Non Hodgkin LymphomaPhase 1NCT03528421
Assessment of Safety and Efficacy of IM19 for Relapsed or Refractory NHL Patients
A Phase 1 study testing IM19, Fludarabine and Cyclophosphamide in people with Non Hodgkin Lymphoma, run by Beijing Immunochina Medical Science & Technology Co., Ltd. at 1 site in China.
Trial summary
n this study, approximately 30 patients with relapsed or refractory non-Hodgkin's lymphoma (NHL) were recruited for a single reinfusion of IM19-CD28 and IM19-41BB CAR-T cells. Assess the safety, tolerability of treatment, and initially observe the efficacy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Hodgkin Lymphoma
- What is being tested?
- IM19, Fludarabine and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 22 May 2018to May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Relapsed or refractory CD19-positive non-Hodgkin lymphoma (NHL) patients. 1 Diffuse large B lymphoma (DLBCL), follicular lymphoma (FL), primary mediastinal B-cell lymphoma (PMBCL) patients meet one of the following conditions: I Patients who have relapsed or are refractory after at least 2 previous treatments; II Patients who have relapsed after transplantation. 2 Patients with relapsed or refractory mantle cell lymphoma after at least one treatment.
- Patients must have evaluable disease evidence;
- Age ≥ 18 years old;
- The expected life span is more than 3 months;
- ECOG score 0-2 points (see Attachment 2);
- Women of childbearing age have a negative blood pregnancy test before the start of the trial and agree to have effective contraceptive measures during the trial until the last follow-up;
- Those who voluntarily participate in the trial and sign the informed consent.
Who cannot join
- Patients with high-risk organ involvement: tumors invade one of the central nervous system, gastrointestinal tract, lungs, pericardium, and large vessels;
- Those who have a graft-versus-host response and need to use immunosuppressive drugs; or who have a disease of the autoimmune system;
- Use chemotherapy or radiotherapy within 3 days before the blood collection period;
- Those who have used systemic steroids within the 5 days prior to the blood sampling period (except recently or currently using inhaled steroids);
- Use stimulating bone marrow hematopoietic cells to produce drugs (whitening needles, etc.) within 5 days before the blood collection period;
- Those who have previously used any gene therapy products;
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- History of epilepsy or other diseases of the central nervous system;
- New York Heart Association (NYHA) class III or above (see Annex 3);
- creatinine> 1.5 times the upper limit of normal or ALT / AST> 3 times the upper limit of normal or bilirubin> 2 times the normal upper limit;
- active Hepatitis B or Hepatitis C virus, HIV or other untreated active infections;
- pregnant or lactating women;
- suffer from other uncontrolled diseases that the researcher considers inappropriate;
- Any condition that the investigator believes may increase the subject's risk or interfere with the test results.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality
Xinan Lu, Dr.
Jun Zhu
About this study
Official title: Clinical Study to Evaluate the Safety and Efficacy of IM19 CAR-T Cell Therapy in Patients With Relapsed or Refractory CD19-positive Non-Hodgkin's Lymphoma
n this study, approximately 30 patients with relapsed or refractory non-Hodgkin's lymphoma (NHL) were recruited for a single reinfusion of IM19-CD28 and IM19-41BB CAR-T cells. Assess the safety, tolerability of treatment, and initially observe the efficacy.
Read the detailed description
- Dose-escalation:Patients entered the IM19-41BB or IM19-CD28 group and performed dose escalation studies in three dose groups.
- According to the results of the previous dose escalation study, select one dose to continue the enrollment of 6 patients for extended studies.
- Conditions
- Non Hodgkin Lymphoma
- Being tested
- IM19, Fludarabine, Cyclophosphamide
- Keywords
- CAR-T
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IM19Biological
CAR-T cells
FludarabineDrug
Two days before cell infusion, all patients will be treated with fludarabine for 3 days
CyclophosphamideDrug
Two days before cell infusion, all patients will be treated with Cyclophosphamide for 3 days
| Study group | Role | What they receive |
|---|---|---|
| IM19 CAR-T cells | Experimental | 3*10^5/kg，1*10^6/kg，3*10^6/kg IM19 CAR-T cell.Two days before cell infusion, all patients will be treated with fludarabine and Cyclophosphamide for 3 days Receives: Biological: IM19; 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
>= 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
(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)
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 May 2018
- Study start22 May 2018
- Primary completionApr 2020 (estimated)
- Study completionMay 2020 (estimated)
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 Non Hodgkin LymphomaStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Immunochina Medical Science & Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Peking University Cancer Hospital & Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03528421
- Sponsor's protocol ID
- YMCART201705
- Status last verified
- May 2018
- First submitted
- 7 May 2018
- Last updated
- 16 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.
PubMed 34515338Ying Z, He T, Wang X, Zheng W, Lin N, Tu M, Xie Y, Ping L, Zhang C, Liu W, Deng L, Wu M, Feng F, Leng X, Du T, Qi F, Hu X, Ding Y, Lu XA, Song Y, Zhu J. Distribution of chimeric antigen receptor-modified T cells against CD19 in B-cell malignancies. BMC Cancer. 2021 Feb 25;21(1):198. doi: 10.1186/s12885-021-07934-1.
PubMed 33632155
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Safety and Efficacy of IM19 CAR-T Cell Therapy in Patients With Relapsed or Refractory CD19-positive Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT03528421
- Acronym / sponsor ID
- YMCART201705
- Conditions
- Non Hodgkin Lymphoma
- Keywords
- CAR-T
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Beijing Immunochina Medical Science & Technology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Peking University Cancer Hospital & Institute
- Study start
- 22 May 2018 (actual)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 17 May 2018 (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.
n this study, approximately 30 patients with relapsed or refractory non-Hodgkin's lymphoma (NHL) were recruited for a single reinfusion of IM19-CD28 and IM19-41BB CAR-T cells. Assess the safety, tolerability of treatment, and initially observe the efficacy.
Detailed description
- Dose-escalation:Patients entered the IM19-41BB or IM19-CD28 group and performed dose escalation studies in three dose groups.
- According to the results of the previous dose escalation study, select one dose to continue the enrollment of 6 patients for extended studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IM19 CAR-T cells | Experimental | Biological: IM19, Drug: Fludarabine, Drug: Cyclophosphamide3*10^5/kg，1*10^6/kg，3*10^6/kg IM19 CAR-T cell.Two days before cell infusion, all patients will be treated with fludarabine and Cyclophosphamide for 3 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Relapsed or refractory CD19-positive non-Hodgkin lymphoma (NHL) patients. 1 Diffuse large B lymphoma (DLBCL), follicular lymphoma (FL), primary mediastinal B-cell lymphoma (PMBCL) patients meet one of the following conditions: I Patients who have relapsed or are refractory after at least 2 previous treatments; II Patients who have relapsed after transplantation. 2 Patients with relapsed or refractory mantle cell lymphoma after at least one treatment.
- Patients must have evaluable disease evidence;
- Age ≥ 18 years old;
- The expected life span is more than 3 months;
- ECOG score 0-2 points (see Attachment 2);
Key exclusion criteria (13 listed)
- Patients with high-risk organ involvement: tumors invade one of the central nervous system, gastrointestinal tract, lungs, pericardium, and large vessels;
- Those who have a graft-versus-host response and need to use immunosuppressive drugs; or who have a disease of the autoimmune system;
- Use chemotherapy or radiotherapy within 3 days before the blood collection period;
- Those who have used systemic steroids within the 5 days prior to the blood sampling period (except recently or currently using inhaled steroids);
- Use stimulating bone marrow hematopoietic cells to produce drugs (whitening needles, etc.) within 5 days before the blood collection period;
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 |
|---|---|---|
| IM19CAR-T cells | Biological | IM19 CAR-T cells |
| FludarabineTwo days before cell infusion, all patients will be treated with fludarabine for 3 days | Drug | IM19 CAR-T cells |
| CyclophosphamideTwo days before cell infusion, all patients will be treated with Cyclophosphamide for 3 days | Drug | IM19 CAR-T cells |
Primary outcome
Occurrence of study related adverse events
Time frame: 2 years
>= 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 16 Jul 2018.
- Derived from this study: PubMed 34515338Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.
- Derived from this study: PubMed 33632155Ying Z, He T, Wang X, Zheng W, Lin N, Tu M, Xie Y, Ping L, Zhang C, Liu W, Deng L, Wu M, Feng F, Leng X, Du T, Qi F, Hu X, Ding Y, Lu XA, Song Y, Zhu J. Distribution of chimeric antigen receptor-modified T cells against CD19 in B-cell malignancies. BMC Cancer. 2021 Feb 25;21(1):198. doi: 10.1186/s12885-021-07934-1.
- Individual participant dataSharing planned: No
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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.
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, Fludarabine and Cyclophosphamide in people with Non Hodgkin Lymphoma, 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 7 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: status not confirmed, as of the sponsor's last update on 16 Jul 2018. 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 NCT03528421, 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 16 Jul 2018.