y, Wang H, Liu H, Zhou X, He T, Lu P. Efficacy and safety of anti-CD19 CAR T-cell therapy in 110 patients with B-cell acute lymphoblastic leukemia with high-risk features. Blood Adv. 2020 May 26;4(10):2325-2338. doi: 10.1182/bloodadvances.2020001466.
- Individual participant dataSharing planned: Undecided
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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.
PEIHUA LU, MD principal investigator
Hebei Yanda Ludaopei Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IM19 CAR-T and fludarabine and cyclophosphamide in people with Leukemia, 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 6 inclusion and 13 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: finished, as of the sponsor's last update on 20 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 NCT03173417, which also lists 2 linked publications.
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 20 May 2019.