Refractory Indolent Adult Non-Hodgkin LymphomaEarly Phase 1NCT04626739
CAR-T Cells in Treating Patients With Relapsed or Refractory NHL
A Early Phase 1 study testing CD19 CAR-T, CD22 CAR-T and CD19+CD22 CAR-T in people with Refractory Indolent Adult Non-Hodgkin Lymphoma, run by Hebei Senlang Biotechnology Inc., Ltd. at 1 site in China.
Trial summary
This is an open, single-arm, phase I clinical study to evaluate efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) in the treatment of Non-hodgkin's lymphoma. A total of 100 patients are planned to be enrolled over a period of 3 years. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Refractory Indolent Adult Non-Hodgkin Lymphoma
- What is being tested?
- CD19 CAR-T, CD22 CAR-T and CD19+CD22 CAR-T
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2020to 30 Mar 2023
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fully understand and voluntarily sign the informed consent, and are willing and able to comply with the visit, treatment protocol, laboratory examination and other requirements of the study as set out in the trial procedure sheet;
- Cd19-positive R/R NHL patients: recurrent or refractory patients were defined as diffuse large B cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), mucosa-associated lymphoid tissue lymphoma (MALTL), and Burkit lymphoma (BL) diagnosed by histopathology.
- To standard treatment for primary drug resistance, or after treatment for at least two line standard specification treatment of PD, or the last treatment effect for SD and duration less than 6 months, or CD20 positive patients by the resistance against CD20 single treatment is invalid or has a relapse, or autologous hematopoietic stem cell transplantation in PD or 12 months after the confirmed by biopsy has a relapse, or to save patients after autologous hematopoietic stem cell transplantation for at the end of the line no ease or relapse after treatment;
- There should be at least one measurable tumor focal point;
- Karnofsky [2] score 50 or more;
- Tumor cells were CD19 positive by immunohistochemistry or flow cytometry;
- The expected survival time is greater than 3 months;
- Pregnancy tests for women of childbearing age must be negative; Both men and women should agree to use effective contraceptives during treatment and for the following 1 year;
Who cannot join
- Serious cardiac insufficiency, left ventricular ejection fraction<50;
- Has a history of severe pulmonary function damaging;
- Merging other malignant tumor;
- Merging uncontrolled infection;
- Merging the metabolic diseases (except diabetes);
- Merging severe autoimmune diseases or immunodeficiency disease;
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- patients with active hepatitis B or hepatitis C;
- patients with HIV infection;
- Has a history of serious allergies on Biological products (including antibiotics);
- Happened in 3 ~ 4 acute GvHD after allogeneic hematopoietic stem cell transplantation on recurring patients;
- Pregnancy or lactation women;
- 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
No.2 Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
Jianqiang Li, PhD & MD, +86311-89928689, limmune@gmail.com
Jianmin Luo, PhD & MD, +86311-66002304
About this study
Official title: An Open, Uncontrolled, Multicenter Clinical Trial to Explore the Safety, Efficacy, and Remission Phase of Chimeric Antigen Receptor T Cell (CAR-T) in the Treatment of Relapsed Refractory (R/R) Non-Hodgkin Lymphoma (NHL)
This is an open, single-arm, phase I clinical study to evaluate efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) in the treatment of Non-hodgkin's lymphoma. A total of 100 patients are planned to be enrolled over a period of 3 years.
Read the detailed description
Chimeric antigen receptor (CAR)-modified T cells targeted against CD19 have demonstrated unprecedented successes in treating patients with hematopoietic and lymphoid malignancies. In this study, investigators will evaluate their safety and efficacy in patients with different types of hematopoietic and lymphoid malignancies. The primary goal is safety assessment including cytokine storm response and any other adverse effects. In addition, tumor targeting and disease status after treatment will also be evaluated.
- Being tested
- CD19 CAR-T, CD22 CAR-T, CD19+CD22 CAR-T, Fludarabine, Cyclophosphamide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD19 CAR-TDrug
Also called Senl_19
CD19 CAR-T for CD19 positive R/R non-Hodgkin lymphoma
CD22 CAR-TDrug
Also called Senl_22
CD22 CAR-T for CD22 positive R/R non-Hodgkin lymphoma
CD19+CD22 CAR-TDrug
Also called Senl_19+22
CD19+CD22 CAR-T for CD19 positive and CD22 positive R/R non-Hodgkin lymphoma
FludarabineDrug
Also called flu
25mg/㎡ for D-4、D-3 and D-2
CyclophosphamideDrug
Also called ctx
500mg/㎡ for D-3 and D-2
| Study group | Role | What they receive |
|---|---|---|
| volunteers | Experimental | The patient voluntarily signs the informed consent, and the patient meets the entry criteria to diagnose patients with Relapsed Refractory (R/R) non-Hodgkin lymphoma Receives: Drug: CD19 CAR-T; Drug: CD22 CAR-T; Drug: CD19+CD22 CAR-T; Drug: Fludarabine; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Severe/Adverse Events as a Measure of Safety
Number of Participants with Severe/Adverse Events as a Measure of Safety
Measured: 28 days
CAR-T Cell expansion level
Copies numbers of CAR in peripheral blood(PB) and/or bone marrow(BM)
Measured: 24 months
Secondary outcomes (2)
Objective response rate of complete remission and partial remission
Objective response rate of complete remission and partial remission
Measured: 24 months
Overall survival time
Overall survival time
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start1 Apr 2020
- Primary completion30 Mar 2023 (estimated)
- Study completion30 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Indolent Adult 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Senlang Biotechnology Inc., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianmin luo, PhD&MD, Principal investigator, The Second Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04626739
- Sponsor's protocol ID
- CAR-T for NHL
- Status last verified
- Nov 2020
- First submitted
- 6 Nov 2020
- Last updated
- 13 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Uncontrolled, Multicenter Clinical Trial to Explore the Safety, Efficacy, and Remission Phase of Chimeric Antigen Receptor T Cell (CAR-T) in the Treatment of Relapsed Refractory (R/R) Non-Hodgkin Lymphoma (NHL)
- ClinicalTrials.gov ID
- NCT04626739
- Acronym / sponsor ID
- CAR-T for NHL
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hebei Senlang Biotechnology Inc., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 30 Mar 2023 (estimated)
- Study completion
- 30 Mar 2023 (estimated)
- First posted
- 13 Nov 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.
This is an open, single-arm, phase I clinical study to evaluate efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) in the treatment of Non-hodgkin's lymphoma. A total of 100 patients are planned to be enrolled over a period of 3 years.
Detailed description
Chimeric antigen receptor (CAR)-modified T cells targeted against CD19 have demonstrated unprecedented successes in treating patients with hematopoietic and lymphoid malignancies. In this study, investigators will evaluate their safety and efficacy in patients with different types of hematopoietic and lymphoid malignancies. The primary goal is safety assessment including cytokine storm response and any other adverse effects. In addition, tumor targeting and disease status after treatment will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| volunteers | Experimental | Drug: CD19 CAR-T, Drug: CD22 CAR-T, Drug: CD19+CD22 CAR-T, Drug: Fludarabine, Drug: CyclophosphamideThe patient voluntarily signs the informed consent, and the patient meets the entry criteria to diagnose patients with Relapsed Refractory (R/R) non-Hodgkin lymphoma |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Fully understand and voluntarily sign the informed consent, and are willing and able to comply with the visit, treatment protocol, laboratory examination and other requirements of the study as set out in the trial procedure sheet;
- Cd19-positive R/R NHL patients: recurrent or refractory patients were defined as diffuse large B cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), mucosa-associated lymphoid tissue lymphoma (MALTL), and Burkit lymphoma (BL) diagnosed by histopathology.
- To standard treatment for primary drug resistance, or after treatment for at least two line standard specification treatment of PD, or the last treatment effect for SD and duration less than 6 months, or CD20 positive patients by the resistance against CD20 single treatment is invalid or has a relapse, or autologous hematopoietic stem cell transplantation in PD or 12 months after the confirmed by biopsy has a relapse, or to save patients after autologous hematopoietic stem cell transplantation for at the end of the line no ease or relapse after treatment;
- There should be at least one measurable tumor focal point;
- Karnofsky [2] score 50 or more;
Key exclusion criteria (12 listed)
- Serious cardiac insufficiency, left ventricular ejection fraction<50;
- Has a history of severe pulmonary function damaging;
- Merging other malignant tumor;
- Merging uncontrolled infection;
- Merging the metabolic diseases (except diabetes);
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 |
|---|---|---|
| CD19 CAR-TAlso: Senl_19CD19 CAR-T for CD19 positive R/R non-Hodgkin lymphoma | Drug | volunteers |
| CD22 CAR-TAlso: Senl_22CD22 CAR-T for CD22 positive R/R non-Hodgkin lymphoma | Drug | volunteers |
| CD19+CD22 CAR-TAlso: Senl_19+22CD19+CD22 CAR-T for CD19 positive and CD22 positive R/R non-Hodgkin lymphoma | Drug | volunteers |
| FludarabineAlso: flu25mg/㎡ for D-4、D-3 and D-2 | Drug | volunteers |
| CyclophosphamideAlso: ctx500mg/㎡ for D-3 and D-2 | Drug | volunteers |
Primary outcome
Number of Participants with Severe/Adverse Events as a Measure of Safety
Time frame: 28 days
Number of Participants with Severe/Adverse Events as a Measure of Safety
CAR-T Cell expansion level
Time frame: 24 months
Copies numbers of CAR in peripheral blood(PB) and/or bone marrow(BM)
2 secondary outcomes
Objective response rate of complete remission and partial remission
Time frame: 24 months
Overall survival time
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- 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.
Jianmin luo, PhD&MD principal investigator
The Second Hospital of Hebei Medical University
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 CD19 CAR-T, CD22 CAR-T and CD19+CD22 CAR-T in people with Refractory Indolent Adult Non-Hodgkin Lymphoma, run by Hebei Senlang Biotechnology Inc., 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 8 inclusion and 12 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 13 Nov 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 Jianqiang Li, Phd&MD (86-311-82970975, hr@senlangbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Severe/Adverse Events as a Measure of Safety (time frame: 28 days). The study lists 2 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 13 Nov 2020.