Multiple MyelomaPhase 1NCT02135406
CART-19 for Multiple Myeloma
A Phase 1 study testing CART-19 T cells in people with Multiple Myeloma, run by University of Pennsylvania at 1 site in United States.
Trial summary
The primary goals: determine the safety, tolerability and engraftment potential of CART-19 T cells in patients undergoing salvage ASCT after early relapse following first ASCT. CART-19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCR(zeta):41BB administered by intravenous infusion using a single… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- CART-19 T cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to 18 Jan 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Subjects must not:
- Be pregnant or lactating.
- Have inadequate venous access for or contraindications to leukapheresis.
- Have any active and uncontrolled infection.
- Have active or chronic hepatitis B [detectable hepatitis B surface antigen (HBsAg)], hepatitis C [positive serology (HCV Ab)], or HIV infection.
- Any uncontrolled medical disorder that would preclude participation as outlined.
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- Have undergone allogeneic stem cell transplantation.
- Have received prior gene therapy or gene-modified cellular immunotherapy. Subject may have received, however, non-gene-modified autologous T-cells with their first ASCT in association with an anti-myeloma vaccine (e.g., hTERT or MAGEA3) or vaccination against infectious agents (e.g., influenza or pneumococcus) as was performed on our previous studies.
- Have undergone two prior ASCTs if the second ASCT was a salvage ASCT (defined as a second ASCT performed upon progression following first ASCT) rather than a second ASCT as part of a tandem ASCT consolidation regimen.
- Have auto-immune disease (including connective tissue disease, uveitis, sarcoidosis, inflammatory bowel disease, or multiple sclerosis) that is active and severe in the judgment of the principal investigator, or have a history of autoimmune disease that has required prolonged immunosuppressive therapy in the judgment of the principal investigator.
- Have active central nervous system disease, including CNS involvement by malignancy or evidence of blood in the CNS such as subdural hematoma. If a subject has any neurological abnormality on examination, a baseline brain MRI is required to exclude structural disease and/or intracranial bleeding. Patients with clinically significant intracranial lesions should be excluded. Patients with common age-related changes that are not clinically significant (i.e. moderate small vessel ischemic changes) do not need to be excluded.
- Have a Class III/IV cardiovascular disability according to the New York Heart Association Classification
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Pilot Study Of Redirected Autologous T Cells Engineered To Contain Anti-CD19 Attached To TCRζ And 4-1BB Signaling Domains Coupled With Salvage Autologous Stem-Cell Transplantation (ASCT) In Multiple Myeloma Patients With Early Relapse/Progression After Initial ASCT
The primary goals: determine the safety, tolerability and engraftment potential of CART-19 T cells in patients undergoing salvage ASCT after early relapse following first ASCT. CART-19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCR(zeta):41BB administered by intravenous infusion using a single infusion of 1-5x108 CART19-transduced T cells on day +2 after autologous stem cell infusion following high-dose melphalan.
- Conditions
- Multiple Myeloma
- Being tested
- CART-19 T cells
- Keywords
- Adult, 18 years or older, multiple myeloma, poor prognosis, relapsed/progressive disease, within one year of first autologous stem cell transplantation
- Medical subject headings
- Multiple Myeloma, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CART-19 T cellsBiological
| Study group | Role | What they receive |
|---|---|---|
| Multiple Myeloma Patients | Experimental | Adult subjects (18 years or older) with multiple myeloma and with poor prognosis by virtue of having relapsed/progressive disease within one year of first autologous stem cell transplantation. Receives: Biological: CART-19 T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events
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 posted12 May 2014 (estimated)
- Study startMay 2014
- Primary completionSep 2015
- Study completion18 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 University of PennsylvaniaThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edward Stadtmauer, MD, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02135406
- Sponsor's protocol ID
- UPCC02413, 817462
- Status last verified
- Feb 2018
- First submitted
- 8 May 2014
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Garfall AL, Stadtmauer EA, Hwang WT, Lacey SF, Melenhorst JJ, Krevvata M, Carroll MP, Matsui WH, Wang Q, Dhodapkar MV, Dhodapkar K, Das R, Vogl DT, Weiss BM, Cohen AD, Mangan PA, Ayers EC, Nunez-Cruz S, Kulikovskaya I, Davis MM, Lamontagne A, Dengel K, Kerr ND, Young RM, Siegel DL, Levine BL, Milone MC, Maus MV, June CH. Anti-CD19 CAR T cells with high-dose melphalan and autologous stem cell transplantation for refractory multiple myeloma. JCI Insight. 2018 Apr 19;3(8):e120505. doi: 10.1172/jci.insight.120505. eCollection 2018 Apr 19.
PubMed 29669947Garfall 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 26352815
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Of Redirected Autologous T Cells Engineered To Contain Anti-CD19 Attached To TCRζ And 4-1BB Signaling Domains Coupled With Salvage Autologous Stem-Cell Transplantation (ASCT) In Multiple Myeloma Patients With Early Relapse/Progression After Initial ASCT
- ClinicalTrials.gov ID
- NCT02135406
- Acronym / sponsor ID
- UPCC02413, 817462
- Conditions
- Multiple Myeloma
- Keywords
- Adult, 18 years or older, multiple myeloma, poor prognosis, relapsed/progressive disease, within one year of first autologous stem cell transplantation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- 18 Jan 2018 (actual)
- First posted
- 12 May 2014 (estimated)
- 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 primary goals: determine the safety, tolerability and engraftment potential of CART-19 T cells in patients undergoing salvage ASCT after early relapse following first ASCT. CART-19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCR(zeta):41BB administered by intravenous infusion using a single infusion of 1-5x108 CART19-transduced T cells on day +2 after autologous stem cell infusion following high-dose melphalan.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiple Myeloma Patients | Experimental | Biological: CART-19 T cellsAdult subjects (18 years or older) with multiple myeloma and with poor prognosis by virtue of having relapsed/progressive disease within one year of first autologous stem cell transplantation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (12 listed)
- Be pregnant or lactating.
- Have inadequate venous access for or contraindications to leukapheresis.
- Have any active and uncontrolled infection.
- Have active or chronic hepatitis B [detectable hepatitis B surface antigen (HBsAg)], hepatitis C [positive serology (HCV Ab)], or HIV infection.
- Any uncontrolled medical disorder that would preclude participation as outlined.
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-19 T cells | Biological | Multiple Myeloma Patients |
Primary outcome
Number of Adverse Events
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Derived from this study: PubMed 29669947Garfall AL, Stadtmauer EA, Hwang WT, Lacey SF, Melenhorst JJ, Krevvata M, Carroll MP, Matsui WH, Wang Q, Dhodapkar MV, Dhodapkar K, Das R, Vogl DT, Weiss BM, Cohen AD, Mangan PA, Ayers EC, Nunez-Cruz S, Kulikovskaya I, Davis MM, Lamontagne A, Dengel K, Kerr ND, Young RM, Siegel DL, Levine BL, Milone MC, Maus MV, June CH. Anti-CD19 CAR T cells with high-dose melphalan and autologous stem cell transplantation for refractory multiple myeloma. JCI Insight. 2018 Apr 19;3(8):e120505. doi: 10.1172/jci.insight.120505. eCollection 2018 Apr 19.
- Derived from this study: 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.
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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.
Edward Stadtmauer, MD principal investigator
Abramson Cancer Center at Penn Medicine
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 CART-19 T cells in people with Multiple Myeloma, run by University of Pennsylvania at 1 site in United States.
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 0 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: finished, as of the sponsor's last update on 22 Jun 2023. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse Events (time frame: 2 years). 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 NCT02135406, which also lists 2 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 22 Jun 2023.