Multiple MyelomaPhase 1NCT05181501
A Study of Fully Human BCMA CAR-T (CT103A) in Patients With Newly Diagnosed High-risk Multiple Myeloma (FUMANBA-2)
A Phase 1 study testing Fully human BCMA chimeric antigen receptor autologous T cell injection (CT103A) in people with Multiple Myeloma, run by Nanjing IASO Biotechnology Co., Ltd. at 4 sites in China.
Trial summary
This study is a multi-center, single-arm clinical study to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamic characteristics of CT103A as the first-line treatment in newly diagnosed high-risk multiple myeloma subjects with induction chemotherapy as bridging therapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Fully human BCMA chimeric antigen receptor autologous T cell injection (CT103A)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 4 sitesChina
- Study dates
- Apr 2022to Apr 2039
- Phase
- Phase 1
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 70 years old, male or female;
- Newly diagnosed as high-risk multiple myeloma:
- Revised Multiple Myeloma International Staging System (R-ISS) stage 3;
- Double-hit or triple-hit according to FISH test.
- Presence of measurable lesions during screening according to any of the following criteria:
- The proportion of primitive naive or monoclonal plasma cells ≥ 5% by bone marrow cytology, bone marrow biopsy histology or flow cytometry;
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- Serum monoclonal protein (M-protein) level: M protein ≥10 g/L for IgG type, M protein ≥5g/L for IgA, IgD, IgM, and IgE type;
- Urine M protein level ≥200 mg/24 hours;
- Light chain multiple myeloma without measurable lesions in serum or urine: the affected serum free light chain ≥100 mg/L with abnormal serum κ/λ free light chain ratio;
- ECOG score of 0 or 1;
- Expected survival time ≥ 12 weeks;
- Subjects must have appropriate organ functions and meet all the following laboratory test requirements before enrollment:
- Hematology: Absolute neutrophil count (ANC) ≥ 1×10^9/L (prior growth factor support is allowed, but supportive treatment within 7 days before laboratory test is not allowed); Absolute lymphocyte count (ALC) )≥0.3×10^9/L; platelets≥75×10^9/L (blood transfusion support within 7 days before laboratory test is not allowed); hemoglobin ≥60 g/L (without red blood cell [RBC] transfusion within 7 days before laboratory test; recombinant human erythropoietin is allowed);
- Liver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤2.5×upper limit of normal (ULN); serum total bilirubin≤1.5×ULN;
- Renal function: creatinine clearance calculated according to Cockcroft-Gault formula≥ 40 ml/min.
- Coagulation function: fibrinogen ≥1.0 g/L; activated partial thromboplastin time≤1.5×ULN, prothrombin time (PT)≤1.5×ULN;
- Blood oxygen saturation>91%;
- Left ventricular ejection fraction (LVEF) ≥50%;
- Subjects and their spouses agree to take effective tools or contraceptive measures (safe period contraception is not included) from the time the subject signs the informed consent form until one year after the CAR-T cell infusion.
Who cannot join
- Patient who needs chronic use of immunosuppressive agents;
- Patient with hypertension that cannot be controlled by medication;
- Severe heart disease: including but not limited to unstable angina, myocardial infarction (within 6 months before screening), congestive heart failure (New York Heart Association [NYHA] classification ≥ grade III), severe arrhythmia;
- Unstable systemic diseases judged by the investigator: including but not limited to severe liver, kidney or metabolic diseases that require drug treatment;
- Patients with malignant tumors other than multiple myeloma within 5 years before screening, excluding fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical resection, and those after radical resection Ductal carcinoma in situ of breast;
- Patient with a history of solid organ transplantation;
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- Patient who is suspected with or with symptoms of central nervous system invasion by plasma cell tumors;
- Multiple myeloma patients with plasma cell leukemia;
- Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and detectable hepatitis B virus (HBV) DNA in peripheral blood; hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus ( HCV) RNA positive; human immunodeficiency virus (HIV) antibody positive; cytomegalovirus (CMV) DNA test positive; syphilis test positive;
- Women who are pregnant or breastfeeding;
- Patient with mental illness or disturbance of consciousness or central nervous system disease;
- Major surgery history within 2 weeks before entering the study, or scheduled surgery during the study period or within 2 weeks after the study treatment;
- Other situations considered unsuitable by the investigator.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites
The First People's Hospital of Changzhou
Changzhou, Jiangsu
Weiying Gu, M.D., 0519-68871092, guweiying2001@163.com
Anhui Provincial Cancer Hospital
Hefei, Anhui
Kaiyang Ding, M.D., 13966672170, dingkaiy@126.com
Jiangsu Province Hospital
Nanjing, Jiangsu
Lijuan Chen, M.D., 025-68306091, chenljb@126.com
Nanjing Drum Tower Hospital
Nanjing, Jiangsu
Bing Chen, M.D., 025-83106666, chenbing2004@126.com
About this study
Official title: A Multi-center Clinical Study of Fully Human BCMA Chimeric Antigen Receptor Autologous T (CAR-T) Cell Injection (CT103A) in the Treatment of Newly Diagnosed Subjects With High-risk Multiple Myeloma (FUMANBA-2)
This study is a multi-center, single-arm clinical study to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamic characteristics of CT103A as the first-line treatment in newly diagnosed high-risk multiple myeloma subjects with induction chemotherapy as bridging therapy.
Read the detailed description
Before enrollment, subjects will receive chemotherapy regimen of either Bortezomib-Lenalidomide-Dexamethasone (VRD), Bortezomib-Cyclophosphamide-Dexamethasone (PCD) or Bortezomib-Adriamycin-Dexamethasone (PAD) as induction therapy for 3 cycles. Evaluation will be made after 2 cycles of chemotherapy. If the subject is not intended to have stem cell transplantation or unsuitable for autologous hematopoietic stem cell transplantation (ASCT) as judged by the investigator, he/she will receive the 3rd cycle of chemotherapy. If the subject meets the inclusion criteria, he/she will be enrolled in the study.
Peripheral blood mononuclear cell (PBMC) will be collected to manufacture CT103A. After PBMC collection, the subject will receive another cycle of chemotherapy and evaluated. Lymphodepletion with fludarabine and cyclophosphamide will be performed for three consecutive days. After 1-day rest, subjects will receive a single infusion of CT103A at 1.0 ×10^6 /kg. Subjects will be followed in the study for a minimum of 2 years after CT103A infusion. Long-term follow-up for lentiviral vector safety will be followed for up to 15 years after CT103A infusion.
- Conditions
- Multiple Myeloma
- Being tested
- Fully human BCMA chimeric antigen receptor autologous T cell injection (CT103A)
- Keywords
- newly diagnosed, multiple myeloma, treatment naive, 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.
Fully human BCMA chimeric antigen receptor autologous T cell injection (CT103A)Drug
Also called CT103A
CT103A is a customized, BCMA-targeted genetically modified autologous T cell immunotherapy, which can identify and eliminate malignant and normal cells expressing BCMA. CAR specifically recognizes BCMA with single chain fragment variable (ScFv), and promotes the activation, proliferation, cytokine secretion and target cell killing of CAR-T through the CD3ζ domain. And 4-1BB enhances the expansion and persistence of CT103A.
CT103A will be infused at 1.0×10^6 /kg via intravenous drip within 24h to 72h after chemotherapy conditioning regimen at the recommended infusion rate of 3-5 mL/min.
| Study group | Role | What they receive |
|---|---|---|
| CT103A in Newly Diagnosed Subjects With High-risk Multiple Myeloma | Experimental | Fully Human BCMA Chimeric Antigen Receptor Autologous T Cell Injection（CT103A）will be infused at 1.0 x 10^6 CAR+ T cells/kg in newly diagnosed subjects with high-risk multiple myeloma Receives: Drug: Fully human BCMA chimeric antigen receptor autologous T cell injection (CT103A) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Minimal Residual Disease (MRD)-negative subjects
The proportion of subjects who achieve MRD-negativity after CT103A infusion.
Measured: Up to 2 years after CT103A infusion
Median progression-free survival (mPFS)
The median time from the date of CT103A infusion to the date of first disease progression or death from any cause.
Measured: Up to 2 years after CT103A infusion
Secondary outcomes (10)
Best overall response (BOR)
The proportion of subjects who achieve stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) after CT103A infusion.
Measured: Up to 2 years after CT103A infusion
Median survival (mOS)
The median time from the date of CT103A infusion to the date of death from any reason.
Measured: Up to 2 years after CT103A infusion
Event-free survival (EFS)
The time from date of CT103A infusion to the date of death from any reason, relapse, treatment failure, disease progression or initiation of other anti-tumor treatment, whichever comes first;
Measured: Up to 2 years after CT103A infusion
Duration of response (DOR)
The time from the first assessment of sCR or CR or VGPR or PR to the first assessment of disease progression or death from any cause;
Measured: Up to 2 years after CT103A infusion
Safety endpoint
Incidence of treatment-emergent adverse events (TEAE) and Treatment-related adverse events (TRAE).
Measured: Up to 2 years after CT103A infusion
Pharmacokinetic(PK) endpoint
The maximum CT103A concentration and the copy number of the lentiviral vector (vector copy number, VCN) in peripheral blood (Cmax)
Measured: Up to 90 days after CT103A infusion
PK endpoint - Tmax
The time to reach the maximum concentration (Tmax)
Measured: Up to 90 days after CT103A infusion
PK endpoint - AUC 0 to 28d and AUC 0 to 90d
The area under the concentration time curve from time zero to day 28 (AUC0-28d) and from time zero to day 90 (AUC0-90d)
Measured: Up to 90 days after CT103A infusion
Levels of Soluable BCMA
The levels of soluble BCMA in peripheral blood at each time point.
Measured: Up to 90 days after CT103A infusion
PD endpoint
The levels of cytokines (IL-6, serum ferritin, etc.) in peripheral blood at each time point
Measured: Up to 90 days after CT103A infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study startApr 2022 (estimated)
- Primary completionApr 2024 (estimated)
- Study completionApr 2039 (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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing IASO Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lijuan Chen, M.D., Principal investigator, The First Affiliated Hospital with Nanjing Medical UniversityBing Chen, M.D., Principal investigator, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05181501
- Sponsor's protocol ID
- CT103ACI001
- Status last verified
- Jan 2022
- First submitted
- 21 Nov 2021
- Last updated
- 6 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Clinical Study of Fully Human BCMA Chimeric Antigen Receptor Autologous T (CAR-T) Cell Injection (CT103A) in the Treatment of Newly Diagnosed Subjects With High-risk Multiple Myeloma (FUMANBA-2)
- ClinicalTrials.gov ID
- NCT05181501
- Acronym / sponsor ID
- CT103ACI001
- Conditions
- Multiple Myeloma
- Keywords
- newly diagnosed, multiple myeloma, treatment naive, CAR-T
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Nanjing IASO Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2022 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Apr 2039 (estimated)
- First posted
- 6 Jan 2022 (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 study is a multi-center, single-arm clinical study to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamic characteristics of CT103A as the first-line treatment in newly diagnosed high-risk multiple myeloma subjects with induction chemotherapy as bridging therapy.
Detailed description
Before enrollment, subjects will receive chemotherapy regimen of either Bortezomib-Lenalidomide-Dexamethasone (VRD), Bortezomib-Cyclophosphamide-Dexamethasone (PCD) or Bortezomib-Adriamycin-Dexamethasone (PAD) as induction therapy for 3 cycles. Evaluation will be made after 2 cycles of chemotherapy. If the subject is not intended to have stem cell transplantation or unsuitable for autologous hematopoietic stem cell transplantation (ASCT) as judged by the investigator, he/she will receive the 3rd cycle of chemotherapy. If the subject meets the inclusion criteria, he/she will be enrolled in the study.
Peripheral blood mononuclear cell (PBMC) will be collected to manufacture CT103A. After PBMC collection, the subject will receive another cycle of chemotherapy and evaluated. Lymphodepletion with fludarabine and cyclophosphamide will be performed for three consecutive days. After 1-day rest, subjects will receive a single infusion of CT103A at 1.0 ×10^6 /kg. Subjects will be followed in the study for a minimum of 2 years after CT103A infusion. Long-term follow-up for lentiviral vector safety will be followed for up to 15 years after CT103A infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CT103A in Newly Diagnosed Subjects With High-risk Multiple Myeloma | Experimental | Drug: Fully human BCMA chimeric antigen receptor autologous T cell injection (CT103A)Fully Human BCMA Chimeric Antigen Receptor Autologous T Cell Injection（CT103A）will be infused at 1.0 x 10^6 CAR+ T cells/kg in newly diagnosed subjects with high-risk multiple myeloma |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 18 to 70 years old, male or female;
- Newly diagnosed as high-risk multiple myeloma:
- Presence of measurable lesions during screening according to any of the following criteria:
- ECOG score of 0 or 1;
- Expected survival time ≥ 12 weeks;
Key exclusion criteria (13 listed)
- Patient who needs chronic use of immunosuppressive agents;
- Patient with hypertension that cannot be controlled by medication;
- Severe heart disease: including but not limited to unstable angina, myocardial infarction (within 6 months before screening), congestive heart failure (New York Heart Association [NYHA] classification ≥ grade III), severe arrhythmia;
- Unstable systemic diseases judged by the investigator: including but not limited to severe liver, kidney or metabolic diseases that require drug treatment;
- Patients with malignant tumors other than multiple myeloma within 5 years before screening, excluding fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical resection, and those after radical resection Ductal carcinoma in situ of breast;
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 |
|---|---|---|
| Fully human BCMA chimeric antigen receptor autologous T cell injection (CT103A)Also: CT103ACT103A is a customized, BCMA-targeted genetically modified autologous T cell immunotherapy, which can identify and eliminate malignant and normal cells expressing BCMA. CAR specifically recognizes BCMA with single chain fragment variable (ScFv), and promotes the activation, proliferation, cytokine secretion and target cell killing of CAR-T through the CD3ζ domain. And 4-1BB enhances the expansion and persistence of CT103A. CT103A will be infused at 1.0×10^6 /kg via intravenous drip within 24h to 72h after chemotherapy conditioning regimen at the recommended infusion rate of 3-5 mL/min. | Drug | CT103A in Newly Diagnosed Subjects With High-risk Multiple Myeloma |
Primary outcome
Proportion of Minimal Residual Disease (MRD)-negative subjects
Time frame: Up to 2 years after CT103A infusion
The proportion of subjects who achieve MRD-negativity after CT103A infusion.
Median progression-free survival (mPFS)
Time frame: Up to 2 years after CT103A infusion
The median time from the date of CT103A infusion to the date of first disease progression or death from any cause.
10 secondary outcomes
Best overall response (BOR)
Time frame: Up to 2 years after CT103A infusion
Median survival (mOS)
Time frame: Up to 2 years after CT103A infusion
Event-free survival (EFS)
Time frame: Up to 2 years after CT103A infusion
Duration of response (DOR)
Time frame: Up to 2 years after CT103A infusion
Safety endpoint
Time frame: Up to 2 years after CT103A infusion
Pharmacokinetic(PK) endpoint
Time frame: Up to 90 days after CT103A infusion
PK endpoint - Tmax
Time frame: Up to 90 days after CT103A infusion
PK endpoint - AUC 0 to 28d and AUC 0 to 90d
Time frame: Up to 90 days after CT103A infusion
Levels of Soluable BCMA
Time frame: Up to 90 days after CT103A infusion
PD endpoint
Time frame: Up to 90 days after CT103A infusion
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 6 Jan 2022.
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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.
Lijuan Chen, M.D. principal investigator
The First Affiliated Hospital with Nanjing Medical University
Bing Chen, M.D. principal investigator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fully human BCMA chimeric antigen receptor autologous T cell injection (CT103A) in people with Multiple Myeloma, run by Nanjing IASO Biotechnology Co., Ltd. at 4 sites 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 13 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: opening soon, as of the sponsor's last update on 6 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
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 Lijuan Chen, M.D. (025-68306091, chenljb@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Minimal Residual Disease (MRD)-negative subjects (time frame: Up to 2 years after CT103A infusion). 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 6 Jan 2022; AzTrials last refreshed its copy on 26 Oct 2026.