Multiple MyelomaPhase 1NCT05698303
A Study of Fully Human BCMA Chimeric Antigen Receptor Autologous T Cell Injection (CT103A) in the Treatment of Patients With Relapsed/Refractory Multiple Myeloma
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 1 site in United States.
Trial summary
It is a dose expansion, open-label, phase Ib study to evaluate the safety, efficacy, pharmacokinetic (PK), pharmacodynamic (PD), and immunogenicity of CT103A in patients with relapsed/refractory multiple myeloma. 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?
- 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
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2023to 15 Jan 2026
- 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 of age.
- Documented diagnosed with multiple myeloma according to the IMWG diagnostic criteria.
- Have received at least 3 prior lines of therapy, including a proteasome inhibitor, an immunomodulator-based chemotherapy, and an anti-CD38 therapy (prior exposure can be from different monotherapy or combination regimens), or are refractory to both a proteasome inhibitor and an immunomodulatory agent (i.e., double refractory).
- Documented disease progression during or within 12 months of the most recent anti-myeloma treatment (except for subjects who received CAR-T as last-line therapy).
- For subjects with previous BCMA-targeted therapy, the best response should be at least PR, and positive BCMA expression on tumor cells by immunohistochemistry (IHC) or flow cytometry is required before enrollment.
- The presence of measurable lesion according to IMWG 2016 criteria at screening as determined by any of the following criteria:
Show all 19Show fewer
- Serum M-protein level ≥1.0 g/dL or urine M protein level ≥ 200 mg/24 h; or
- Light chain multiple myeloma without measurable lesions in serum or urine: Involved serum free light chain ≥ 10 mg/dL and abnormal serum κ/λ free light chain ratio.
- ECOG score of 0 or 1 (refer to Appendix 2)
- Subjects must have appropriate organ function and meet all the following laboratory test results prior to enrollment:
- Hematology: Absolute neutrophil count (ANC) ≥ 1×109/L (supportive growth factor is permitted, but must be without supportive treatment within 7 days before the laboratory test); absolute lymphocyte count (ALC) ≥0.3×109/L; platelet count ≥50×109/L (must be without supportive blood transfusion within 7 days before the laboratory test); hemoglobin ≥80 g/L (without transfusion of red blood cells [RBC] within 7 days before the laboratory test; the use of recombinant human erythropoietin is permitted).
- Liver function: Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5×upper limit of normal (ULN); serum total bilirubin ≤ 1.5×ULN except with known Gilbert's syndrome who have serum bilirubin ≤ 3×ULN.
- Renal function: Creatinine clearance (CrCl) calculated using the 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.
- Corrected serum calcium ≤11 mg/dL
- Oxygen saturation (by Fingertip Pulse Oximeter) ≥92%.
- Left ventricular ejection fraction (LVEF) ≥45%.
- Female subjects of childbearing potential or male subjects with a partner of childbearing potential agree to use effective contraception methods from screening and continued during study treatment until one year after the last dose.
- The subject must personally sign an informed consent form approved by the ethics committee in writing.
Who cannot join
- Subjects with graft versus host disease (GVHD) or those requiring long-term use of immunosuppressants.
- Received autologous hematopoietic stem cell transplant (Auto-HSCT) within 12 weeks before apheresis or received prior allogeneic hematopoietic stem cell transplant (Allo-HSCT).
- Received prior anti-myeloma therapies as follows:
- Treatment with monoclonal antibodies within 21 days prior to apheresis, or
- Treatment with cytotoxic chemotherapy or proteasome inhibitor within 14 days prior to apheresis, or
- Treatment with immunomodulator within 7 days prior to apheresis, or
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- Anti-myeloma therapies other than those described above within 14 days or at least 5 half-lives (whichever is shorter) prior to apheresis.
- Use of glucocorticoids (defined as prednisone or equivalent > 20 mg/day) at a therapeutic dose within 7 days prior to apheresis. Physiologic replacement, topical, and inhalation steroids are permitted, nevertheless.
- Severe heart disease: Including but not limited to unstable angina, myocardial infarction (within 6 months prior to screening), congestive cardiac 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 requiring therapy.
- Malignancies other than multiple myeloma within 5 years prior to screening, excluding adequately treated carcinoma in situ of cervix, basal or squamous epithelial cell skin cancer, localized prostate cancer post radical operation, ductal carcinoma in situ of the breast post radical operation.
- History of organ transplant.
- Suspected or confirmed central nervous system involvement.
- Plasma cell leukemia at the time of screening (>2.0×109/L plasma cells by standard differential), Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary AL amyloidosis.
- Major surgery within 2 weeks prior to apheresis, or planned surgery within 2 weeks after study treatment administration (subjects who plan to receive surgery under local anesthesia are permitted to be enrolled in this study).
- Treated with other interventional clinical investigational products within 1 month before signing the informed consent form (ICF).
- Evidence of serious active viral, bacterial, or uncontrolled systemic fungal infection prior to apheresis.
- Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with detectable hepatitis B virus (HBV) DNA in peripheral blood; positive hepatitis C virus (HCV) antibody with positive HCV RNA in peripheral blood; positive human immunodeficiency virus (HIV) antibody; positive cytomegalovirus (CMV) DNA; positive syphilis test.
- Pregnant or breastfeeding women or planning to become pregnant while enrolled in this study or within 1 year after receiving study treatment.
- Stroke, seizure or psychosis within 6 months of signing ICF.
- Non-hematological toxicities from previous anti-myeloma therapy have not recovered to baseline or grade ≤1 (NCI-CTCAE v5.0, except for alopecia and grade 2 peripheral neuropathy).
- Any issue that would impair the ability of the subject to receive or tolerate the planned treatment, to understand informed consent or any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Robert Z. Orlowski, M.D., Ph.D., 713-792-2860, rorlowsk@mdanderson.org
About this study
Official title: A Phase Ib Clinical Study of Fully Human BCMA Chimeric Antigen Receptor Autologous T Cell Injection (CT103A) in the Treatment of Patients With Relapsed/Refractory Multiple Myeloma
It is a dose expansion, open-label, phase Ib study to evaluate the safety, efficacy, pharmacokinetic (PK), pharmacodynamic (PD), and immunogenicity of CT103A in patients with relapsed/refractory multiple myeloma.
Read the detailed description
A total of at least 12 subjects are planned to be enrolled in this study. Each subject will proceed through the following study periods:
- Screening
- Leukapheresis
- Bridging therapy (at the discretion of the investigator)
- Pre-lymphodepletion assessment
- Lymphodepleting chemotherapy
- Pre-infusion Assessment
- CT103A infusion (Day 0)
- 28-Day safety evaluation period
- Post-treatment follow-up period (Day 29 through year 2)
All the subjects will be followed for safety and efficacy until disease progression, initiation of subsequent anti-myeloma therapy, withdrawal, death, loss to follow-up, study completion, end of study, or study termination, whichever occurs first. Subjects except those that are deceased, lost to follow-up, or have withdrawn their ICF will enter the long-term follow-up (LTFU) under a separate protocol for at least 15 years.
- Conditions
- Multiple Myeloma
- Being tested
- Fully human BCMA chimeric antigen receptor autologous T cell injection (CT103A)
- Keywords
- relapsed/refractory multiple myeloma, RRMM, CAR-T, BCMA
- 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 an BCMA targeted genetically modified autologous T cell immunotherapy product that identifies and eliminates BCMA-expressing malignant and normal cells. CAR specifically recognizes BCMA with a low-immunogenic fully human single chain fragment variable (scFv), promotes CAR-T activation, proliferation, cytokine secretion and target cell killing through the CD3ζ domain, and enhances CAR-T proliferation and persistence through co-stimulatory signaling via 4-1BB.
| Study group | Role | What they receive |
|---|---|---|
| CT103A in patients with RRMM | Experimental | After lymphodepletion, CT103A will be administered as a single infusion. 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.
Incidence and severity of adverse events
An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0, with the exception of cytokine release syndrome (CRS), and immune effector cell-associated neurotoxicity syndrome (ICANS).
Measured: Up to 2 years after CT103A infusion.
Incidence and severity of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS)
CRS and ICANS will be evaluated according to the American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading.
Measured: Up to 2 years after CT103A infusion.
Number of participants with laboratory abnormalities
Number of participants with laboratory abnormalities will be reported.
Measured: Up to 2 years after CT103A infusion.
Secondary outcomes (10)
Overall response rate (ORR)
The proportion of subjects who achieved at least a PR or better as defined by the International Myeloma Working Group (IMWG) response criteria.
Measured: Up to 2 years after CT103A infusion.
Progression-free survival (PFS)
Duration from the date of CT103A infusion to the date of first documented evidence of progressive disease or death due to any cause.
Measured: Up to 2 years after CT103A infusion.
Overall survival (OS)
Duration from the start of CT103A treatment to subject death (due to any cause).
Measured: Up to 2 years after CT103A infusion.
Duration of response (DOR)
Duration from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the IMWG criteria.
Measured: Up to 2 years after CT103A infusion.
Time to response (TTR)
Time interval from the date of CT103A infusion to the date of initial documentation of a response (PR or better)
Measured: Up to 2 years after CT103A infusion.
Time to complete response (TTCR)
Time interval from the date of CT103A infusion to the date of initial documentation of a complete response (CR) or stringent complete response (sCR).
Measured: Up to 2 years after CT103A infusion.
MRD response assessment
The proportion of subjects achieved MRD-negativity.
Measured: Up to 2 years after CT103A infusion.
The duration of MRD-negativity
The duration of MRD-negativity is defined as the time interval between the first occurrence of negative MRD after infusion and the first reversal of negative MRD results to positive.
Measured: Up to 2 years after CT103A infusion.
CAR transgene level in peripheral blood.
The CAR transgene level in peripheral blood both pre- and post- CT103A infusion will be measured and reported.
Measured: Up to 2 years after CT103A infusion.
Soluble BCMA (sBCMA) in peripheral blood.
The level of sBCMA in peripheral blood will be measured and reported.
Measured: Up to 2 years 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 posted26 Jan 2023
- Study start8 May 2023 (estimated)
- Primary completion20 May 2024 (estimated)
- Study completion15 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Nanjing IASO Biotechnology Co., Ltd.The 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
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing IASO Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nanjing IASO Biotherapeutics Co.,Ltd. Clinical trial, Study director, Nanjing IASO Biotechnology Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05698303
- Sponsor's protocol ID
- CT103AA001
- Status last verified
- Dec 2022
- First submitted
- 29 Dec 2022
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Keam SJ. Equecabtagene Autoleucel: First Approval. Mol Diagn Ther. 2023 Nov;27(6):781-787. doi: 10.1007/s40291-023-00673-y. Epub 2023 Sep 2.
PubMed 37658205
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Clinical Study of Fully Human BCMA Chimeric Antigen Receptor Autologous T Cell Injection (CT103A) in the Treatment of Patients With Relapsed/Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05698303
- Acronym / sponsor ID
- CT103AA001
- Conditions
- Multiple Myeloma
- Keywords
- relapsed/refractory multiple myeloma, RRMM, CAR-T, BCMA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Nanjing IASO Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 May 2023 (estimated)
- Primary completion
- 20 May 2024 (estimated)
- Study completion
- 15 Jan 2026 (estimated)
- First posted
- 26 Jan 2023 (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.
It is a dose expansion, open-label, phase Ib study to evaluate the safety, efficacy, pharmacokinetic (PK), pharmacodynamic (PD), and immunogenicity of CT103A in patients with relapsed/refractory multiple myeloma.
Detailed description
A total of at least 12 subjects are planned to be enrolled in this study. Each subject will proceed through the following study periods:
- Screening
- Leukapheresis
- Bridging therapy (at the discretion of the investigator)
- Pre-lymphodepletion assessment
- Lymphodepleting chemotherapy
- Pre-infusion Assessment
- CT103A infusion (Day 0)
- 28-Day safety evaluation period
- Post-treatment follow-up period (Day 29 through year 2)
All the subjects will be followed for safety and efficacy until disease progression, initiation of subsequent anti-myeloma therapy, withdrawal, death, loss to follow-up, study completion, end of study, or study termination, whichever occurs first. Subjects except those that are deceased, lost to follow-up, or have withdrawn their ICF will enter the long-term follow-up (LTFU) under a separate protocol for at least 15 years.
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 patients with RRMM | Experimental | Drug: Fully human BCMA chimeric antigen receptor autologous T cell injection (CT103A)After lymphodepletion, CT103A will be administered as a single infusion. |
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 of age.
- Documented diagnosed with multiple myeloma according to the IMWG diagnostic criteria.
- Have received at least 3 prior lines of therapy, including a proteasome inhibitor, an immunomodulator-based chemotherapy, and an anti-CD38 therapy (prior exposure can be from different monotherapy or combination regimens), or are refractory to both a proteasome inhibitor and an immunomodulatory agent (i.e., double refractory).
- Documented disease progression during or within 12 months of the most recent anti-myeloma treatment (except for subjects who received CAR-T as last-line therapy).
- For subjects with previous BCMA-targeted therapy, the best response should be at least PR, and positive BCMA expression on tumor cells by immunohistochemistry (IHC) or flow cytometry is required before enrollment.
Key exclusion criteria (22 listed)
- Subjects with graft versus host disease (GVHD) or those requiring long-term use of immunosuppressants.
- Received autologous hematopoietic stem cell transplant (Auto-HSCT) within 12 weeks before apheresis or received prior allogeneic hematopoietic stem cell transplant (Allo-HSCT).
- Received prior anti-myeloma therapies as follows:
- Use of glucocorticoids (defined as prednisone or equivalent > 20 mg/day) at a therapeutic dose within 7 days prior to apheresis. Physiologic replacement, topical, and inhalation steroids are permitted, nevertheless.
- Severe heart disease: Including but not limited to unstable angina, myocardial infarction (within 6 months prior to screening), congestive cardiac failure (New York Heart Association [NYHA] classification grade ≥ III), severe arrhythmia.
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 an BCMA targeted genetically modified autologous T cell immunotherapy product that identifies and eliminates BCMA-expressing malignant and normal cells. CAR specifically recognizes BCMA with a low-immunogenic fully human single chain fragment variable (scFv), promotes CAR-T activation, proliferation, cytokine secretion and target cell killing through the CD3ζ domain, and enhances CAR-T proliferation and persistence through co-stimulatory signaling via 4-1BB. | Drug | CT103A in patients with RRMM |
Primary outcome
Incidence and severity of adverse events
Time frame: Up to 2 years after CT103A infusion.
An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0, with the exception of cytokine release syndrome (CRS), and immune effector cell-associated neurotoxicity syndrome (ICANS).
Incidence and severity of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS)
Time frame: Up to 2 years after CT103A infusion.
CRS and ICANS will be evaluated according to the American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading.
Number of participants with laboratory abnormalities
Time frame: Up to 2 years after CT103A infusion.
Number of participants with laboratory abnormalities will be reported.
10 secondary outcomes
Overall response rate (ORR)
Time frame: Up to 2 years after CT103A infusion.
Progression-free survival (PFS)
Time frame: Up to 2 years after CT103A infusion.
Overall survival (OS)
Time frame: Up to 2 years after CT103A infusion.
Duration of response (DOR)
Time frame: Up to 2 years after CT103A infusion.
Time to response (TTR)
Time frame: Up to 2 years after CT103A infusion.
Time to complete response (TTCR)
Time frame: Up to 2 years after CT103A infusion.
MRD response assessment
Time frame: Up to 2 years after CT103A infusion.
The duration of MRD-negativity
Time frame: Up to 2 years after CT103A infusion.
CAR transgene level in peripheral blood.
Time frame: Up to 2 years after CT103A infusion.
Soluble BCMA (sBCMA) in peripheral blood.
Time frame: Up to 2 years after CT103A infusion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Derived from this study: PubMed 37658205Keam SJ. Equecabtagene Autoleucel: First Approval. Mol Diagn Ther. 2023 Nov;27(6):781-787. doi: 10.1007/s40291-023-00673-y. Epub 2023 Sep 2.
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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.
Nanjing IASO Biotherapeutics Co.,Ltd. Clinical trial study director
Nanjing IASO Biotechnology Co., Ltd.
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 Fully human BCMA chimeric antigen receptor autologous T cell injection (CT103A) in people with Multiple Myeloma, run by Nanjing IASO Biotechnology Co., Ltd. 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 19 inclusion and 22 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 26 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert Z. Orlowski, M.D., Ph.D. (713-792-2860, rorlowsk@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (time frame: Up to 2 years after CT103A infusion.). The study lists 3 primary outcomes in all. 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 NCT05698303, which also lists 1 linked publication.
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 26 Jan 2023.