Multiple Myeloma in RelapseEarly Phase 1NCT04603872
CAR-T Cells Combined With Dasatinib for Patients With Relapsed and/or Refractory B-cell Hematological Malignancies
A Early Phase 1 study testing CD19/BCMA Targeted CAR T-cells and dasatinib and CD19/BCMA Targeted CAR T-cells in people with Multiple Myeloma in Relapse and Multiple Myeloma, Refractory, run by Zhejiang University at 1 site in China.
Trial summary
A Study of CD19/BCMA-targeted CAR-T Cells Combined With Dasatinib for Patients With Relapsed and/or Refractory B-cell Acute Lymphoblastic Leukemia, B-cell Non-Hodgkin's Lymphoma and Multiple Myeloma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Myeloma in Relapse, Multiple Myeloma, Refractory, Acute Lymphoblastic Leukemia, in Relapse
- What is being tested?
- CD19/BCMA Targeted CAR T-cells and dasatinib and CD19/BCMA Targeted CAR T-cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2020to 1 Nov 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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
- Histologically confirmed diagnosis of CD19+ ALL, CD19+ NHL, or BCMA+ MM per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines (2020.v2);
- Relapsed or refractory B cell hematological malignancies (meeting one of the following conditions):
- CR not achieved after standardized chemotherapy;
- CR achieved following the first induction, but CR duration is less than 12 months;
- Ineffectively after first or multiple remedial treatments;
- 2 or more relapses;
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- Relapse after hematopoietic stem cell transplantation;
- Extramedullary leisions which were ineffective to radiotherapy or chemotherapy;
- Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit ofnormal, creatinine ≤ 176.8 umol/L;
- Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%;
- No active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%;
- Estimated survival time ≥ 12 weeks;
- ECOG performance status 0 to 2;
- Women of childbearing age had negative pregnancy test during screening period and before administration, and agreed to take effective contraceptive measures at least one year after infusion.
- Patients volunteer to participate in the study and sign the informed consent.
Who cannot join
- Subjects with any of the following exclusion criteria were not eligible for this trial:
- History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular, hemorrhagic diseases;
- Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
- Pregnant (or lactating) women;
- Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
- Active infection of hepatitis B virus or hepatitis C virus;
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- Concurrent therapy with systemic steroids within 2 weeks prior toscreening, except for the patients recently or currently receiving in haledsteroids;
- Previously treated with any CAR-T cell product or other genetically-modified T cell therapies;
- Creatinine >2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin >2.0 mg/dl;
- Other uncontrolled diseases that were not suitable for this trial;
- Patients with HIV infection;
- Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Hospital of Zhejiang Medical Colleage Zhejiang University
Hangzhou, Zhejiang, 310003
He Huang, PhD, 86-13605714822, hehuangyu@126.com
About this study
Official title: Clinical Trial for the Safety and Efficacy of CD19/BCMA-targeted CAR-T Cells Combined With Dasatinib for Patients With Relapsed and/or Refractory B-cell Acute Lymphoblastic Leukemia, B-cell Non-Hodgkin's Lymphoma and Multiple Myeloma
A Study of CD19/BCMA-targeted CAR-T Cells Combined With Dasatinib for Patients With Relapsed and/or Refractory B-cell Acute Lymphoblastic Leukemia, B-cell Non-Hodgkin's Lymphoma and Multiple Myeloma.
Read the detailed description
This is a double-arm, single-center study. This study is indicated for relapsed and/or refractory B-cell acute lymphoblastic leukemia, B-cell non-Hodgkin's lymphoma and multiple myeloma, the selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 120 patients will be enrolled for this trial. Primary objective is to explore the safety.
- Conditions
- Multiple Myeloma in Relapse, Multiple Myeloma, Refractory, Acute Lymphoblastic Leukemia, in Relapse, Acute Lymphocytic Leukaemia Refractory, Non-Hodgkin's Lymphoma, Relapsed, Non-Hodgkin's Lymphoma Refractory
- Being tested
- CD19/BCMA Targeted CAR T-cells and dasatinib, CD19/BCMA Targeted CAR T-cells
- Keywords
- Acute Lymphoblastic Leukemia, Non-Hodgkin's Lymphoma, Multiple Myeloma, CAR T-cell therapy, Dasatinib
- Medical subject headings
- Multiple Myeloma, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Non-Hodgkin, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD19/BCMA Targeted CAR T-cells and dasatinibDrug
Also called Administration of CD19/BCMA Targeted CAR T-cells and dasatinib
Each subject receive CS1 Targeted CAR T-cells by intravenous infusion, and the dasatinib was combined according to the presumed regimens.
CD19/BCMA Targeted CAR T-cellsDrug
Also called CD19/BCMA Targeted CAR T-cells infusion
Each subject receive CS1 Targeted CAR T-cells by intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| Administration of CD19/BCMA Targeted CAR T-cells and dasatinib | Experimental | Dose levels of CAR-T cells are based on clinical trials of similar foreign products. Meanwhile, dasatinib would be combined as the following regimens: 1) Dasatinib preconditioning CAR-T cells during the manufacturing; 2) Dasatinib for the intervention of cytokine release storm after CAR-T cell infusion; 3) Dasatinib for the intervention of neurotoxicities after CAR-T cell infusion; 4) Dasatinib for the phase of CAR-T cell decreasing. Receives: Drug: CD19/BCMA Targeted CAR T-cells and dasatinib |
| Administration of CD19/BCMA Targeted CAR T-cells | Experimental | Dose levels of CAR-T cells are based on clinical trials of similar foreign products. Receives: Drug: CD19/BCMA Targeted CAR T-cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT)
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Measured: Baseline up to 28 days after CAR T-cells infusion
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of treatment-emergent adverse events [Safety and Tolerability]
Measured: Up to 2 years after CAR T-cells infusion
Secondary outcomes (11)
B-cell acute lymphocytic leukemia(B-ALL), Overall response rate (ORR)
Assessment of ORR (ORR = CR + CRi) at Month 6, 12, 18 and 24
Measured: At Month 1, 3, 6, 12, 18 and 24
B-ALL, Overall survival (OS)
From the first infusion of CAR-T cells to death or the last visit
Measured: Up to 2 years after CAR-T cells infusion
B-ALL, Event-free survival (EFS)
From the first infusion of CAR-T cells to the occurrence of any event, including death, relapse orgene relapse, disease progression (any one occurs first), and the last visit
Measured: Up to 2 years after CAR-T cells infusion
B cell non-hodgkin's lymphoma (B-NHL), Overall response rate (ORR)
Assessment of ORR (ORR = CR + PR) per Lugano 2014 criteria
Measured: At Week 4, 12, and Month 6, 12, 18, 24
B-NHL, disease control rate (DCR)
Assessment of DCR (DCR=CR+PR+SD) per Lugano 2014 criteria
Measured: At Week 12 and Month 6, 12, 18, 24
Multiple myeloma (MM), Overall response rate (ORR)
Assessment of ORR at Day 28
Measured: At Day 28
MM, Overall survival (OS)
Assessment of OS at Month 6, 12, 24
Measured: At Month 6, 12, 24
Quality of life
Assessment using European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) scale [For item1-28: max score: 112, min score: 28, higher scores mean a better outcome; for item 28-29: max score: 14, min score: 2, higher scores mean a worse outcome] to measure Quality of life at Baseline, Month 1, 3, 6, 9 and 12
Measured: At Baseline, Month 1, 3, 6, 9 and 12
Activities of Daily Living (ADL) score
Assessment using Activities of Daily Living (ADL) scale (Barthel Index) [max score: 100, min score: 0, higher scores mean a better outcome] at Baseline, Month 1, 3, 6, 9 and 12
Measured: At Baseline, Month 1, 3, 6, 9 and 12
Instrumental Activities of Daily Living (IADL) score
Assessment of Instrumental Activities of Daily Living (IADL) scale [max score: 56, min score: 14, higher scores mean a worse outcome] at Baseline, Month 1, 3, 6, 9 and 12
Measured: At Baseline, Month 1, 3, 6, 9 and 12
Hospital Anxiety and Depression Scale (HADS) score
Assessment using Hospital Anxiety and Depression Scale (HADS) [max score: 42, min score: 0, higher scores mean a worse outcome] at Baseline, Month 1, 3, 6, 9 and 12
Measured: At Baseline, Month 1, 3, 6, 9 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start1 Nov 2020 (estimated)
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma in RelapseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Yake Biotechnology Ltd.
- Responsible party
- Principal investigator, He Huang, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04603872
- Sponsor's protocol ID
- DASA001
- Status last verified
- Oct 2020
- First submitted
- 21 Oct 2020
- Last updated
- 28 Oct 2020
- 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 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial for the Safety and Efficacy of CD19/BCMA-targeted CAR-T Cells Combined With Dasatinib for Patients With Relapsed and/or Refractory B-cell Acute Lymphoblastic Leukemia, B-cell Non-Hodgkin's Lymphoma and Multiple Myeloma
- ClinicalTrials.gov ID
- NCT04603872
- Acronym / sponsor ID
- DASA001
- Conditions
- Multiple Myeloma in Relapse, Multiple Myeloma, Refractory, Acute Lymphoblastic Leukemia, in Relapse, Acute Lymphocytic Leukaemia Refractory, Non-Hodgkin's Lymphoma, Relapsed, Non-Hodgkin's Lymphoma Refractory
- Keywords
- Acute Lymphoblastic Leukemia, Non-Hodgkin's Lymphoma, Multiple Myeloma, CAR T-cell therapy, Dasatinib
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Yake Biotechnology Ltd.
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 27 Oct 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.
A Study of CD19/BCMA-targeted CAR-T Cells Combined With Dasatinib for Patients With Relapsed and/or Refractory B-cell Acute Lymphoblastic Leukemia, B-cell Non-Hodgkin's Lymphoma and Multiple Myeloma.
Detailed description
This is a double-arm, single-center study. This study is indicated for relapsed and/or refractory B-cell acute lymphoblastic leukemia, B-cell non-Hodgkin's lymphoma and multiple myeloma, the selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 120 patients will be enrolled for this trial. Primary objective is to explore the safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Administration of CD19/BCMA Targeted CAR T-cells and dasatinib | Experimental | Drug: CD19/BCMA Targeted CAR T-cells and dasatinibDose levels of CAR-T cells are based on clinical trials of similar foreign products. Meanwhile, dasatinib would be combined as the following regimens: 1) Dasatinib preconditioning CAR-T cells during the manufacturing; 2) Dasatinib for the intervention of cytokine release storm after CAR-T cell infusion; 3) Dasatinib for the intervention of neurotoxicities after CAR-T cell infusion; 4) Dasatinib for the phase of CAR-T cell decreasing. |
| Administration of CD19/BCMA Targeted CAR T-cells | Experimental | Drug: CD19/BCMA Targeted CAR T-cellsDose levels of CAR-T cells are based on clinical trials of similar foreign products. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Histologically confirmed diagnosis of CD19+ ALL, CD19+ NHL, or BCMA+ MM per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines (2020.v2);
- Relapsed or refractory B cell hematological malignancies (meeting one of the following conditions):
- Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit ofnormal, creatinine ≤ 176.8 umol/L;
- Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%;
- No active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%;
Key exclusion criteria (12 listed)
- History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular, hemorrhagic diseases;
- Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
- Pregnant (or lactating) women;
- Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
- Active infection of hepatitis B virus or hepatitis C virus;
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/BCMA Targeted CAR T-cells and dasatinibAlso: Administration of CD19/BCMA Targeted CAR T-cells and dasatinibEach subject receive CS1 Targeted CAR T-cells by intravenous infusion, and the dasatinib was combined according to the presumed regimens. | Drug | Administration of CD19/BCMA Targeted CAR T-cells and dasatinib |
| CD19/BCMA Targeted CAR T-cellsAlso: CD19/BCMA Targeted CAR T-cells infusionEach subject receive CS1 Targeted CAR T-cells by intravenous infusion. | Drug | Administration of CD19/BCMA Targeted CAR T-cells |
Primary outcome
Dose-limiting toxicity (DLT)
Time frame: Baseline up to 28 days after CAR T-cells infusion
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Up to 2 years after CAR T-cells infusion
Incidence of treatment-emergent adverse events [Safety and Tolerability]
11 secondary outcomes
B-cell acute lymphocytic leukemia(B-ALL), Overall response rate (ORR)
Time frame: At Month 1, 3, 6, 12, 18 and 24
B-ALL, Overall survival (OS)
Time frame: Up to 2 years after CAR-T cells infusion
B-ALL, Event-free survival (EFS)
Time frame: Up to 2 years after CAR-T cells infusion
B cell non-hodgkin's lymphoma (B-NHL), Overall response rate (ORR)
Time frame: At Week 4, 12, and Month 6, 12, 18, 24
B-NHL, disease control rate (DCR)
Time frame: At Week 12 and Month 6, 12, 18, 24
Multiple myeloma (MM), Overall response rate (ORR)
Time frame: At Day 28
MM, Overall survival (OS)
Time frame: At Month 6, 12, 24
Quality of life
Time frame: At Baseline, Month 1, 3, 6, 9 and 12
Activities of Daily Living (ADL) score
Time frame: At Baseline, Month 1, 3, 6, 9 and 12
Instrumental Activities of Daily Living (IADL) score
Time frame: At Baseline, Month 1, 3, 6, 9 and 12
Hospital Anxiety and Depression Scale (HADS) score
Time frame: At Baseline, Month 1, 3, 6, 9 and 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
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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.
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/BCMA Targeted CAR T-cells and dasatinib and CD19/BCMA Targeted CAR T-cells in people with Multiple Myeloma in Relapse and Multiple Myeloma, Refractory, run by Zhejiang 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 15 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: looking for participants now, as of the sponsor's last update on 28 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact He Huang, PhD (86-13605714822, hehuangyu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (DLT) (time frame: Baseline up to 28 days after CAR T-cells infusion). 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 28 Oct 2020.