Multiple MyelomaPhase 1NCT04500431
Clinical Study to Evaluate the Safety and Feasibility of spCART-269 Injection in the Treatment of MM
A Phase 1 study testing Targeting CD269 chimeric antigen receptor engineered T cells in people with Multiple Myeloma, run by Shanghai Tongji Hospital, Tongji University School of Medicine at 1 site in China.
Trial summary
The trial is a single arm, single-center, non-randomized phase I clinical trial which is designed to evaluate the safety and efficacy of spCART-269 in treatment of relapsed or refractory multiple myeloma patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Targeting CD269 chimeric antigen receptor engineered T cells
- 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
- 1 Jul 2018to 1 Dec 2022
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient was diagnosed as active MM according to the diagnostic criteria of the International Myeloma Working Group (IMWG)
- The patient meets any of the following:
- Have received at least 3 treatment options in the past and include alkylating agents, proteasome inhibitors and immunomodulators;
- If the patient has received a regimen containing proteasome inhibitor and immunomodulator for at least 2 courses, and the effect is not good (such as disease progression within 60 days of treatment)
- Voluntary participation in clinical research and signing informed consent
- Age 18-65, regardless of gender
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- Expected survival time is greater than 12 weeks
- If the patient has received autologous hematopoietic stem cell transplantation in the past, a 90-day interval is required
- Normal bone marrow hematopoietic function, blood routine: hemoglobin ≥ 100 g/L; absolute neutrophil ≥ 1.5×10^9/L; platelet count ≥ 100×10^9/L
- Liver function: serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 (ULN) times the upper limit of normal value (if abnormal liver function is mainly caused by tumor infiltration, it can be ≤ 5 times the upper limit of normal value (ULN) )), bilirubin <2.0 mg/dL
- Renal function: BUN is 9-20 mg/dL, serum creatinine ≤ 1.5 times the upper limit of normal (ULN), endogenous creatinine clearance rate ≥50 ml/min
- Serum virus EBV, CMV, HBV, HCV, HIV and syphilis antibodies are negative
- Heart function: good hemodynamic stability, left ventricular ejection fraction (LVEF) ≥ 45%
- ECOG physical status score 0-2
- Possess apheresis or sufficient venous access for venous blood, and no other contraindications for leukocyte separation
- T cells can be successfully expanded in vitro
- Women of childbearing age who provide negative reports of pregnancy tests with serum or urine before reinfusion
- Adults with fertility requirements, regardless of sex, contraception within one year after treatment
Who cannot join
- ECOG score ≥ 3 points
- Female patients during pregnancy or lactation
- Pathological examination revealed malignant tumor cells with T cell origin
- Organ failure: Heart failure grade Ⅲ and Ⅳ; liver reaches Child-Turcotte liver function grade C; renal failure and uremia; respiratory failure; consciousness disorder
- Patients with acute or chronic GVHD after allogeneic hematopoietic transplantation, or using hormones or immunosuppressants within 30 days
- Patients with HIV infection or active hepatitis
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- There are other uncontrolled active infections
- Those who may be allergic to cytokines
- Those who have used any gene therapy products
- Those who participated in other clinical studies 4 weeks before enrollment (except those who did not receive treatment in clinical studies)
- Patients with systemic autoimmune diseases or immunodeficiency diseases
- Definite neuropathy or psychosis, including authors of dementia or epilepsy
- Those with lung or intestinal tumor infiltration
- Patients that other researchers think are not suitable for enrollment
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Tongji Hospital, Tongji University School of Medicine
Shanghai, Shanghai Municipality, 200065
Aibin Liang, MD, Ph.D, 0086-021-66111019, lab7182@tongji.edu.cn
About this study
Official title: Clinical Study to Evaluate the Safety and Feasibility of Targeting CD269 Chimeric Antigen Receptor Engineered T Cell (spCART-269) Injection in the Treatment of CD269-positive Multiple Myeloma
The trial is a single arm, single-center, non-randomized phase I clinical trial which is designed to evaluate the safety and efficacy of spCART-269 in treatment of relapsed or refractory multiple myeloma patients.
Read the detailed description
This study plans to enroll 10 patients to assess the safety and efficacy of spCART-269. Subjects who meet the eligibility criteria will receive a single dose of spCART-269 injection. The study will include the following sequential phases: Screening, Pre-treatment (Cell product preparation; Lymphodepleting Chemotherapy), Treatment and follow-up.
- Conditions
- Multiple Myeloma
- Being tested
- Targeting CD269 chimeric antigen receptor engineered T cells
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeting CD269 chimeric antigen receptor engineered T cellsBiological
Also called spCART-269
Targeting CD269 chimeric antigen receptor engineered T cells, single infusion intravenously
| Study group | Role | What they receive |
|---|---|---|
| spCART-269 | Experimental | spCART-269 administered by intravenous (IV) infusion Receives: Biological: Targeting CD269 chimeric antigen receptor engineered T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of study related adverse events
Incidence and severity of Treatment emergent adverse events
Measured: 12 weeks
Secondary outcomes (4)
Overall response rate (ORR)
Measured: 12 months
Duration of remission (DOR)
Measured: 12 months
Progression free survival (PFS)
Measured: 12 months
Overall survival (OS)
Measured: 12 weeks, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start1 Jul 2018
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Dec 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Tongji Hospital, Tongji University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aibin Liang，MD，Ph.D., Shanghai Tongji Hospital, Tongji University School of Medicine
- Investigators
- Aibin Liang, MD, Ph.D, Principal investigator, Shanghai Tongji Hospital, Tongji University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04500431
- Sponsor's protocol ID
- 200802
- Status last verified
- Aug 2020
- First submitted
- 2 Aug 2020
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sets generated and analysed during the current study are available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Safety and Feasibility of Targeting CD269 Chimeric Antigen Receptor Engineered T Cell (spCART-269) Injection in the Treatment of CD269-positive Multiple Myeloma
- ClinicalTrials.gov ID
- NCT04500431
- Acronym / sponsor ID
- 200802
- Conditions
- Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Shanghai Tongji Hospital, Tongji University School of MedicineUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 5 Aug 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 trial is a single arm, single-center, non-randomized phase I clinical trial which is designed to evaluate the safety and efficacy of spCART-269 in treatment of relapsed or refractory multiple myeloma patients.
Detailed description
This study plans to enroll 10 patients to assess the safety and efficacy of spCART-269. Subjects who meet the eligibility criteria will receive a single dose of spCART-269 injection. The study will include the following sequential phases: Screening, Pre-treatment (Cell product preparation; Lymphodepleting Chemotherapy), Treatment and follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| spCART-269 | Experimental | Biological: Targeting CD269 chimeric antigen receptor engineered T cellsspCART-269 administered by intravenous (IV) infusion |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- The patient was diagnosed as active MM according to the diagnostic criteria of the International Myeloma Working Group (IMWG)
- The patient meets any of the following:
- Voluntary participation in clinical research and signing informed consent
- Age 18-65, regardless of gender
- Expected survival time is greater than 12 weeks
Key exclusion criteria (14 listed)
- ECOG score ≥ 3 points
- Female patients during pregnancy or lactation
- Pathological examination revealed malignant tumor cells with T cell origin
- Organ failure: Heart failure grade Ⅲ and Ⅳ; liver reaches Child-Turcotte liver function grade C; renal failure and uremia; respiratory failure; consciousness disorder
- Patients with acute or chronic GVHD after allogeneic hematopoietic transplantation, or using hormones or immunosuppressants within 30 days
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 |
|---|---|---|
| Targeting CD269 chimeric antigen receptor engineered T cellsAlso: spCART-269Targeting CD269 chimeric antigen receptor engineered T cells, single infusion intravenously | Biological | spCART-269 |
Primary outcome
Occurrence of study related adverse events
Time frame: 12 weeks
Incidence and severity of Treatment emergent adverse events
4 secondary outcomes
Overall response rate (ORR)
Time frame: 12 months
Duration of remission (DOR)
Time frame: 12 months
Progression free survival (PFS)
Time frame: 12 months
Overall survival (OS)
Time frame: 12 weeks, 6 months, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2020.
- Individual participant dataSharing planned: Yes. The data sets generated and analysed during the current study are available from the corresponding author on reasonable request.
Related trials for Multiple Myeloma
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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.
Aibin Liang, MD, Ph.D principal investigator
Shanghai Tongji Hospital, Tongji University School of 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 Targeting CD269 chimeric antigen receptor engineered T cells in people with Multiple Myeloma, run by Shanghai Tongji Hospital, Tongji University School of Medicine 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 18 inclusion and 14 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 5 Aug 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?
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 Aibin Liang, MD, Ph.D (0086-021-66111019, lab7182@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of study related adverse events (time frame: 12 weeks). 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 5 Aug 2020.