Multiple MyelomaEarly Phase 1NCT04182581
A Study of BCMA/CD19 Dual-Target CAR-T Cell Immunotherapy for Relapsed or Refractory Multiple Myeloma
A Early Phase 1 study testing BCMA/CD19 Dual-Target CAR-T in people with Multiple Myeloma, run by Xijing Hospital at 1 site in China.
Trial summary
The study is an early, open, single-centered trial. The purpose of this study is to evaluate the safety and persistence 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 therapy. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2019to May 2021
- 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) measurable disease at screening as defined by any of the following: serum monoclonal paraprotein (M-protein) level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours; or 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. Light chain MM without measurable disease in the serum or the urine is a specific definition in this study, which refers to subjects whose M-protein in the serum and M-protein in the urine is undetectable; 2) received at least 2 standard regimens, determined as progressive disease (PD) by IMWG criteria; received at least 3 prior lines of treatment for MM, undergone at least 1 complete cycle of treatment for each line, unless PD was documented by IMWG criteria as the best response to the regimen; 3) received a proteasome inhibitor(PI) and an immunomodulatory therapy (IMiD); 4) documented disease progression during, or within 12 months of, most recent anti-myeloma therapy.
- 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;
- Adequate organ function is defined as: 1) hemoglobin≥8.0g/dL(did not receive red blood cell transfusion ≤7 days prior to laboratory tests; recombinant human erythropoietin is allowed); 2) platelet count >50×10^9/L(did not receive blood transfusion ≤7 days prior to laboratory tests); 3) ANC ≥0.75×10^9/L(did not receive supportive treatment ≤7 days prior to laboratory tests; growth factors are allowed); 4) total bilirubin <2×ULN (for subjects with congenital hyperbilirubinemia such as Gilbert's syndrome, direct bilirubin≤1.5×ULN); 5) creatinine clearance (according to MDRD formulas or 24h urine collection result) ≥40 mL/min/1.73m^2; 6) ALT and AST <3×ULN; 7) corrected serum calcium ≤12.5 mg/dL (≤3.1 mmol/L), or free calcium ion ≤6.5 mg/dL(≤1.6 mmol/L); 8) oxygen saturation >92% on non-oxygen-assistance state;
- Females of childbearing potential must have a negative serum hypersensitive β-human chorionic gonadotropin (β-hCG) or urine pregnancy test result, at screening, and prior to lymphodepletion;
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- Females of childbearing potential must agree to use a highly effective contraception continuously from signing informed consent form until ≥100 days after CAR-T infusion (when continuously correctly used, failure rate <1% per year). Highly effective contraception include, user-independent method: 1) implantable progesterone contraceptives which can inhibit ovulation; 2) intrauterine device (IUD); Intrauterine hormone release system; 3) partner has a vasectomy; user-dependent method: 1) compound hormone contraceptives which can inhibit ovulation (contain estrogen and progesterone, oral/vaginal/transdermal administration); 2) progesterone contraceptives which can inhibit ovulation (oral administration or injection);
- Except for highly effective contraception, males must agree to use barrier contraception (such as condom plus spermicidal foam/gel/film/suppository) during sexual contact with a female of childbearing potential, to use condom during sexual contact with a pregnant female, from signing informed consent form until ≥100 days after CAR-T infusion; females and males must agree to avoid ovum/oocyte/sperm donation, during the study period and ≥100 days after CAR-T infusion. Note: hormone contraceptives may interact with the study treatment, thus reducing the contraceptive effect;
- Subject must sign an inform consent form indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study. Consent is to be obtained prior to the initiation of any study-related tests or procedures that are not part of standard-of-care for the subject's disease;
- Willing and able to adhere to the prohibitions and restrictions specified in this protocol.
Who cannot join
- History of CAR-T treatment, the target of CAR-T is not limited;
- History of anti-CD19 or anti-BCMA treatment;
- Concomitant invasive malignancy other than diagnosis or treatment of other radically-cured malignancies without malignant change ≥3 years prior to enrollment or adequately- treated non-melanoma skin cancer without malignant change evidence;
- Received targeted therapy, epigenetic therapy, experimental drug therapy, or experimental invasive medical device <14 days or 5 half-lives (according to the shorter one) prior to leukapheresis; received monoclonal antibody <21 days prior to leukapheresis; received cytotoxic chemotherapy, PI, radiotherapy <14 days prior to leukapheresis (for radiotherapy, if the radiation field is no more than 5% of bone marrow reserve, whenever radiotherapy ended, the subject is allowed to participate in the study); received IMiD <7 days prior to leukapheresis;
- Toxicities related to prior therapy did not relieve to baseline or ≤ grade 1, except for peripheral neuropathy and alopecia;
- The following cardiac conditions: New York Heart Association(NYHA) grade III or IV congestive heart failure; myocardial infarction or coronary artery bypass graft (CABG) ≤6 months prior to enrollment; history of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration; history of severe non-ischemic cardiomyopathy; impaired cardiac function (LVEF <45%) as assessed by echocardiogram or multiple-gated acquisition (MUGA) scan (performed ≤ 8 weeks prior to leukapheresis);
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- Systemic or local corticosteroid therapy of greater than 5 mg/day of prednisone (or equivalent dose of another corticosteroid) within 2 weeks prior to leukapheresis;
- Received either of the following: an allogeneic stem cell transplant for MM; an autologous stem cell transplant ≤ 12 weeks prior to leukapheresis;
- Known active central nervous system (CNS) involvement or emergence of meninges involvement clinical signs;
- Stroke or convulsions ≤ 6 months prior to ICF signing;
- Presence of plasma cell leukemia(plasma cell >2.0×10^9/L), Waldenstrom's macroglobulinemia, POEMS syndrome(polyneuropathy, organomegaly, endocrinopathy, monoclonal protein disease, skin changes) or primary amyloidosis(AL) at screening;
- Seropositive for human immunodeficiency virus (HIV); Hepatitis B infection as defined according to the American Society of Clinical Oncology (ASCO) guidelines. In the event the infection status is unclear, quantitative levels are necessary to determine the infection status. Hepatitis C (anti-hepatitis C virus [HCV] antibody positive or HCV-RNA quantitation positive) or known to have a history of hepatitis C;
- Attenuated live vaccine ≤4 weeks prior to enrollment;
- Known life threatening allergies, hypersensitivity, or intolerance to CAR-T cells or its ingredients, including dimethylsulfoxide;
- Serious underlying medical condition, such as: evidence of serious active viral, bacterial, or uncontrolled systemic fungal infection; active autoimmune disease or a history of autoimmune disease within 3 years; overt clinical evidence of dementia or altered mental status; hereditary bleeding/ coagulating disease, a history of non-traumatic bleeding or thromboembolism, other disease that may increase bleeding risk;
- Presence of any problems that may be detrimental to the subjects' receiving/tolerating planned treatment and the subject's understanding ICF; presence of any condition that the investigators think it is inappropriate for the subject to anticipate the trial (such as damaging health); presence of any condition that may deter, limit, or obfuscate protocol-defined evaluation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First affiliated hospital of air force military medical university(i.e., Xijing Hopital)
Xi’an, Shanxi, 710000
Xiequn Chen, Doctor, 84771857, xiequnchen@fmmu.end.cn
About this study
Official title: A Study of B-cell Maturation Antigen/Cluster of Differentiation Antigen 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 purpose of this study is to evaluate the safety and persistence 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 therapy.
- Conditions
- Multiple Myeloma
- Being tested
- BCMA/CD19 Dual-Target CAR-T
- 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-TBiological
BCMA/CD19 Dual-Target CAR-T target both BCMA and CD19. The subjects will receive CAR-T as one dose. The dosage ranges from 5×10^4 to 3×10^5 CAR+T/Kg.
| Study group | Role | What they receive |
|---|---|---|
| CAR-T treatment group | Experimental | The patients will receive one dose of BCMA/CD19 dual-target CAR-T. BCMA/CD19 dual-target CAR-T dosage ranges from 5×10^4 to 3×10^5 CAR+T/Kg. Receives: Biological: BCMA/CD19 Dual-Target CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of treatment related AE
Adverse events(AEs) will be collected and graded according to ASTCT consensus(for Cytokine Release Syndrome, CRS and Immune Effector Cell-Associated Neurotoxicity Syndrome, ICANS) and CTCAE v5.0(for AE except CRS/ICANS ).
Measured: 2 years
Incidence of DLT
Dose-limiting toxicity (DLT) will be collected. DLT refers to toxicity that limit the process to continue increasing CAR-T dose.
Measured: 12 weeks
CAR copies concentration in peripheral blood
CAR copies in peripheral blood will be measured by qPCR and FCM.
Measured: 2 years
Secondary outcomes (4)
ORR
Objective response rate (ORR) will be calculated. ORR refers to the proportion between the number of subjects who are evaluated as PR or status better than PR and total number of subjects.
Measured: 2 years
DOR
Duration of response (DOR) will be calculated. DOR refers to the time between the initial response (CR or PR) to therapy and evaluated as PD for the first time or death due to any reason.
Measured: 2 years
PFS Rate
Progression free survival (PFS) rate will be calculated. PFS refers to the proportion between the number of subjects who are evaluated as PD or died and total number of subjects.
Measured: 2 years
OS Rate
Overall survival (OS) rate will be calculated. OS refers to the proportion between the number of subjects who died and total number of subjects.
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 Dec 2019
- Study start15 Oct 2019
- Primary completionSep 2020 (estimated)
- Study completionMay 2021 (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.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- 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
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Gracell Biotechnology Ltd.
- Responsible party
- Sponsor
- Investigators
- Xiequn Chen, Doctor, Principal investigator, First affiliated hospital of air force military medical university(i.e., Xijing Hopital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04182581
- Sponsor's protocol ID
- PGC0008
- Status last verified
- Oct 2019
- First submitted
- 27 Nov 2019
- Last updated
- 2 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2019. 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 Antigen 19 Dual-Target Chimeric Antigen Receptor T Cell Immunotherapy for Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT04182581
- Acronym / sponsor ID
- PGC0008
- Conditions
- Multiple Myeloma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Collaborators
- Gracell Biotechnology Ltd.
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 2 Dec 2019 (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 purpose of this study is to evaluate the safety and persistence 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 therapy.
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-TThe patients will receive one dose of BCMA/CD19 dual-target CAR-T. BCMA/CD19 dual-target CAR-T dosage ranges from 5×10^4 to 3×10^5 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) measurable disease at screening as defined by any of the following: serum monoclonal paraprotein (M-protein) level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours; or 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. Light chain MM without measurable disease in the serum or the urine is a specific definition in this study, which refers to subjects whose M-protein in the serum and M-protein in the urine is undetectable; 2) received at least 2 standard regimens, determined as progressive disease (PD) by IMWG criteria; received at least 3 prior lines of treatment for MM, undergone at least 1 complete cycle of treatment for each line, unless PD was documented by IMWG criteria as the best response to the regimen; 3) received a proteasome inhibitor(PI) and an immunomodulatory therapy (IMiD); 4) documented disease progression during, or within 12 months of, most recent anti-myeloma therapy.
- 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;
- Adequate organ function is defined as: 1) hemoglobin≥8.0g/dL(did not receive red blood cell transfusion ≤7 days prior to laboratory tests; recombinant human erythropoietin is allowed); 2) platelet count >50×10^9/L(did not receive blood transfusion ≤7 days prior to laboratory tests); 3) ANC ≥0.75×10^9/L(did not receive supportive treatment ≤7 days prior to laboratory tests; growth factors are allowed); 4) total bilirubin <2×ULN (for subjects with congenital hyperbilirubinemia such as Gilbert's syndrome, direct bilirubin≤1.5×ULN); 5) creatinine clearance (according to MDRD formulas or 24h urine collection result) ≥40 mL/min/1.73m^2; 6) ALT and AST <3×ULN; 7) corrected serum calcium ≤12.5 mg/dL (≤3.1 mmol/L), or free calcium ion ≤6.5 mg/dL(≤1.6 mmol/L); 8) oxygen saturation >92% on non-oxygen-assistance state;
Key exclusion criteria (16 listed)
- History of CAR-T treatment, the target of CAR-T is not limited;
- History of anti-CD19 or anti-BCMA treatment;
- Concomitant invasive malignancy other than diagnosis or treatment of other radically-cured malignancies without malignant change ≥3 years prior to enrollment or adequately- treated non-melanoma skin cancer without malignant change evidence;
- Received targeted therapy, epigenetic therapy, experimental drug therapy, or experimental invasive medical device <14 days or 5 half-lives (according to the shorter one) prior to leukapheresis; received monoclonal antibody <21 days prior to leukapheresis; received cytotoxic chemotherapy, PI, radiotherapy <14 days prior to leukapheresis (for radiotherapy, if the radiation field is no more than 5% of bone marrow reserve, whenever radiotherapy ended, the subject is allowed to participate in the study); received IMiD <7 days prior to leukapheresis;
- Toxicities related to prior therapy did not relieve to baseline or ≤ grade 1, except for peripheral neuropathy and alopecia;
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-TBCMA/CD19 Dual-Target CAR-T target both BCMA and CD19. The subjects will receive CAR-T as one dose. The dosage ranges from 5×10^4 to 3×10^5 CAR+T/Kg. | Biological | CAR-T treatment group |
Primary outcome
Incidence and severity of treatment related AE
Time frame: 2 years
Adverse events(AEs) will be collected and graded according to ASTCT consensus(for Cytokine Release Syndrome, CRS and Immune Effector Cell-Associated Neurotoxicity Syndrome, ICANS) and CTCAE v5.0(for AE except CRS/ICANS ).
Incidence of DLT
Time frame: 12 weeks
Dose-limiting toxicity (DLT) will be collected. DLT refers to toxicity that limit the process to continue increasing CAR-T dose.
CAR copies concentration in peripheral blood
Time frame: 2 years
CAR copies in peripheral blood will be measured by qPCR and FCM.
4 secondary outcomes
ORR
Time frame: 2 years
DOR
Time frame: 2 years
PFS Rate
Time frame: 2 years
OS 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 2 Dec 2019.
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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.
Xiequn Chen, Doctor principal investigator
First affiliated hospital of air force military medical university(i.e., Xijing Hopital)
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 in people with Multiple Myeloma, run by Xijing 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 16 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 Dec 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 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 Xiequn Chen, Doctor (84771857, xiequnchen@fmmu.end.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of treatment related AE (time frame: 2 years). The study lists 3 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 2 Dec 2019; AzTrials last refreshed its copy on 6 Nov 2026.