Multiple MyelomaEarly Phase 1NCT04412889
A Study of BCMA/CD19 Dual-Target CAR-T Cell Immunotherapy for Relapsed or Refractory MM
A Early Phase 1 study testing BCMA/CD19 dual-target CAR-T cell immunotherapy in people with Multiple Myeloma, run by Hebei Yanda Ludaopei Hospital at 1 site in China.
Trial summary
The study is an early, open, single-centered trial. The aim of this study is to evaluate the safety and tolerance of BCMA/CD19 dual-target CAR-T cell immunotherapy in relapsed or refractory MM. The study will include 18 subjects to receive BCMA/CD19 dual-target CAR-T cell immunotherapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- BCMA/CD19 dual-target CAR-T cell immunotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- Jun 2020to Dec 2022
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-70 years;
- Diagnosis of relapsed or refractory multiple myeloma (MM): 1) Received at least 3 prior lines of treatment, including proteasome inhibitor (such as bortezomib and carfilzomib) and immunomodulator (such as lenalidomide and pomalidomide), and undergone at least 1 complete cycle of treatment for each line, unless PD was documented as the best response to the regimen; 2) Resistant to proteasome inhibitor and immunomodulator, PD in 60 days after treatment;
- Measurable disease at screening as defined by any of the following: 1) Serum monoclonal paraprotein (M-protein) level ≥10 g/L or urine M-protein level ≥200 mg/24 hours or; 2) Light chain MM without measurable disease in the serum or the urine: serum immunoglobulin free light chain ≥10 mg/dL and abnormal serum immunoglobulin kappa/lambda free light chain ratio or; 3) Plasma cell percentage in bone marrow ≥30%;
- Histologically confirmed positive expression of CD19 and/or BCMA ≤3 months prior to enrollment;
- Eastern cooperative oncology group (ECOG) performance status of 0 to 1;
- Life expectancy≥12 weeks;
Show all 10Show fewer
- Adequate organ function is defined as: 1) Hemoglobin≥6.0g/dL (did not receive red blood cell transfusion ≤7 days prior to laboratory tests); 2) Platelet count >50×10^9/L (did not receive blood transfusion ≤7 days prior to laboratory tests); 3) Absolute neutrophil count (ANC) ≥0.75×10^9/L (did not receive supportive treatment ≤7 days prior to laboratory tests); 4) Bilirubin <2×ULN, expect for subjects with congenital hyperbilirubinemia (for subjects with Gilbert's syndrome, direct bilirubin≤2×ULN); 5) Creatinine clearance (according to modification of diet in renal disease formulas or 24h urine collection result) ≥40 mL/min/1.73m^2; 6) Alanine aminotransferase/aspartate aminotransferase (ALT/AST) <2.5×ULN; 7) Corrected serum calcium ≤14 mg/dL (≤3.5 mmol/L), or free calcium ion ≤6.5 mg/dL (≤1.6 mmol/L); 8) Oxygen saturation >92% on non-oxygen-therapy state; 9) Left ventricular ejection fraction (LVEF)>50%, no evidence of clinically significant pericardial effusion as determined by an echocardiography;
- Meet the requirements of peripheral blood mononuclear cells (PBMC) collection of the site;
- Females must not be in pregnancy nor in lactation. Form signing the ICF to the end of the trial, females of childbearing potential and males must use efficient contraception;
- Sign the informed consent form (ICF), can understand and adhere to the procedures and requirements in this study.
Who cannot join
- Solitary plasmacytoma;
- Central nervous system (CNS) involvement;
- Previous other CAR-T or other gene-editing T cell therapy ≤8 weeks prior to enrollment (not applicable to subject received CAR-T second infusion);
- Previous allogeneic stem cell transplant; previous autologous stem cell transplant ≤12 weeks prior to enrollment;
- Any result of the following virology tests is positive: HIV；HCV；HBsAg；HBcAg；TPPA;
- Concomitant malignancy that require treatment or do not achieve complete remission in 3 years prior to enrollment other than: cured non-melanoma skin cancer, cervical carcinoma in situ, prostate cancer that do not require treatment, other malignancy whose disease-free survival exceeds 5 years;
Show all 17Show fewer
- Toxicities related to previous therapy did not relieved to ≤1 grade, except hematological toxicity and alopecia;
- Live vaccine ≤4 weeks prior to enrollment;
- Other investigational drug ≤4 weeks prior to enrollment;
- Surgical operation that require general anesthesia happened ≤4 weeks prior to enrollment, or did not be fully recovered and clinically stable prior to enrollment, or be anticipated to undergo major surgical operation that require general anesthesia during the study;
- Any unstable cardiovascular disease happened ≤6 months prior to enrollment, including but not limited to, unstable angina, myocardial infarction, heart failure (NYHA grade ≥ III grade), severe arrhythmia that require drug interference, cardiac angioplasty/coronary stent implantation/cardiac bypass surgery ≤6 months prior to enrollment;
- Presence of active autoimmune disease (including but not limited to, systemic lupus erythematosus, sjogren syndrome, rheumatoid arthritis, inflammatory bowel disease, hypothyroidism which can be controlled by thyroid hormone replacement therapy is an exception);
- Presence of CNS disease or disease history, including epilepsy, cerebral ischemia/bleeding, dementia, cerebellar disease (not applicable to subject received CAR-T second infusion, unless 4 grade ICANS happened after CAR-T first infusion);
- Presence of complication that require systemic corticosteroids or other immunosuppressive drugs therapy during the trial in researcher's judgement;
- Known life-threatening hypersensitivity to cyclophosphamide or fludarabine, or presence of other intolerant conditions, or severe allergic constitution;
- Presence of plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome or primary amyloidosis;
- Any other condition that researcher think it is inappropriate for the subject to anticipate the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study of B-Cell Maturation Antigen/Cluster of Differentiation 19 Dual-Target Chimeric Antigen Receptor T Cell Immunotherapy for Relapsed or Refractory Multiple Myeloma
The study is an early, open, single-centered trial. The aim of this study is to evaluate the safety and tolerance of BCMA/CD19 dual-target CAR-T cell immunotherapy in relapsed or refractory MM. The study will include 18 subjects to receive BCMA/CD19 dual-target CAR-T cell immunotherapy.
- Conditions
- Multiple Myeloma
- Being tested
- BCMA/CD19 dual-target CAR-T cell immunotherapy
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCMA/CD19 dual-target CAR-T cell immunotherapyBiological
The intervention is a CAR-T cell immunotherapy targeted CD19 and BCMA. The dosage ranges from 2×10^5 to 1×10^6 CAR+T/Kg.
| Study group | Role | What they receive |
|---|---|---|
| CAR-T treatment group | Experimental | The patients will receive BCMA/CD19 dual-target CAR-T cell treatment. BCMA/CD19 dual-target CAR-T cell dosage ranges from 2×10^5 to 1×10^6 CAR+T/Kg. Receives: Biological: BCMA/CD19 dual-target CAR-T cell immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type and incidence of dose-limiting toxicity (DLT), incidence and severity of treatment related adverse event (AE), cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome, ICANS) (safety and tolerability)
AE will be collected and graded according to American Society for Transplantation and Cellular Therapy (ASTCT) consensus (for CRS/ICANS) and CTCAE v5.0(for AE except CRS/ICANS)
Measured: 2 years
Secondary outcomes (7)
CAR copies in peripheral blood, bone marrow, extramedullary plasmacytoma, and cerebrospinal fluid (CSF) (amplification and persistence)
CAR copies in peripheral blood, bone marrow, extramedullary plasmacytoma and CSF will be measured by quantitative polymerase chain reaction (qPCR) in 2 years.
Measured: 2 years
CAR cells in peripheral blood, bone marrow and CSF (amplification and persistence)
CAR cells in peripheral blood, bone marrow and CSF will be measured by flow cytometry (FCM) in 2 years.
Measured: 2 years
Objective response rate (ORR) (efficacy)
ORR will be calculated as the percentage of patients who achieved partial response (PR) or better.
Measured: 6 months
Duration of response (DOR) (efficacy)
DOR will be calculated as the time from the first assessment of PR or better to the first assessment of progressive disease (PD) or death from any cause.
Measured: 2 years
Progression-free survival (PFS)(efficacy)
PFS will be calculated as the time from CAR-T infusion to disease progression or death from any cause (whichever occurs first).
Measured: 2 years
Overall survival (OS)(efficacy)
OS will be calculated as the time from CAR-T infusion to death from any cause.
Measured: 2 years
Concentration of anti-CAR antibody after infusion (humoral immune response)
After CAR-T infusion, anti-CAR antibody in peripheral blood will be measured in 2 years
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 posted2 Jun 2020
- Study startJun 2020 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies 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
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Yanda Ludaopei Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Gracell Biotechnology Ltd.
- Responsible party
- Sponsor
- Investigators
- Peihua Lu, PhD&MD, Principal investigator, Hebei Yanda Ludaopei Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04412889
- Sponsor's protocol ID
- PGC010
- Status last verified
- May 2020
- First submitted
- 21 May 2020
- Last updated
- 2 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of B-Cell Maturation Antigen/Cluster of Differentiation 19 Dual-Target Chimeric Antigen Receptor T Cell Immunotherapy for Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT04412889
- Acronym / sponsor ID
- PGC010
- Conditions
- Multiple Myeloma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Hebei Yanda Ludaopei HospitalUniversity, hospital or other
- Collaborators
- Gracell Biotechnology Ltd.
- Study start
- Jun 2020 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 2 Jun 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.
The study is an early, open, single-centered trial. The aim of this study is to evaluate the safety and tolerance of BCMA/CD19 dual-target CAR-T cell immunotherapy in relapsed or refractory MM. The study will include 18 subjects to receive BCMA/CD19 dual-target CAR-T cell immunotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAR-T treatment group | Experimental | Biological: BCMA/CD19 dual-target CAR-T cell immunotherapyThe patients will receive BCMA/CD19 dual-target CAR-T cell treatment. BCMA/CD19 dual-target CAR-T cell dosage ranges from 2×10^5 to 1×10^6 CAR+T/Kg. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Aged 18-70 years;
- Diagnosis of relapsed or refractory multiple myeloma (MM): 1) Received at least 3 prior lines of treatment, including proteasome inhibitor (such as bortezomib and carfilzomib) and immunomodulator (such as lenalidomide and pomalidomide), and undergone at least 1 complete cycle of treatment for each line, unless PD was documented as the best response to the regimen; 2) Resistant to proteasome inhibitor and immunomodulator, PD in 60 days after treatment;
- Measurable disease at screening as defined by any of the following: 1) Serum monoclonal paraprotein (M-protein) level ≥10 g/L or urine M-protein level ≥200 mg/24 hours or; 2) Light chain MM without measurable disease in the serum or the urine: serum immunoglobulin free light chain ≥10 mg/dL and abnormal serum immunoglobulin kappa/lambda free light chain ratio or; 3) Plasma cell percentage in bone marrow ≥30%;
- Histologically confirmed positive expression of CD19 and/or BCMA ≤3 months prior to enrollment;
- Eastern cooperative oncology group (ECOG) performance status of 0 to 1;
Key exclusion criteria (17 listed)
- Solitary plasmacytoma;
- Central nervous system (CNS) involvement;
- Previous other CAR-T or other gene-editing T cell therapy ≤8 weeks prior to enrollment (not applicable to subject received CAR-T second infusion);
- Previous allogeneic stem cell transplant; previous autologous stem cell transplant ≤12 weeks prior to enrollment;
- Any result of the following virology tests is positive: HIV；HCV；HBsAg；HBcAg；TPPA;
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 |
|---|---|---|
| BCMA/CD19 dual-target CAR-T cell immunotherapyThe intervention is a CAR-T cell immunotherapy targeted CD19 and BCMA. The dosage ranges from 2×10^5 to 1×10^6 CAR+T/Kg. | Biological | CAR-T treatment group |
Primary outcome
Type and incidence of dose-limiting toxicity (DLT), incidence and severity of treatment related adverse event (AE), cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome, ICANS) (safety and tolerability)
Time frame: 2 years
AE will be collected and graded according to American Society for Transplantation and Cellular Therapy (ASTCT) consensus (for CRS/ICANS) and CTCAE v5.0(for AE except CRS/ICANS)
7 secondary outcomes
CAR copies in peripheral blood, bone marrow, extramedullary plasmacytoma, and cerebrospinal fluid (CSF) (amplification and persistence)
Time frame: 2 years
CAR cells in peripheral blood, bone marrow and CSF (amplification and persistence)
Time frame: 2 years
Objective response rate (ORR) (efficacy)
Time frame: 6 months
Duration of response (DOR) (efficacy)
Time frame: 2 years
Progression-free survival (PFS)(efficacy)
Time frame: 2 years
Overall survival (OS)(efficacy)
Time frame: 2 years
Concentration of anti-CAR antibody after infusion (humoral immune response)
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 2 Jun 2020.
Related trials for Multiple Myeloma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
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, PhD&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 Early Phase 1 study testing BCMA/CD19 dual-target CAR-T cell immunotherapy in people with Multiple Myeloma, run by Hebei Yanda Ludaopei Hospital 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 10 inclusion and 17 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 2 Jun 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 Peihua Lu, PhD&MD (+86-0316-3306393, Peihua_lu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type and incidence of dose-limiting toxicity (DLT), incidence and severity of treatment related adverse event (AE), cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome, ICANS) (safety and tolerability) (time frame: 2 years). 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 2 Jun 2020.