Multiple MyelomaPhase 1/2NCT03196414
Study of T Cells Targeting CD138/BCMA/CD19/More Antigens (CART-138/BCMA/19/More) for Chemotherapy Refractory and Relapsed Multiple Myeloma
A Phase 1/2 study testing CART-138/BCMA/19/more in people with Multiple Myeloma, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
Placing a tumor antigen chimeric receptor that has been created in the laboratory into patient autologous or donor-derived T cells may make the body build immune response to kill cancer cells. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- CART-138/BCMA/19/more
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- Sep 2016to Dec 2026
- Phase
- Phase 1/2
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- CD138 or BCMA antigen positive multiple myeloma in patients with no available curative treatment options (such as autologous or allogeneic SCT).
- Relapsed and/or refractory multiple myeloma.
- Relapsed after prior autologous or allogenic SCT.
- Expected survival ≥ 3 months
- Creatinine < 2.0 mg/dl
- Blood coagulation function: PT and APTT < 2x normal
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- Arterial blood oxygen saturation > 92%
- Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) < 3x normal
- Karnofsky scores ≥ 60 and ECOG score ≤ 2
- Adequate venous access for apheresis, and no other contraindications for leukapheresis
- Patients should not take system chemotherapy in one month and immunotherapy in three months prior to CART cells infusion.
- Voluntary informed consent is given
Who cannot join
- Pregnant or lactating women
- Uncontrolled active infection.
- Active hepatitis B or hepatitis C infection.
- Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
- Previously treatment with any gene therapy products
- Any uncontrolled active medical disorder that would preclude participation as outlined.
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- HIV infection.
- History of myocardial infarction and severe arrhythmia in half a year
- Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).
- Patients with fever of unknown origin (T > 38℃)
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
First Affiliated Hospital, Soochow University
Suzhou, Jiangsu, 215000
Ling zhi Yan, Phd, 13584821140, yanlingzhi@suda.edu.cn
About this study
Placing a tumor antigen chimeric receptor that has been created in the laboratory into patient autologous or donor-derived T cells may make the body build immune response to kill cancer cells. Genetically engineered lymphocyte (CART) therapy has showed good safety and efficacy in treatment of lymphoma and acute lymphoblastic leukemia. Researchers want to see if this helps people with multiple myeloma.To test the safety and efficacy of giving targeting CD138 or B-cell maturation antigen or CD19 or more antigens T cells in treating patients with multiple myeloma that is refractory to further chemotherapy or relapsed(after stem cell transplantation or intensive chemotherapy).
Read the detailed description
Adults ages 18-75 with Relapsed and/or Chemotherapy Refractory Multiple Myelomas.
Design:
Participants may be screened with:
Medical history Physical exam Blood and urine tests Heart tests Bone marrow sample Multiple scans and X-rays Lymphocytes are collected by apheresis from the enrolled patient or a healthy donor. Blood is removed through a needle in an arm. The rest of the blood is returned through a needle in the other arm.
The cells will be changed in a laboratory. Participants will get 2 chemotherapy drugs over 5 days. Two days later, participants will get an intravenous (IV) catheter in an arm. They will get the split doses CART cells on day0, day1, day2 through the IV in 1 infusion.
After this, participants will stay in the hospital for at least 9 days and stay nearby for 2 weeks. Then they will have blood tests and see a doctor.
Participants will visit the clinic at 1, 2, 3, 6, 9 and 12 months after the infusion, then every 6 months until two years after infusion. A bone marrow sample will be taken at the 3-month visit.
- Conditions
- Multiple Myeloma
- Being tested
- CART-138/BCMA/19/more
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CART-138/BCMA/19/moreBiological
Cyclophosphamide，Fludarabine，CART-138/BCMA /19/more cells Cyclophosphamide: 300 mg/m2 IV over 30 minutes on days -5 , -4,and -3; Fludarabine: 30 mg/m2 IV over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3 Biological: Anti-CD138/BCMA/CD19/more total CART cells 5x106- 100x106 CAR+ T cells per kg of recipient bodyweight
| Study group | Role | What they receive |
|---|---|---|
| CART-138/BCMA/19/more | Experimental | Not described Receives: Biological: CART-138/BCMA/19/more |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine if there is grade 3 to 5 cytokine release syndrome
Number of Patients With Grade 3 Through Grade 5 Cytokine Release Syndrome(CRS) That Are Related to Study Intervening Measures, Graded According to NCI CTCAE Version 4.0
Measured: 2 weeks-12 months after initial dose
Secondary outcomes (1)
Investigators try to assess major reaction rate (MRR, PR+VGPR+CR) at the end of the research.
Number of Patients achieved major reaction rate (MRR;PR+VGPR+CR) According to IMWG response criteria at the end of the research.
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study startSep 2016
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe 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
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fu cheng cheng, PhD, Principal investigator, First Affiliated Hospital,Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03196414
- Sponsor's protocol ID
- myeloma-01
- Status last verified
- Sep 2016
- First submitted
- 19 Oct 2016
- Last updated
- 2 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Zhang Y, Zhang C, Zhou J, Zhang J, Chen X, Chen J, Wang P, Sun X, Lou X, Qi W, Kang L, Yu L, Wu D, Li C. Case Report: Reversible Neurotoxicity and a Clinical Response Induced by BCMA-Directed Chimeric Antigen Receptor T Cells Against Multiple Myeloma With Central Nervous System Involvement. Front Immunol. 2021 Feb 25;12:552429. doi: 10.3389/fimmu.2021.552429. eCollection 2021.
PubMed 33717057
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of T Cells Targeting CD138/BCMA/CD19/More Antigens (CART-138/BCMA/19/More) for Chemotherapy Refractory and Relapsed Multiple Myeloma
- ClinicalTrials.gov ID
- NCT03196414
- Acronym / sponsor ID
- myeloma-01
- Conditions
- Multiple Myeloma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Jun 2017 (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.
Placing a tumor antigen chimeric receptor that has been created in the laboratory into patient autologous or donor-derived T cells may make the body build immune response to kill cancer cells. Genetically engineered lymphocyte (CART) therapy has showed good safety and efficacy in treatment of lymphoma and acute lymphoblastic leukemia. Researchers want to see if this helps people with multiple myeloma.To test the safety and efficacy of giving targeting CD138 or B-cell maturation antigen or CD19 or more antigens T cells in treating patients with multiple myeloma that is refractory to further chemotherapy or relapsed(after stem cell transplantation or intensive chemotherapy).
Detailed description
Adults ages 18-75 with Relapsed and/or Chemotherapy Refractory Multiple Myelomas.
Design:
Participants may be screened with:
Medical history Physical exam Blood and urine tests Heart tests Bone marrow sample Multiple scans and X-rays Lymphocytes are collected by apheresis from the enrolled patient or a healthy donor. Blood is removed through a needle in an arm. The rest of the blood is returned through a needle in the other arm.
The cells will be changed in a laboratory. Participants will get 2 chemotherapy drugs over 5 days. Two days later, participants will get an intravenous (IV) catheter in an arm. They will get the split doses CART cells on day0, day1, day2 through the IV in 1 infusion.
After this, participants will stay in the hospital for at least 9 days and stay nearby for 2 weeks. Then they will have blood tests and see a doctor.
Participants will visit the clinic at 1, 2, 3, 6, 9 and 12 months after the infusion, then every 6 months until two years after infusion. A bone marrow sample will be taken at the 3-month visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CART-138/BCMA/19/more | Experimental | Biological: CART-138/BCMA/19/more |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- CD138 or BCMA antigen positive multiple myeloma in patients with no available curative treatment options (such as autologous or allogeneic SCT).
- Relapsed and/or refractory multiple myeloma.
- Relapsed after prior autologous or allogenic SCT.
- Expected survival ≥ 3 months
- Creatinine < 2.0 mg/dl
Key exclusion criteria (10 listed)
- Pregnant or lactating women
- Uncontrolled active infection.
- Active hepatitis B or hepatitis C infection.
- Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
- Previously treatment with any gene therapy products
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 |
|---|---|---|
| CART-138/BCMA/19/moreCyclophosphamide，Fludarabine，CART-138/BCMA /19/more cells Cyclophosphamide: 300 mg/m2 IV over 30 minutes on days -5 , -4,and -3; Fludarabine: 30 mg/m2 IV over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3 Biological: Anti-CD138/BCMA/CD19/more total CART cells 5x106- 100x106 CAR+ T cells per kg of recipient bodyweight | Biological | CART-138/BCMA/19/more |
Primary outcome
Determine if there is grade 3 to 5 cytokine release syndrome
Time frame: 2 weeks-12 months after initial dose
Number of Patients With Grade 3 Through Grade 5 Cytokine Release Syndrome(CRS) That Are Related to Study Intervening Measures, Graded According to NCI CTCAE Version 4.0
1 secondary outcome
Investigators try to assess major reaction rate (MRR, PR+VGPR+CR) at the end of the research.
Time frame: up to 24 weeks
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 2 May 2019.
- Derived from this study: PubMed 33717057Zhang Y, Zhang C, Zhou J, Zhang J, Chen X, Chen J, Wang P, Sun X, Lou X, Qi W, Kang L, Yu L, Wu D, Li C. Case Report: Reversible Neurotoxicity and a Clinical Response Induced by BCMA-Directed Chimeric Antigen Receptor T Cells Against Multiple Myeloma With Central Nervous System Involvement. Front Immunol. 2021 Feb 25;12:552429. doi: 10.3389/fimmu.2021.552429. eCollection 2021.
- 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.
Fu cheng cheng, PhD principal investigator
First Affiliated Hospital,Soochow University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CART-138/BCMA/19/more in people with Multiple Myeloma, run by The First Affiliated Hospital of Soochow 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 12 inclusion and 10 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 2 May 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Ling zhi Yan, PhD (13584821140, yanlingzhi@suda.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine if there is grade 3 to 5 cytokine release syndrome (time frame: 2 weeks-12 months after initial dose). 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 NCT03196414, which also lists 1 linked publication.
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 May 2019.