Relapsed/Refractory Multiple Myeloma (MM)Early Phase 1CART-BCMANCT07458659
Clinical Study of BCMA-Targeted CAR T-Cell Injection in the Treatment of Patients With Relapsed/Refractory Multiple Myeloma
A Early Phase 1 study testing Chimeric Antigen Receptor T Cells (CAR-T) in people with Relapsed/Refractory Multiple Myeloma (MM), run by Chulalongkorn University at 1 site in Thailand.
Trial summary
A Phase 1b clinical trial to evaluate the safety and efficacy of BCMA-targeted CAR T-cell therapy in Thai patients with relapsed or refractory multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/Refractory Multiple Myeloma (MM)
- What is being tested?
- Chimeric Antigen Receptor T Cells (CAR-T)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jun 2026to 1 Jun 2029
- Phase
- Early 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age above 18 years old (inclusive), regardless of gender.
- Patients with multiple myeloma who have received at least three lines of treatment for multiple myeloma and have failed at least after treatment with proteasome inhibitors and immunomodulators; At least one complete cycle of each line of therapy, unless the best response to that therapy was documented as progressive disease (PD) (according to the 2016 published IMWG criteria for efficacy evaluation, Appendix 4); Patients must have PD records during or within 12 months after the last treatment or no response (no MR or better response) within 60 days after the last treatment.
- The presence of measurable lesions at screening was defined as any of the following:
- Serum M protein ≥ 1 g/dL (≥ 10 g/L)
- Urinary M-protein level ≥ 200 mg/24 hours
- Serum free light chains (FLC): abnormal serum FLC ratio (< 0.26 or > 1.65) with involved FLC ≥ 10 mg/dL (100 mg/L)
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- ECOG Performance Status (Appendix 1) of 0-1.
- Expected survival time ≥ 3 months.
- Meets the following criteria prior to mononuclear cell apheresis:
- Hematology
- Absolute count of lymphoid cells ≥ 0.5×109/L [Granulocyte colony-stimulating factor (G-CSF) is allowed, but this supportive treatment shall not be received by the test subjects within 7 days before laboratory tests during the screening period];
- Absolute neutrophil count ≥ 1.0 ×109/L [Granulocyte colony-stimulating factor (G-CSF) is allowed, but the subjects shall not receive this supportive treatment within 7 days before laboratory tests during the screening period];
- Platelet count ≥ 50×109/L (subjects must not receive blood transfusion support within 7 days before the screening laboratory test);
- Hemoglobin ≥ 8.0 g/dL (recombinant human erythropoietin is allowed) [subjects have not received red blood cells (RBCS) within 7 days prior to screening laboratory testing]; Heart
- Ejection function: Left ventricular ejection fraction (LVEF) ≥ 50% Lungs
- Oxygen saturation: A blood oxygen saturation of ≥ 91% on non-oxygen therapy Kidneys
- Creatinine clearance (CrCl) or glomerular filtration rate (GFR) (Cockcroft-Gault formula) ≥ 30 mL/min Liver
- Total bilirubin (serum) ≤ 1.5 × ULN Patients with Gilbert's disease and a serum bilirubin level of more than 1.5 × ULN could be enrolled after approval from the sponsor
- AST and ALT ≤ 3× ULN Clotting
- PT ≤ 1.5× ULN, APTT ≤ 1.5×ULN, INR ≤ 1.5×ULN
- Peripheral venous access can meet the requirements of apheresis and intravenous infusion.
- Subjects agreed to use a reliable contraceptive method for contraception from the time they signed the informed consent form until 1 year after infusion. These include, but are not limited to: abstinence, vasectomy in men, and an implantable progestin-based contraceptive that suppresses ovulation; Intrauterine contraceptive devices; Hormone-releasing intrauterine devices; Sexual partner sterilization; Copper intrauterine devices, proper use of combined hormonal contraceptives that have been shown to inhibit ovulation; Progestin-based contraceptives that inhibit ovulation. Female subjects should be at the same time commitment to lose after 1 year not to donate eggs (eggs, oocyte) used for assisted reproduction.
- They should voluntarily participate in the clinical trial and sign the informed consent.
Who cannot join
- Subjects with a known history of allergy, hypersensitivity, intolerance, or contraindication to any component of CART-BCMA or drugs that may be used in the study (including fludarabine, cyclophosphamide, tocilizumab); or subjects allergic to beta-lactam antibiotics; or subjects with a history of severe allergic reactions.
- Subjects who have previously received any CAR-T therapy or BCMA-targeted therapy.
- Subjects who have received the following anti-multiple myeloma (anti-MM) treatments within the specified time frame before apheresis:
- Small-molecule targeted therapy within 4 weeks or five half-lives, whichever was longer
- Macromolecular drug therapy within 4 weeks or 2 half-lives (whichever is longer)
- Cytotoxic therapy or proteasome inhibitor within 2 weeks
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- Immunomodulatory drug therapy within 1 week
- Radiotherapy within 1 week
- Subjects who have received any investigational drug within 4 weeks prior to apheresis or are concurrently participating in another clinical study (except for the following: subjects participating in observational, non-interventional clinical studies, or those in the follow-up period of an interventional clinical study).
- Patients who have received autologous hematopoietic stem cell transplantation (ASCT) within 12 weeks prior to apheresis or have previously received allogeneic stem cell transplantation (with no time limit).
- Subjects who have received live vaccines or attenuated vaccines within 4 weeks prior to CART-BCMA apheresis.
- Note: Administration of inactivated viral vaccines for seasonal influenza via injection is permitted; however, intranasal attenuated live influenza vaccines are not permitted.
- Subjects who have received any of the following treatments within 7 days prior to apheresis, or are judged by the investigator to require long-term receipt of such treatments during the study:
- Cumulative corticosteroids use equivalent to ≥ 70 mg prednisone within 7 days prior to apheresis, or long-term receipt of therapeutic-dose corticosteroids during the study as judged by the investigator
- Immunosuppressive therapy
- Graft-versus-host disease therapy
- Central nervous system (CNS) prophylactic therapy
- Toxicities resulting from previous treatments (including peripheral neuropathy) have not fully resolved or stabilized to Grade 1 (per NCI-CTCAE v5.0), except for those judged by the investigator to not affect the patient's safe receipt of treatment (e.g., alopecia).
- Any clinically significant past or current history of CNS disorders, such as altered mental status, psychosis, dementia, neurocognitive, neurodegenerative, or neuroinflammatory diseases (e.g., Alzheimer's disease, Parkinson's disease, multiple sclerosis), epilepsy, seizures, hemiplegia, aphasia, stroke, subarachnoid hemorrhage or other CNS hemorrhage, and severe traumatic brain injury. For subjects with history of such CNS alterations, they must have fully recovered at least 1 year before administration.
- Presence of meningeal, brainstem, spinal cord metastasis and/or compression, or active CNS metastasis; or suspected involvement of the CNS or meninges by multiple myeloma (MM), confirmed by magnetic resonance imaging (MRI) or computed tomography (CT).
- Suspected involvement of the CNS or meninges by MM (confirmed by MRI or CT), or presence of other active CNS diseases.
- Patients with plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, Skin changes), or amyloidosis at screening.
- Cardiac diseases: Current heart failure (New York Heart Association [NYHA] classification ≥ Class II, Appendix 2); severe cardiac diseases as determined by the investigator; myocardial infarction occurring ≤ 6 months before apheresis; unstable angina pectoris, severe arrhythmia (as judged by the investigator), or coronary artery bypass grafting (CABG) performed ≤ 3 months before apheresis.
- Poorly controlled hypertension (systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg), or a history of hypertensive crisis or hypertensive encephalopathy.
- Patients who have undergone major surgery (other than diagnostic procedures or biopsies) or plasmapheresis within 4 weeks before apheresis or are expected to undergo major surgery during the study. Note: Patients scheduled for surgical procedures under local anesthesia may participate in the study. Kyphoplasty or vertebroplasty is not considered major surgery.
- Subjects currently receiving thrombolytic, anticoagulant, or antiplatelet therapy.
- Subjects with infections requiring intravenous antibiotic administration or hospitalization.
- Subjects with active hepatitis B; subjects positive for hepatitis C virus (HCV) antibody and positive for HCV RNA; subjects positive for human immunodeficiency virus (HIV) antibody; subjects positive for syphilis screening antibody;
- Non-active/asymptomatic carrier, chronic, or active HBV-infected subjects may be enrolled if they meet the following criteria: HBV deoxyribonucleic acid (DNA) < 500 IU/mL (or 2500 copies/mL) at screening.
- Pregnant or lactating women.
- Subjects diagnosed with or treated for other invasive malignant tumors except multiple myeloma, except for the following cases: non-melanoma skin cancer that has been surgically removed, cured cervical carcinoma in situ, localized prostate cancer, low-stage bladder cancer, ductal carcinoma in situ of the breast, or malignant tumors with no recurrence and no treatment within 2 years before enrollment.
- Subjects deemed by the investigator to be unsuitable for participation in this clinical study due to any clinical or laboratory abnormalities or other reasons.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site
King Chulalongkorn Memorial Hospital
Bangkok, Pathumwan, 10330
Kritsada Wuttigorn, Associate Professor, MD, +66805623592, kitsada.w@chula.ac.th
Kritsada Wuttigorn, Associate Professor, MD
About this study
Official title: Phase Ib Clinical Study of BCMA-Targeted Chimeric Antigen Receptor T-Cell Injection (CART-BCMA) in the Treatment of Patients With Relapsed/Refractory Multiple Myeloma
A Phase 1b clinical trial to evaluate the safety and efficacy of BCMA-targeted CAR T-cell therapy in Thai patients with relapsed or refractory multiple myeloma.
Read the detailed description
The investigational product used in this study is a chimeric antigen receptor T-cell, also known as "CAR T-cell," engineered to specifically target B-cell maturation antigen (BCMA) protein. The patient's own T-lymphocytes are genetically modified ex vivo to express receptors capable of binding to BCMA protein expressed on the surface of malignant cells. These CAR T-cells are then expanded and infused back into each patient for the treatment of relapsed or refractory multiple myeloma.
Previous clinical research has demonstrated promising outcomes in the treatment of multiple myeloma with CAR T-cell therapy. For example, a clinical trial conducted by Bluebird Bio in 128 patients reported an overall response rate of 73% and a complete response rate of 33%, leading to approval by the United States Food and Drug Administration (FDA) in March 2021. Additionally, a clinical trial by Nanjing Legend Biotech in China, evaluating the investigational CAR T-cell product LCAR-B38M in 97 patients, demonstrated an overall response rate of 97.9% and a complete response rate of 80.4%.
The investigational product used in the current study has previously undergone a Phase 1 clinical trial in 15 patients with relapsed or refractory multiple myeloma, evaluating three dose levels: low (0.25 × 10⁷ cells/kg body weight), intermediate (0.5 × 10⁷ cells/kg body weight), and high (0.75 × 10⁷ cells/kg body weight). The study demonstrated an overall response rate of 100% and a complete response rate of 66.7%. Furthermore, patients who had previously received anti-CD38 monoclonal antibody immunotherapy and/or those with extramedullary disease also achieved an overall response rate of 100%.
Regarding safety, the most notable adverse event associated with BCMA-directed CAR T-cell gene therapy was cytokine release syndrome (CRS), which was observed in all patients and tended to be more severe in the high-dose cohort. However, all adverse events were manageable and clinically controllable. No treatment-related study discontinuations or deaths were reported.
Based on the efficacy and safety data, the high dose level (0.75 × 10⁷ cells/kg) was found to be associated with dose-limiting toxicity. Therefore, the intermediate dose (0.5 × 10⁷ cells/kg) - which demonstrated favorable therapeutic efficacy with an acceptable safety profile - was selected for the Phase 1b clinical trial in Thailand, in order to maximize benefit while minimizing risk to participants.
For the aforementioned reasons, this research project aims to further evaluate the safety and efficacy of BCMA-targeted CAR T-cell therapy in Thai patients with relapsed or refractory multiple myeloma. This Phase 1b study represents the first-in-Thai-patient clinical investigation of this approach. The research team anticipates that this therapy will demonstrate a high safety profile and effective disease control in patients with relapsed or refractory multiple myeloma.
- Being tested
- Chimeric Antigen Receptor T Cells (CAR-T)
- Keywords
- Relapsed/Refractory Multiple Myeloma, CART-BCMA, BCMA, CAR T-cell
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chimeric Antigen Receptor T Cells (CAR-T)Biological
This product is a CAR T-cell therapy utilizing the participant's own autologous T-lymphocytes, which are collected via apheresis, processed in a laboratory setting, and subsequently reinfused intravenously through a peripheral vein at a rate of 2-5 mL/min. Participants will undergo cell collection via apheresis for product preparation, followed by lymphodepleting chemotherapy. This process includes pre-chemotherapy and pre-infusion assessments prior to the administration of CART-BCMA cells.
| Study group | Role | What they receive |
|---|---|---|
| CART-BCMA in multiple myeloma | Experimental | Chimeric antigen receptor T-cell injection targeting BCMA (CART-BCMA) Dose level: 0.5×10e7 cells/Kg Receives: Biological: Chimeric Antigen Receptor T Cells (CAR-T) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety of CART-BCMA in patients with relapsed or refractory multiple myeloma.
Number and percentage of participants experiencing treatment-emergent adverse events (AEs) and serious adverse events (SAEs) after CART-BCMA cell infusion. AEs will be graded according to CTCAE version 5.0
Measured: Day 1 to Day 8, Day 14, Day 21, Day 28, Day 60, Day 90, Day 120, Day 180, Day 270, Day 360, and every 90 days from Day 450 to Day 720 after CART-BCMA cell infusion
Incidence of Dose-Limiting Toxicities (DLTs)
Number and percentage of participants experiencing dose-limiting toxicities (DLTs) during the DLT evaluation period following CART-BCMA cell infusion. DLTs will be defined according to protocol-specified criteria and graded using Common Terminology Criteria for Adverse Events (CTCAE), version 5.0
Measured: From Day 1 to Day 28 after CART-BCMA cell infusion (DLT evaluation period)
Secondary outcomes (7)
The overall response rate (ORR, at least PR or better) per IMWG 2016 Criteria
Percentage of participants achieving at least Partial Response (PR) or better (PR, VGPR, CR, or sCR) as assessed according to the International Myeloma Working Group (IMWG) 2016 response criteria.
Measured: Day 28, Day 60, Day 90, Day 120, Day 180, Day 270, Day 360, and every 90 days from Day 450 to Day 720 after CART-BCMA cell infusion
Complete Response (CR) or Stringent Complete Response (sCR) Rate per IMWG 2016 Criteria
Percentage of participants achieving Complete Response (CR) or Stringent Complete Response (sCR) according to IMWG 2016 criteria.
Measured: Day 28, Day 60, Day 90, Day 120, Day 180, Day 270, Day 360, and every 90 days from Day 450 to Day 720 after CART-BCMA cell infusion
Very Good Partial Response (VGPR) or Better Rate per IMWG 2016 Criteria
Percentage of participants achieving VGPR or better (VGPR, CR, or sCR) according to IMWG 2016 criteria.
Measured: Day 28, Day 60, Day 90, Day 120, Day 180, Day 270, Day 360, and every 90 days from Day 450 to Day 720 after CART-BCMA cell infusion
Time to First Documented Response (≥PR) per IMWG 2016 Criteria
Time from CART-BCMA cell infusion to first documented response of PR or better according to IMWG 2016 criteria.
Measured: From infusion date up to Day 720 (approximately 24 months)
Duration of Response per IMWG 2016 Criteria
Time from first documented response (≥PR) to disease progression or death from any cause, whichever occurs first, according to IMWG 2016 criteria.
Measured: From first documented response up to Day 720 (approximately 24 months)
Progression-Free Survival per IMWG 2016 Criteria
Time from CART-BCMA cell infusion to first documented disease progression or death from any cause, whichever occurs first, as defined by IMWG 2016 criteria.
Measured: From infusion date up to Day 720 (approximately 24 months)
Overall Survival (OS)
Time from CART-BCMA cell infusion to death from any cause.
Measured: From infusion date up to Day 720 (approximately 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Multiple Myeloma (MM)Studies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The optimal dose of investigational drug CART BCMA in the phase I trial, 0.5×107 CAR-Positive T cells/kg (body weight), was selected as the fixed dose for this trial.
- Masking
- None (open label)
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Collaborators
- King Chulalongkorn Memorial Hospital
- Responsible party
- Sponsor
- Investigators
- Kritsada Wuttigorn, Associate Professor, MD, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07458659
- Sponsor's protocol ID
- TTCI-BCMA-MM-P1b-2026
- Acronym
- CART-BCMA
- Status last verified
- Mar 2026
- First submitted
- 26 Feb 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib Clinical Study of BCMA-Targeted Chimeric Antigen Receptor T-Cell Injection (CART-BCMA) in the Treatment of Patients With Relapsed/Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT07458659
- Acronym / sponsor ID
- CART-BCMA / TTCI-BCMA-MM-P1b-2026
- Keywords
- Relapsed/Refractory Multiple Myeloma, CART-BCMA, BCMA, CAR T-cell
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Collaborators
- King Chulalongkorn Memorial Hospital
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 9 Mar 2026 (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.
A Phase 1b clinical trial to evaluate the safety and efficacy of BCMA-targeted CAR T-cell therapy in Thai patients with relapsed or refractory multiple myeloma.
Detailed description
The investigational product used in this study is a chimeric antigen receptor T-cell, also known as "CAR T-cell," engineered to specifically target B-cell maturation antigen (BCMA) protein. The patient's own T-lymphocytes are genetically modified ex vivo to express receptors capable of binding to BCMA protein expressed on the surface of malignant cells. These CAR T-cells are then expanded and infused back into each patient for the treatment of relapsed or refractory multiple myeloma.
Previous clinical research has demonstrated promising outcomes in the treatment of multiple myeloma with CAR T-cell therapy. For example, a clinical trial conducted by Bluebird Bio in 128 patients reported an overall response rate of 73% and a complete response rate of 33%, leading to approval by the United States Food and Drug Administration (FDA) in March 2021. Additionally, a clinical trial by Nanjing Legend Biotech in China, evaluating the investigational CAR T-cell product LCAR-B38M in 97 patients, demonstrated an overall response rate of 97.9% and a complete response rate of 80.4%.
The investigational product used in the current study has previously undergone a Phase 1 clinical trial in 15 patients with relapsed or refractory multiple myeloma, evaluating three dose levels: low (0.25 × 10⁷ cells/kg body weight), intermediate (0.5 × 10⁷ cells/kg body weight), and high (0.75 × 10⁷ cells/kg body weight). The study demonstrated an overall response rate of 100% and a complete response rate of 66.7%. Furthermore, patients who had previously received anti-CD38 monoclonal antibody immunotherapy and/or those with extramedullary disease also achieved an overall response rate of 100%.
Regarding safety, the most notable adverse event associated with BCMA-directed CAR T-cell gene therapy was cytokine release syndrome (CRS), which was observed in all patients and tended to be more severe in the high-dose cohort. However, all adverse events were manageable and clinically controllable. No treatment-related study discontinuations or deaths were reported.
Based on the efficacy and safety data, the high dose level (0.75 × 10⁷ cells/kg) was found to be associated with dose-limiting toxicity. Therefore, the intermediate dose (0.5 × 10⁷ cells/kg) - which demonstrated favorable therapeutic efficacy with an acceptable safety profile - was selected for the Phase 1b clinical trial in Thailand, in order to maximize benefit while minimizing risk to participants.
For the aforementioned reasons, this research project aims to further evaluate the safety and efficacy of BCMA-targeted CAR T-cell therapy in Thai patients with relapsed or refractory multiple myeloma. This Phase 1b study represents the first-in-Thai-patient clinical investigation of this approach. The research team anticipates that this therapy will demonstrate a high safety profile and effective disease control in patients with relapsed or refractory multiple myeloma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The optimal dose of investigational drug CART BCMA in the phase I trial, 0.5×107 CAR-Positive T cells/kg (body weight), was selected as the fixed dose for this trial.
| Arm | Type | Receives |
|---|---|---|
| CART-BCMA in multiple myeloma | Experimental | Biological: Chimeric Antigen Receptor T Cells (CAR-T)Chimeric antigen receptor T-cell injection targeting BCMA (CART-BCMA) Dose level: 0.5×10e7 cells/Kg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Age above 18 years old (inclusive), regardless of gender.
- Patients with multiple myeloma who have received at least three lines of treatment for multiple myeloma and have failed at least after treatment with proteasome inhibitors and immunomodulators; At least one complete cycle of each line of therapy, unless the best response to that therapy was documented as progressive disease (PD) (according to the 2016 published IMWG criteria for efficacy evaluation, Appendix 4); Patients must have PD records during or within 12 months after the last treatment or no response (no MR or better response) within 60 days after the last treatment.
- The presence of measurable lesions at screening was defined as any of the following:
- ECOG Performance Status (Appendix 1) of 0-1.
- Expected survival time ≥ 3 months.
Key exclusion criteria (32 listed)
- Subjects with a known history of allergy, hypersensitivity, intolerance, or contraindication to any component of CART-BCMA or drugs that may be used in the study (including fludarabine, cyclophosphamide, tocilizumab); or subjects allergic to beta-lactam antibiotics; or subjects with a history of severe allergic reactions.
- Subjects who have previously received any CAR-T therapy or BCMA-targeted therapy.
- Subjects who have received the following anti-multiple myeloma (anti-MM) treatments within the specified time frame before apheresis:
- Subjects who have received any investigational drug within 4 weeks prior to apheresis or are concurrently participating in another clinical study (except for the following: subjects participating in observational, non-interventional clinical studies, or those in the follow-up period of an interventional clinical study).
- Patients who have received autologous hematopoietic stem cell transplantation (ASCT) within 12 weeks prior to apheresis or have previously received allogeneic stem cell transplantation (with no time limit).
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 |
|---|---|---|
| Chimeric Antigen Receptor T Cells (CAR-T)This product is a CAR T-cell therapy utilizing the participant's own autologous T-lymphocytes, which are collected via apheresis, processed in a laboratory setting, and subsequently reinfused intravenously through a peripheral vein at a rate of 2-5 mL/min. Participants will undergo cell collection via apheresis for product preparation, followed by lymphodepleting chemotherapy. This process includes pre-chemotherapy and pre-infusion assessments prior to the administration of CART-BCMA cells. | Biological | CART-BCMA in multiple myeloma |
Primary outcome
The safety of CART-BCMA in patients with relapsed or refractory multiple myeloma.
Time frame: Day 1 to Day 8, Day 14, Day 21, Day 28, Day 60, Day 90, Day 120, Day 180, Day 270, Day 360, and every 90 days from Day 450 to Day 720 after CART-BCMA cell infusion
Number and percentage of participants experiencing treatment-emergent adverse events (AEs) and serious adverse events (SAEs) after CART-BCMA cell infusion. AEs will be graded according to CTCAE version 5.0
Incidence of Dose-Limiting Toxicities (DLTs)
Time frame: From Day 1 to Day 28 after CART-BCMA cell infusion (DLT evaluation period)
Number and percentage of participants experiencing dose-limiting toxicities (DLTs) during the DLT evaluation period following CART-BCMA cell infusion. DLTs will be defined according to protocol-specified criteria and graded using Common Terminology Criteria for Adverse Events (CTCAE), version 5.0
7 secondary outcomes
The overall response rate (ORR, at least PR or better) per IMWG 2016 Criteria
Time frame: Day 28, Day 60, Day 90, Day 120, Day 180, Day 270, Day 360, and every 90 days from Day 450 to Day 720 after CART-BCMA cell infusion
Complete Response (CR) or Stringent Complete Response (sCR) Rate per IMWG 2016 Criteria
Time frame: Day 28, Day 60, Day 90, Day 120, Day 180, Day 270, Day 360, and every 90 days from Day 450 to Day 720 after CART-BCMA cell infusion
Very Good Partial Response (VGPR) or Better Rate per IMWG 2016 Criteria
Time frame: Day 28, Day 60, Day 90, Day 120, Day 180, Day 270, Day 360, and every 90 days from Day 450 to Day 720 after CART-BCMA cell infusion
Time to First Documented Response (≥PR) per IMWG 2016 Criteria
Time frame: From infusion date up to Day 720 (approximately 24 months)
Duration of Response per IMWG 2016 Criteria
Time frame: From first documented response up to Day 720 (approximately 24 months)
Progression-Free Survival per IMWG 2016 Criteria
Time frame: From infusion date up to Day 720 (approximately 24 months)
Overall Survival (OS)
Time frame: From infusion date up to Day 720 (approximately 24 months)
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 9 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Kritsada Wuttigorn, Associate Professor, MD principal investigator
Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Chimeric Antigen Receptor T Cells (CAR-T) in people with Relapsed/Refractory Multiple Myeloma (MM), run by Chulalongkorn University at 1 site in Thailand.
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 23 inclusion and 32 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 9 Mar 2026. 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 Thailand. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Kritsada Wuttigorn, Associate Professor, MD (+66805623592, kitsada.w@chula.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The safety of CART-BCMA in patients with relapsed or refractory multiple myeloma. (time frame: Day 1 to Day 8, Day 14, Day 21, Day 28, Day 60, Day 90, Day 120, Day 180, Day 270, Day 360, and every 90 days from Day 450 to Day 720 after CART-BCMA cell 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 9 Mar 2026.