Multiple Myeloma in RelapsePhase 1NCT03706547
Anti-CD19/BCMA Bispecific CAR-T Cell Therapy for R/R MM
A Phase 1 study testing anti-CD19/BCMA CAR-T cells, Fludarabine and Cyclophosphamide in people with Multiple Myeloma in Relapse and Multiple Myeloma Progression, run by Peng Liu at 1 site in China.
Trial summary
The goal of this clinical trial is to study the feasibility and efficacy of anti-CD19/BCMA bispecific chimeric antigen receptors (CARs) T cell therapy for relapsed and refractory 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 Progression
- What is being tested?
- anti-CD19/BCMA CAR-T cells, Fludarabine and Cyclophosphamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2018to Dec 2021
- Phase
- 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
- Expected survival > 12 weeks
- Diagnosis of Multiple Myeloma by IMWG updated criteria (2014)
- Pathology demonstrated that BCMA-poitive malignant plasma cells exited in bone marrow or plamacytoma
- Exited measurable lesions and in accordance with one of the following test indicators: serum M protein≥1 g/dl; urine M protein≥200 mg/24h; serum free light chain≥10 mg/dl; diagnosis of plasmacytoma by biopsy
- The criteria for relapsed and refractory multiple myeloma: patients previously received at least 3 different prior treatment regimens for multiple myeloma, including protein inhibitors (eg: Bortezomib), and immunomodulator (eg: Revlimid), and have disease progression in the past 60 days
- At least 90 days after stem cell transplantation
Show all 14Show fewer
- Clinical performance status of ECOG score 0-2
- Creatinine≤2.0 mg/dl
- Bilirubin≤2.0 mg/dl
- The ALT/AST value is lower than 2.5-fold of normal value
- Accessible to intravenous injection, and no white blood cell collection contraindications
- Sexually active patients must be willing to utilize one of the more effective birth control methods for 30 days after the CTL infusion. Male partner should use a condom
- 5mg/day dose of Prednisone or other equivalent steroid hormone drugs (eg: Dexamethasone) were not used for two weeks before apheresis and CAR-T infusion
- Able to understand and sign the Informed Consent Document.
Who cannot join
- Patients with symptoms of central nervous system
- Patients with second malignancies in addition to multiple myeloma
- Active hepatitis B or C, HIV infections
- Any other active diseases could affect the enrollment of this trial
- Long term use of immunosuppressive agents after organ transplantation, except currently receiving or recently received glucocorticoid treatment
- Patients with organ failure
Show all 11Show fewer
- Women of child-bearing potential who are pregnant or breastfeeding during therapy, or have a planned pregnancy with 2 months after therapy
- A history of mental illness and poorly controlled
- Women of child-bearing potential who are not willing to practice birth control from the time of enrollment on this study and for 2 months after receiving the preparative regimen. Women of child bearing potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion
- Patients who are accounted by researchers to be not appropriate for this test
- Subjects suffering disease affects the understanding of informed consent or complying with study protocol
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Hematology ,Fudan University Zhongshan Hospital
Shanghai, 200032
About this study
Official title: Clinical Study of Anti-CD19/BCMA Bispecific Chimeric Antigen Receptors (CARs) T Cell Therapy for Relapsed and Refractory Multiple Myeloma
The goal of this clinical trial is to study the feasibility and efficacy of anti-CD19/BCMA bispecific chimeric antigen receptors (CARs) T cell therapy for relapsed and refractory multiple myeloma.
Read the detailed description
Primary Objectives
- To determine the feasibility ad safety of anti-CD19/BCMA CAR-T cells in treating patients with BCMA-positive multiple myeloma.
Secondary Objectives
- To access the efficacy of anti-CD19/BCMA CAR-T cells in patients with multiple myeloma.
- To determine in vivo dynamics and persistency of anti-CD19/BCMA CAR-T cells.
- Being tested
- anti-CD19/BCMA CAR-T cells, Fludarabine, Cyclophosphamide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-CD19/BCMA CAR-T cellsBiological
Retroviral vector-transduced autologous T cells to express anti-CD19 and anti-BCMA CARs
FludarabineDrug
30mg/m2/d
CyclophosphamideDrug
300mg/m2/d
| Study group | Role | What they receive |
|---|---|---|
| anti-CD19/BCMA CAR-T cells | Experimental | 1. Chemotherapy with a classic combination with fludarabine and cyclophosphamide;
2. Administration with anti-CD19/BCMA CAR-T cells in the BCMA-positive multiple myeloma patients. Receives: Biological: anti-CD19/BCMA CAR-T cells; Drug: Fludarabine; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0
Measured: 6 months
Secondary outcomes (2)
Overall remission rate defined by the standard response criteria for myeloma for each arm
Overall remission rate defined by the standard response criteria for myeloma for each arm
Measured: 8 weeks
Duration of CAR-positive T cells in circulation
Duration of CAR-positive T cells in circulation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2018
- Study start30 Oct 2018 (estimated)
- Primary completionJul 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peng Liu
- Sponsor type
- University, hospital or other
- Collaborators
- Hrain Biotechnology, Shanghai East Hospital
- Responsible party
- Sponsor-investigator, Peng Liu, Shanghai Zhongshan Hospital
- Investigators
- Peng Liu, M.D. & Ph.D., Principal investigator, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03706547
- Sponsor's protocol ID
- SHZS-MM002
- Status last verified
- Oct 2018
- First submitted
- 11 Oct 2018
- Last updated
- 16 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Siegel RL, Miller KD, Jemal A. Cancer statistics, 2018. CA Cancer J Clin. 2018 Jan;68(1):7-30. doi: 10.3322/caac.21442. Epub 2018 Jan 4.
PubMed 29313949Child JA, Morgan GJ, Davies FE, Owen RG, Bell SE, Hawkins K, Brown J, Drayson MT, Selby PJ; Medical Research Council Adult Leukaemia Working Party. High-dose chemotherapy with hematopoietic stem-cell rescue for multiple myeloma. N Engl J Med. 2003 May 8;348(19):1875-83. doi: 10.1056/NEJMoa022340.
PubMed 12736280Hari PN, McCarthy PL. Multiple myeloma: future directions in autologous transplantation and novel agents. Biol Blood Marrow Transplant. 2013 Jan;19(1 Suppl):S20-5. doi: 10.1016/j.bbmt.2012.11.002. No abstract available.
PubMed 23290439Bruno B, Rotta M, Patriarca F, Mordini N, Allione B, Carnevale-Schianca F, Giaccone L, Sorasio R, Omede P, Baldi I, Bringhen S, Massaia M, Aglietta M, Levis A, Gallamini A, Fanin R, Palumbo A, Storb R, Ciccone G, Boccadoro M. A comparison of allografting with autografting for newly diagnosed myeloma. N Engl J Med. 2007 Mar 15;356(11):1110-20. doi: 10.1056/NEJMoa065464.
PubMed 17360989Hideshima T, Podar K, Chauhan D, Ishitsuka K, Mitsiades C, Tai YT, Hamasaki M, Raje N, Hideshima H, Schreiner G, Nguyen AN, Navas T, Munshi NC, Richardson PG, Higgins LS, Anderson KC. p38 MAPK inhibition enhances PS-341 (bortezomib)-induced cytotoxicity against multiple myeloma cells. Oncogene. 2004 Nov 18;23(54):8766-76. doi: 10.1038/sj.onc.1208118.
PubMed 15480425Shringarpure R, Catley L, Bhole D, Burger R, Podar K, Tai YT, Kessler B, Galardy P, Ploegh H, Tassone P, Hideshima T, Mitsiades C, Munshi NC, Chauhan D, Anderson KC. Gene expression analysis of B-lymphoma cells resistant and sensitive to bortezomib. Br J Haematol. 2006 Jul;134(2):145-56. doi: 10.1111/j.1365-2141.2006.06132.x.
PubMed 16846475Godfrey J, Benson DM Jr. The role of natural killer cells in immunity against multiple myeloma. Leuk Lymphoma. 2012 Sep;53(9):1666-76. doi: 10.3109/10428194.2012.676175. Epub 2012 Apr 19.
PubMed 22423650Lawrence T, Natoli G. Transcriptional regulation of macrophage polarization: enabling diversity with identity. Nat Rev Immunol. 2011 Oct 25;11(11):750-61. doi: 10.1038/nri3088.
PubMed 22025054Ratta M, Fagnoni F, Curti A, Vescovini R, Sansoni P, Oliviero B, Fogli M, Ferri E, Della Cuna GR, Tura S, Baccarani M, Lemoli RM. Dendritic cells are functionally defective in multiple myeloma: the role of interleukin-6. Blood. 2002 Jul 1;100(1):230-7. doi: 10.1182/blood.v100.1.230.
PubMed 12070032Favaloro J, Brown R, Aklilu E, Yang S, Suen H, Hart D, Fromm P, Gibson J, Khoo L, Ho PJ, Joshua D. Myeloma skews regulatory T and pro-inflammatory T helper 17 cell balance in favor of a suppressive state. Leuk Lymphoma. 2014 May;55(5):1090-8. doi: 10.3109/10428194.2013.825905. Epub 2013 Aug 28.
PubMed 23865833Rosenberg SA, Restifo NP. Adoptive cell transfer as personalized immunotherapy for human cancer. Science. 2015 Apr 3;348(6230):62-8. doi: 10.1126/science.aaa4967.
PubMed 25838374Garfall AL, Maus MV, Hwang WT, Lacey SF, Mahnke YD, Melenhorst JJ, Zheng Z, Vogl DT, Cohen AD, Weiss BM, Dengel K, Kerr ND, Bagg A, Levine BL, June CH, Stadtmauer EA. Chimeric Antigen Receptor T Cells against CD19 for Multiple Myeloma. N Engl J Med. 2015 Sep 10;373(11):1040-7. doi: 10.1056/NEJMoa1504542.
PubMed 26352815Casucci M, Nicolis di Robilant B, Falcone L, Camisa B, Norelli M, Genovese P, Gentner B, Gullotta F, Ponzoni M, Bernardi M, Marcatti M, Saudemont A, Bordignon C, Savoldo B, Ciceri F, Naldini L, Dotti G, Bonini C, Bondanza A. CD44v6-targeted T cells mediate potent antitumor effects against acute myeloid leukemia and multiple myeloma. Blood. 2013 Nov 14;122(20):3461-72. doi: 10.1182/blood-2013-04-493361. Epub 2013 Sep 9.
PubMed 24016461Shaffer DR, Savoldo B, Yi Z, Chow KK, Kakarla S, Spencer DM, Dotti G, Wu MF, Liu H, Kenney S, Gottschalk S. T cells redirected against CD70 for the immunotherapy of CD70-positive malignancies. Blood. 2011 Apr 21;117(16):4304-14. doi: 10.1182/blood-2010-04-278218. Epub 2011 Feb 8.
PubMed 21304103Drent E, Groen RW, Noort WA, Themeli M, Lammerts van Bueren JJ, Parren PW, Kuball J, Sebestyen Z, Yuan H, de Bruijn J, van de Donk NW, Martens AC, Lokhorst HM, Mutis T. Pre-clinical evaluation of CD38 chimeric antigen receptor engineered T cells for the treatment of multiple myeloma. Haematologica. 2016 May;101(5):616-25. doi: 10.3324/haematol.2015.137620. Epub 2016 Feb 8.
PubMed 26858358
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Anti-CD19/BCMA Bispecific Chimeric Antigen Receptors (CARs) T Cell Therapy for Relapsed and Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT03706547
- Acronym / sponsor ID
- SHZS-MM002
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Peng LiuUniversity, hospital or other
- Collaborators
- Hrain Biotechnology, Shanghai East Hospital
- Study start
- 30 Oct 2018 (estimated)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 16 Oct 2018 (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 goal of this clinical trial is to study the feasibility and efficacy of anti-CD19/BCMA bispecific chimeric antigen receptors (CARs) T cell therapy for relapsed and refractory multiple myeloma.
Detailed description
Primary Objectives
- To determine the feasibility ad safety of anti-CD19/BCMA CAR-T cells in treating patients with BCMA-positive multiple myeloma.
Secondary Objectives
- To access the efficacy of anti-CD19/BCMA CAR-T cells in patients with multiple myeloma.
- To determine in vivo dynamics and persistency of anti-CD19/BCMA CAR-T cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| anti-CD19/BCMA CAR-T cells | Experimental | Biological: anti-CD19/BCMA CAR-T cells, Drug: Fludarabine, Drug: Cyclophosphamide1. Chemotherapy with a classic combination with fludarabine and cyclophosphamide; 2. Administration with anti-CD19/BCMA CAR-T cells in the BCMA-positive multiple myeloma patients. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Expected survival > 12 weeks
- Diagnosis of Multiple Myeloma by IMWG updated criteria (2014)
- Pathology demonstrated that BCMA-poitive malignant plasma cells exited in bone marrow or plamacytoma
- Exited measurable lesions and in accordance with one of the following test indicators: serum M protein≥1 g/dl; urine M protein≥200 mg/24h; serum free light chain≥10 mg/dl; diagnosis of plasmacytoma by biopsy
- The criteria for relapsed and refractory multiple myeloma: patients previously received at least 3 different prior treatment regimens for multiple myeloma, including protein inhibitors (eg: Bortezomib), and immunomodulator (eg: Revlimid), and have disease progression in the past 60 days
Key exclusion criteria (11 listed)
- Patients with symptoms of central nervous system
- Patients with second malignancies in addition to multiple myeloma
- Active hepatitis B or C, HIV infections
- Any other active diseases could affect the enrollment of this trial
- Long term use of immunosuppressive agents after organ transplantation, except currently receiving or recently received glucocorticoid treatment
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 |
|---|---|---|
| anti-CD19/BCMA CAR-T cellsRetroviral vector-transduced autologous T cells to express anti-CD19 and anti-BCMA CARs | Biological | anti-CD19/BCMA CAR-T cells |
| Fludarabine30mg/m2/d | Drug | anti-CD19/BCMA CAR-T cells |
| Cyclophosphamide300mg/m2/d | Drug | anti-CD19/BCMA CAR-T cells |
Primary outcome
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0
Time frame: 6 months
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0
2 secondary outcomes
Overall remission rate defined by the standard response criteria for myeloma for each arm
Time frame: 8 weeks
Duration of CAR-positive T cells in circulation
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
- Background: PubMed 29313949Siegel RL, Miller KD, Jemal A. Cancer statistics, 2018. CA Cancer J Clin. 2018 Jan;68(1):7-30. doi: 10.3322/caac.21442. Epub 2018 Jan 4.
- Background: PubMed 12736280Child JA, Morgan GJ, Davies FE, Owen RG, Bell SE, Hawkins K, Brown J, Drayson MT, Selby PJ; Medical Research Council Adult Leukaemia Working Party. High-dose chemotherapy with hematopoietic stem-cell rescue for multiple myeloma. N Engl J Med. 2003 May 8;348(19):1875-83. doi: 10.1056/NEJMoa022340.
- Background: PubMed 23290439Hari PN, McCarthy PL. Multiple myeloma: future directions in autologous transplantation and novel agents. Biol Blood Marrow Transplant. 2013 Jan;19(1 Suppl):S20-5. doi: 10.1016/j.bbmt.2012.11.002. No abstract available.
- Background: PubMed 17360989Bruno B, Rotta M, Patriarca F, Mordini N, Allione B, Carnevale-Schianca F, Giaccone L, Sorasio R, Omede P, Baldi I, Bringhen S, Massaia M, Aglietta M, Levis A, Gallamini A, Fanin R, Palumbo A, Storb R, Ciccone G, Boccadoro M. A comparison of allografting with autografting for newly diagnosed myeloma. N Engl J Med. 2007 Mar 15;356(11):1110-20. doi: 10.1056/NEJMoa065464.
- Background: PubMed 15480425Hideshima T, Podar K, Chauhan D, Ishitsuka K, Mitsiades C, Tai YT, Hamasaki M, Raje N, Hideshima H, Schreiner G, Nguyen AN, Navas T, Munshi NC, Richardson PG, Higgins LS, Anderson KC. p38 MAPK inhibition enhances PS-341 (bortezomib)-induced cytotoxicity against multiple myeloma cells. Oncogene. 2004 Nov 18;23(54):8766-76. doi: 10.1038/sj.onc.1208118.
- Background: PubMed 16846475Shringarpure R, Catley L, Bhole D, Burger R, Podar K, Tai YT, Kessler B, Galardy P, Ploegh H, Tassone P, Hideshima T, Mitsiades C, Munshi NC, Chauhan D, Anderson KC. Gene expression analysis of B-lymphoma cells resistant and sensitive to bortezomib. Br J Haematol. 2006 Jul;134(2):145-56. doi: 10.1111/j.1365-2141.2006.06132.x.
- Background: PubMed 22423650Godfrey J, Benson DM Jr. The role of natural killer cells in immunity against multiple myeloma. Leuk Lymphoma. 2012 Sep;53(9):1666-76. doi: 10.3109/10428194.2012.676175. Epub 2012 Apr 19.
- Background: PubMed 22025054Lawrence T, Natoli G. Transcriptional regulation of macrophage polarization: enabling diversity with identity. Nat Rev Immunol. 2011 Oct 25;11(11):750-61. doi: 10.1038/nri3088.
- Background: PubMed 12070032Ratta M, Fagnoni F, Curti A, Vescovini R, Sansoni P, Oliviero B, Fogli M, Ferri E, Della Cuna GR, Tura S, Baccarani M, Lemoli RM. Dendritic cells are functionally defective in multiple myeloma: the role of interleukin-6. Blood. 2002 Jul 1;100(1):230-7. doi: 10.1182/blood.v100.1.230.
- Background: PubMed 23865833Favaloro J, Brown R, Aklilu E, Yang S, Suen H, Hart D, Fromm P, Gibson J, Khoo L, Ho PJ, Joshua D. Myeloma skews regulatory T and pro-inflammatory T helper 17 cell balance in favor of a suppressive state. Leuk Lymphoma. 2014 May;55(5):1090-8. doi: 10.3109/10428194.2013.825905. Epub 2013 Aug 28.
- Background: PubMed 25838374Rosenberg SA, Restifo NP. Adoptive cell transfer as personalized immunotherapy for human cancer. Science. 2015 Apr 3;348(6230):62-8. doi: 10.1126/science.aaa4967.
- Background: PubMed 26352815Garfall AL, Maus MV, Hwang WT, Lacey SF, Mahnke YD, Melenhorst JJ, Zheng Z, Vogl DT, Cohen AD, Weiss BM, Dengel K, Kerr ND, Bagg A, Levine BL, June CH, Stadtmauer EA. Chimeric Antigen Receptor T Cells against CD19 for Multiple Myeloma. N Engl J Med. 2015 Sep 10;373(11):1040-7. doi: 10.1056/NEJMoa1504542.
- Individual participant dataSharing planned: Undecided
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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.
Peng Liu, M.D. & Ph.D. principal investigator
Shanghai Zhongshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing anti-CD19/BCMA CAR-T cells, Fludarabine and Cyclophosphamide in people with Multiple Myeloma in Relapse and Multiple Myeloma Progression, run by Peng Liu 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 14 inclusion and 11 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 16 Oct 2018. 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?
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.
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 Zheng Wei, M.D. (+(86)-21 64041990 ext. 2925, wei.zheng@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0 (time frame: 6 months). 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 NCT03706547, which also lists 30 linked publications.
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 16 Oct 2018.