Multiple Myeloma in RelapsePhase 1NCT04861480
Dual-target CAR-T Cells (C-4-29) in the Treatment of Relapsed/Refractory Multiple Myeloma
A Phase 1 study testing C-4-29 Cells in people with Multiple Myeloma in Relapse and Multiple Myeloma, Refractory, run by Chongqing Precision Biotech Co., Ltd at 1 site in China.
Trial summary
This is a phase I clinical study to evaluate the safety and tolerability of C-4-29 in patients with relapsed or refractory multiple myeloma, and to obtain the maximum tolerated dose of C-4-29 and phase II Recommended dose. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma in Relapse, Multiple Myeloma, Refractory
- What is being tested?
- C-4-29 Cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 16 Jun 2021to 18 Jul 2024
- 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
- ≥18 years old, no gender limit;
- Diagnosed with multiple myeloma according to the IMWG diagnostic criteria.
- Received third-line and above regular treatments (including proteasome inhibitors or immunomodulators) that are ineffective or intolerable;
- The disease is measurable during screening:
- Serum M protein level ≥0.5g/dL, or urine M protein level ≥200mg/24h;
- Or light chain type MM with undetectable serum or urine disease: serum immunoglobulin free light chain ≥10mg/dL and serum immunoglobulin κ/γ free light chain ratio is abnormal;
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- Or evaluable extramedullary lesions with the largest transverse diameter ≥ 1 cm.
- ECOG 0～2 points;
- The expected survival time is more than 12 weeks;
- No serious mental disorders;
- The function of important organs is basically normal:
- Heart function: echocardiography indicates that the cardiac ejection fraction is ≥50%, and the electrocardiogram has no obvious abnormalities;
- Renal function: serum creatinine≤2.0×ULN;
- Liver function: ALT and AST ≤3×ULN;
- Total bilirubin and alkaline phosphatase≤2×ULN (Gilbert syndrome≤3.0×ULN);
- Blood oxygen saturation>92%.
- Have standards for apheresis or venous blood collection, and no other cell collection contraindications;
- The subject agrees to use reliable and effective contraceptive methods for contraception within 1 year after signing the informed consent form to receiving C-4-29 cell infusion (excluding safe period contraception).
- The patient himself or his guardian agrees to participate in the clinical trial and signs the ICF, indicating that he understands the purpose and procedures of the clinical trial and is willing to participate in the research.
Who cannot join
- Have received CAR-T therapy or other genetically modified cell therapy;
- With central nervous system disease at the time of screening ;
- Participated in other clinical studies within 1 month before screening;
- Have received a live attenuated vaccine within 4 weeks before screening;
- Have received the following anti-tumor treatments before apheresis: received chemotherapy, targeted therapy or other experimental drug treatments within 14 days or at least 5 half-lives (whichever is shorter);
- Within 7 days before apheresis, there are active infections or uncontrollable infections that require systemic treatment (except CTCAE grade 1 genitourinary system infection and upper respiratory tract infection);
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- Suffered from plasma cell leukemia at the time of screening ;
- Suffered from other malignant tumors other than multiple myeloma within 3 years before screening, except for the following cases: malignant tumors that have received radical treatment, and there is no known active disease for ≥3 years before enrollment; or fully treated non-melanoma skin cancer with no evidence of disease;
- Except for hair loss or peripheral neuropathy, the toxicity of previous anti-tumor treatments has not improved to the baseline level or ≤grade 1;
- Subjects who have received systemic steroid treatment within 7 days before apheresis or who have been determined by the investigator to require long-term systemic steroid treatment during treatment (except for inhaled or topical use);
- Suffered from any of the following heart diseases:
- NYHA stage III or IV congestive heart failure;
- Myocardial infarction or CABG occurred ≤6 months before enrollment;
- Clinically significant ventricular arrhythmia, or history of unexplained syncope (except for cases caused by vasovagal or dehydration);
- History of severe non-ischemic cardiomyopathy.
- Active autoimmune diseases;
- HBsAg or HBcAb positive and HBV DNA is greater than the normal range; HCV antibody is positive and HCV RNA greater than the normal range; HIV antibody positive; syphilis positive; CMV DNA positive;
- Have experienced a venous embolism event (for example: pulmonary embolism or deep vein thrombosis) and requires anticoagulation therapy or the subject meets the following conditions: a. Bleeding of grade 3 to 4 lasting more than 30 days; b. Have sequelae caused by venous thrombosis (such as persistent dyspnea and hypoxia);
- Women who are pregnant or breastfeeding, and male or female subjects who plan to have children within 1 year after receiving C-4-29 cell reinfusion;
- Other situations considered by the researcher to be unsuitable to participate in the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
About this study
Official title: Phase I Clinical Study of CAR-T Cells (C-4-29) in the Treatment of Patients With Relapsed/Refractory Multiple Myeloma
This is a phase I clinical study to evaluate the safety and tolerability of C-4-29 in patients with relapsed or refractory multiple myeloma, and to obtain the maximum tolerated dose of C-4-29 and phase II Recommended dose.
Read the detailed description
This is a multi-center, single-arm, open-label study. The study plans to set up 3 dose groups, adopting a dose-escalating 3+3 design, and plan to recruit about 9-18 subjects with relapsed or refractory multiple myeloma.C-4-29 cells will be infused to the subject by intravenous infusion.
- Being tested
- C-4-29 Cells
- Keywords
- Multiple Myeloma, 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.
C-4-29 CellsBiological
Drug: C-4-29 Cells； Administration method: intravenous infusion； Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion.
| Study group | Role | What they receive |
|---|---|---|
| C-4-29 cells | Experimental | Infusion of C-4-29 cells by dose-escalating Receives: Biological: C-4-29 Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse events after C-4-29 infusion [Safety and Tolerability]
Therapy-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
Measured: 28 days
Obtain the maximum tolerated dose of C-4-29 cells[Safety and Tolerability]
Dose-limiting toxicity after cell infusion
Measured: 28 days
Secondary outcomes (7)
Objective response rate after C-4-29 infusion [Effectiveness]
Objective response rate includes sCR, CR, VGPR, PR, MR
Measured: 3 months
AUCS of C-4-29 cells [Cell dynamics]
AUCS is defined as the area under the curve in 28 days
Measured: 3 months
CMAX of C-4-29 cells [Cell dynamics]
CMAX is defined as the highest concentration of C-4-29 cells expanded in peripheral blood
Measured: 3 months
TMAX of C-4-29 cells [Cell dynamics]
TMAX is defined as the time to reach the highest concentration
Measured: 3 months
Peripheral blood M protein contents after C-4-29 infusion [Cell dynamics]
Periodic detection of Peripheral blood M protein after cell infusion
Measured: 3 months
Urine Bence-Jones protein contents after C-4-29 infusion [Cell dynamics]
Periodic detection of Urine Bence-Jones protein after cell infusion
Measured: 3 months
Immunogenicity of C-4-29 cells
Anti-CAR antibody
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start16 Jun 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion18 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma in RelapseStudies of the same condition, open and under way.
- More trials run by Chongqing Precision Biotech Co., LtdThe 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
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing Precision Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04861480
- Sponsor's protocol ID
- PB04
- Status last verified
- Apr 2023
- First submitted
- 6 Apr 2021
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study of CAR-T Cells (C-4-29) in the Treatment of Patients With Relapsed/Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT04861480
- Acronym / sponsor ID
- PB04
- Keywords
- Multiple Myeloma, CAR-T
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Chongqing Precision Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 16 Jun 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 18 Jul 2024 (estimated)
- First posted
- 27 Apr 2021 (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.
This is a phase I clinical study to evaluate the safety and tolerability of C-4-29 in patients with relapsed or refractory multiple myeloma, and to obtain the maximum tolerated dose of C-4-29 and phase II Recommended dose.
Detailed description
This is a multi-center, single-arm, open-label study. The study plans to set up 3 dose groups, adopting a dose-escalating 3+3 design, and plan to recruit about 9-18 subjects with relapsed or refractory multiple myeloma.C-4-29 cells will be infused to the subject by intravenous infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| C-4-29 cells | Experimental | Biological: C-4-29 CellsInfusion of C-4-29 cells by dose-escalating |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- ≥18 years old, no gender limit;
- Diagnosed with multiple myeloma according to the IMWG diagnostic criteria.
- Received third-line and above regular treatments (including proteasome inhibitors or immunomodulators) that are ineffective or intolerable;
- The disease is measurable during screening:
- ECOG 0～2 points;
Key exclusion criteria (20 listed)
- Have received CAR-T therapy or other genetically modified cell therapy;
- With central nervous system disease at the time of screening ;
- Participated in other clinical studies within 1 month before screening;
- Have received a live attenuated vaccine within 4 weeks before screening;
- Have received the following anti-tumor treatments before apheresis: received chemotherapy, targeted therapy or other experimental drug treatments within 14 days or at least 5 half-lives (whichever is shorter);
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 |
|---|---|---|
| C-4-29 CellsDrug: C-4-29 Cells； Administration method: intravenous infusion； Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion. | Biological | C-4-29 cells |
Primary outcome
Incidence of Adverse events after C-4-29 infusion [Safety and Tolerability]
Time frame: 28 days
Therapy-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
Obtain the maximum tolerated dose of C-4-29 cells[Safety and Tolerability]
Time frame: 28 days
Dose-limiting toxicity after cell infusion
7 secondary outcomes
Objective response rate after C-4-29 infusion [Effectiveness]
Time frame: 3 months
AUCS of C-4-29 cells [Cell dynamics]
Time frame: 3 months
CMAX of C-4-29 cells [Cell dynamics]
Time frame: 3 months
TMAX of C-4-29 cells [Cell dynamics]
Time frame: 3 months
Peripheral blood M protein contents after C-4-29 infusion [Cell dynamics]
Time frame: 3 months
Urine Bence-Jones protein contents after C-4-29 infusion [Cell dynamics]
Time frame: 3 months
Immunogenicity of C-4-29 cells
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 C-4-29 Cells in people with Multiple Myeloma in Relapse and Multiple Myeloma, Refractory, run by Chongqing Precision Biotech Co., Ltd 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 19 inclusion and 20 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 18 Apr 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 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?
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?
Incidence of Adverse events after C-4-29 infusion [Safety and Tolerability] (time frame: 28 days). The study lists 2 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 18 Apr 2023.