Relapsed/Refractory Multiple MyelomaPhase 1NCT06655519
An Exploratory Study of RD140 Injection in Patients With Relapsed/Refractory Multiple Myeloma or Plasma Cell Leukemia
A Phase 1 study testing CAR-T（RD140 injection） in people with Relapsed/Refractory Multiple Myeloma and Plasma Cell Leukemia, run by Peking University People's Hospital.
Trial summary
This is a single-center, open clinical study, divided into two phases of dose escalation and dose expansion, to observe the safety and efficacy of RD140 injection at different doses in patients with relapsed/refractory multiple myeloma or plasmacytic leukemia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Relapsed/Refractory Multiple Myeloma, Plasma Cell Leukemia
- What is being tested?
- CAR-T（RD140 injection）
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 25 Oct 2024to 5 Jul 2041
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 75 years old, male or female;
- Diagnosed as Multiple Myeloma (MM) according to the international standard for multiple myeloma (IMWG), or diagnosed as primary plasma cell leukemia;
- Subjects have had at least 3 prior lines of therapy including at least one proteasome inhibitor (PI), one immunomodulatory agent (IMiD), and one anti-CD38 monoclonal antibody, or subjects who were refractory to the above treatments.
- Disease progression must be documented during or within 12 months following the most recent anti-tumor treatment (the progression for subjects whose last line treatment was CAR-T therapy was not limited to 12 months post-treatment);
- Presence of measurable lesion at screening as determined by any of the following criteria for subjects with MM:
- Serum M protein level: IgG type M protein ≥ 10 g/L, or IgA, IgD, IgE, IgM type M protein ≥ 5 g/L;
Show all 21Show fewer
- Urine M protein level ≥ 200 mg/24h;
- Light chain multiple myeloma without measurable M protein in serum or urine: Involved serum free light chain (sFLC) ≥ 100 mg/L and abnormal serum κ/λ free light chain ratio；
- Serum M- protein, urine M- protein, or involved sFLC not meeting above criteria but bone marrow plasma cell percentage ≥30%;
- Subjects with primary plasma cell leukemia: peripheral blood plasma cell percentage≥5%at screening;
- ECOG score of 0 or 1;
- Estimated life expectancy ≥12 weeks;
- Subjects must have adequate organ function and meet all of the following laboratory test results prior to enrollment:
- Blood routine: absolute neutrophil count (ANC) ≥ 1×10^9/L (support with growth factor is allowed, but must not have received support treatment within 7 days before the laboratory test); Absolutely lymphocyte count (ALC) ≥0.3×10^9/L; Platelets ≥50×10^9/L (must not have received platelet transfusion support within 7 days before the laboratory test); Hemoglobin ≥60 g/L(must not have received red blood cell [RBC] transfusion within 7 days before the laboratory test);
- Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤2.5× Upper limit of normal value (ULN); Serum total bilirubin ≤1.5 ×ULN;
- Renal function: creatinine clearance (CrCl) calculated by Cockcroft-Gault formula ≥ 40 ml/min;
- Coagulation function: fibrinogen ≥ 1.0g /L; Activated partial thromboplastin time (aPTT) ≤1.5× ULN, Pro thrombin time (PT) ≤1.5× ULN;
- Blood oxygen saturation(SaO2) >91%;
- Left ventricular ejection fraction (LVEF) ≥ 50%;
- Subjects agree to take effective measures or drug contraceptive measures (excluding safe period contraception) after signing the ICF and within one year after CAR-T cell infusion;
- Subjects must sign an informed consent approved by the Ethics Committee before starting any screening procedures.
Who cannot join
- Subjects who are known to have Graft-Versus-host disease (GVHD) or need long-term immunosuppressive therapy;
- Subjects have received an autologous hematopoietic stem cell transplantation (auto-HSCT) within 12 weeks before leukapheresis or have a previous history of two times of auto-HSCT or previous history of an allogeneic hematopoietic stem cell transplantation (allo-HSCT);
- Received targeted plasma cell therapy within 3 months before leukapheresis, or previous cell therapy products can still be detected in peripheral blood.
- Subjects have received any anti-tumor treatment as follows, prior to leukapheresis:
- Monoclonal antibody for multiple myeloma or plasma cell leukemia within 21 days, or;
- Cytotoxic chemotherapy or proteasome inhibitors within 14 days, or;
Show all 22Show fewer
- Immunomodulators within 7 days, or;
- Received other anti-cancer therapy within 14 days or at least 5 half-lives
- Subjects require long-term use of glucocorticoids (defined as prednisone or equivalent > 20 mg/day) at a therapeutic dose during the study, physiologic replacement, topical, and inhaled steroids are permitted, nevertheless.
- Subjects with hypertension that cannot be controlled by medication;
- Sever cardiac disease including but not limited to unstable angina pectoris, myocardial infarction (within 6 months prior to screening), cardiac failure congestive (New York Heart Association [NYHA] class ≥ III), severe arrhythmia;
- Unstable systemic disease as judged by the investigator: including but not limited to severe liver, renal, or metabolic disease requiring drug therapy ;
- Subjects has prior history of malignancies, other than MM and plasma cell leukemia within 5 years before screening, with the exception of radical carcinoma in situ of the cervix, basal cell carcinoma or squamous cell carcinoma of skin, localized cancer of prostate after radical prostatectomy, ductal carcinoma in situ of breast after radical mastectomy, or papillary thyroid carcinoma after radical thyroidectomy;
- Subjects with a history of organ transplantation;
- Subjects with suspected or known central nervous system (CNS) involvement with myeloma;
- Subjects with history of major surgery within 2 weeks prior to leukapheresis or planned to have surgery within 2 weeks after study treatment (except for subjects who were planned to have local anesthesia);
- Treated with other investigational products within 1 month prior to leukapheresis;
- Subjects have uncontrolled systemic fungal, bacterial, viral or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antimicrobial treatment) or requiring IV antimicrobials for management;
- 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; Syphilis toluidine red unheated serum test (TRUST) and treponemal particle agglutination test (TPPA) were positive;
- Pregnant or breastfeeding women;
- Subjects have psychiatric disorders, conscious disorders, or central nervous system diseases;
- Any condition for which, at the discretion of investigators, participation would not be in the best interest of the subject.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Exploratory Study of Fully Human Anti-B-Cell Maturation Antigen (BCMA)/G Protein-coupled Receptor, Class C Group 5 Member (GPRC5D) Chimeric Antigen Receptor T Cells (RD140) in Patients With Relapsed/Refractory Multiple Myeloma or Plasma Cell Leukemia
This is a single-center, open clinical study, divided into two phases of dose escalation and dose expansion, to observe the safety and efficacy of RD140 injection at different doses in patients with relapsed/refractory multiple myeloma or plasmacytic leukemia.
Read the detailed description
This study is divided into two stages: dose escalation and dose extension. The "3+3" dose escalation design was adopted in the dose escalation stage, and three dose escalation dose groups of 1.0×10^5 CART(Chimeric Antigen Receptor T Cell) cells/kg, 3.0×10^5 CART cells/kg and 6.0×10^5 CART cells/kg were preset. Each dose group level included 3-6 subjects with a single dose. The objective is to preliminarily observe the safety and tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of RD140 injection at different doses in patients with relapsed/refractory multiple myeloma (RRMM) or plasma cell leukemia, and provide evidence for dose expansion phase.
In the dose expansion phase, 1 to 2 dose groups were selected for expansion based on the dose escalation phase, and 3 to 6 subjects were included in each extended dose group to further evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of RD140 injection in the treatment of RRMM or plasma cell leukemia.
- Being tested
- CAR-T（RD140 injection）
- Keywords
- Multiple Myeloma, Plasma Cell Leukemia, RD140
- Medical subject headings
- Multiple Myeloma, Leukemia, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR-T（RD140 injection）Biological
This study is divided into two stages: dose escalation and dose extension. The dose escalation stage sampled the "3+3" dose-escalation design, and set up three dose-increasing dose groups of 1.0×10^5 CART cells/kg, 3.0×10^5 CART cells/kg and 6.0×10^5 CART cells/kg, and subjects will receive a single infusion of RD140. Each dose group level will include 3-6 subjects.
In the dose expansion stage, 1~2 dose groups were selected for expansion and 3~6 subjects were included in each extended dose group, and the target dose was administered once.
| Study group | Role | What they receive |
|---|---|---|
| RD140 injection | Experimental | subjects will receive a single infusion of Fully Human Anti-BCMA/GPRC5D Chimeric Antigen Receptor T Cells with does of 1-6×10^5 CAR T cells/kg. Receives: Biological: CAR-T（RD140 injection） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Type and incidence of adverse events (AEs)
Measured: 2 years after CAR-T cell infusion
Secondary outcomes (15)
Overall response rate (ORR)
Proportion of subjects who achieved sCR, CR, VGPR, and PR after receiving study therapy
Measured: Up to 2 years post RD140 infusion
Duration of Response (DOR)
Time from first response to disease progression or death from any cause
Measured: Up to 2 years post RD140 infusion
Progression-free Survival (PFS)
Time from RD140 infusion to first documentation of progressive disease (PD), or death due to any cause, whichever occurs first
Measured: Up to 2 years post RD140 infusion
Overall Survival (OS)
Time from RD140 infusion to time of death due to any cause
Measured: Through study completion，up to 15 years post RD140 infusion
Time to Response (TTR)
Time from RD140 infusion to first documentation of response
Measured: Up to 2 years post RD140 infusion
Time to Complete Response (TTCR)
Time from RD140 infusion to first documentation of Complete Response or better response
Measured: Up to 2 years post RD140 infusion
Minimal Residual Disease (MRD)
Proportion of subjects who achieved MRD negative
Measured: Up to 2 years post RD140 infusion
Duration of MRD negativity
The time from the first MRD negative to the first MRD negative positive transfer
Measured: Up to 2 years post RD140 infusion
Pharmacokinetics - Cmax
The maximum transgene level at Tmax
Measured: Up to 2 years post RD140 infusion
Pharmacokinetics - Tmax
Time to peak transgene level
Measured: Up to 2 years post RD140 infusion
Pharmacokinetics - Area Under the Curve (AUC)
Area under the curve of 28, 90, 180 days and the last time point of PK detection (AUC0-28d, AUC0-90d, AUC0-180d, AUC0-last)
Measured: Up to 2 years post RD140 infusion
soluble BCMA levels
soluble BCMA levels in peripheral blood of subjects
Measured: Up to 2 years post RD140 infusion
C-reactive protein (CRP)
Changes in the levels of CRP
Measured: Up to 3 months post RD140 infusion
Ferritin
Changes in the levels of Ferritin
Measured: Up to 3 months post RD140 infusion
Interleukin-6 (IL-6)
Changes in the levels of IL-6
Measured: Up to 3 months post RD140 infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start25 Oct 2024 (estimated)
- Primary completion5 Jul 2028 (estimated)
- Study completion5 Jul 2041 (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 MyelomaStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe 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
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Lu, MD, Peking University People's Hospital
- Investigators
- Jin Lu, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06655519
- Sponsor's protocol ID
- RD140CI001
- Status last verified
- Oct 2024
- First submitted
- 17 Oct 2024
- Last updated
- 23 Oct 2024
- 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 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of Fully Human Anti-B-Cell Maturation Antigen (BCMA)/G Protein-coupled Receptor, Class C Group 5 Member (GPRC5D) Chimeric Antigen Receptor T Cells (RD140) in Patients With Relapsed/Refractory Multiple Myeloma or Plasma Cell Leukemia
- ClinicalTrials.gov ID
- NCT06655519
- Acronym / sponsor ID
- RD140CI001
- Keywords
- Multiple Myeloma, Plasma Cell Leukemia, RD140
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 25 Oct 2024 (estimated)
- Primary completion
- 5 Jul 2028 (estimated)
- Study completion
- 5 Jul 2041 (estimated)
- First posted
- 23 Oct 2024 (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 single-center, open clinical study, divided into two phases of dose escalation and dose expansion, to observe the safety and efficacy of RD140 injection at different doses in patients with relapsed/refractory multiple myeloma or plasmacytic leukemia.
Detailed description
This study is divided into two stages: dose escalation and dose extension. The "3+3" dose escalation design was adopted in the dose escalation stage, and three dose escalation dose groups of 1.0×10^5 CART(Chimeric Antigen Receptor T Cell) cells/kg, 3.0×10^5 CART cells/kg and 6.0×10^5 CART cells/kg were preset. Each dose group level included 3-6 subjects with a single dose. The objective is to preliminarily observe the safety and tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of RD140 injection at different doses in patients with relapsed/refractory multiple myeloma (RRMM) or plasma cell leukemia, and provide evidence for dose expansion phase.
In the dose expansion phase, 1 to 2 dose groups were selected for expansion based on the dose escalation phase, and 3 to 6 subjects were included in each extended dose group to further evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of RD140 injection in the treatment of RRMM or plasma cell leukemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RD140 injection | Experimental | Biological: CAR-T（RD140 injection）subjects will receive a single infusion of Fully Human Anti-BCMA/GPRC5D Chimeric Antigen Receptor T Cells with does of 1-6×10^5 CAR T cells/kg. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Age 18 to 75 years old, male or female;
- Diagnosed as Multiple Myeloma (MM) according to the international standard for multiple myeloma (IMWG), or diagnosed as primary plasma cell leukemia;
- Subjects have had at least 3 prior lines of therapy including at least one proteasome inhibitor (PI), one immunomodulatory agent (IMiD), and one anti-CD38 monoclonal antibody, or subjects who were refractory to the above treatments.
- Disease progression must be documented during or within 12 months following the most recent anti-tumor treatment (the progression for subjects whose last line treatment was CAR-T therapy was not limited to 12 months post-treatment);
- Presence of measurable lesion at screening as determined by any of the following criteria for subjects with MM:
Key exclusion criteria (22 listed)
- Subjects who are known to have Graft-Versus-host disease (GVHD) or need long-term immunosuppressive therapy;
- Subjects have received an autologous hematopoietic stem cell transplantation (auto-HSCT) within 12 weeks before leukapheresis or have a previous history of two times of auto-HSCT or previous history of an allogeneic hematopoietic stem cell transplantation (allo-HSCT);
- Received targeted plasma cell therapy within 3 months before leukapheresis, or previous cell therapy products can still be detected in peripheral blood.
- Subjects have received any anti-tumor treatment as follows, prior to leukapheresis:
- Subjects require long-term use of glucocorticoids (defined as prednisone or equivalent > 20 mg/day) at a therapeutic dose during the study, physiologic replacement, topical, and inhaled steroids are permitted, nevertheless.
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 |
|---|---|---|
| CAR-T（RD140 injection）This study is divided into two stages: dose escalation and dose extension. The dose escalation stage sampled the "3+3" dose-escalation design, and set up three dose-increasing dose groups of 1.0×10^5 CART cells/kg, 3.0×10^5 CART cells/kg and 6.0×10^5 CART cells/kg, and subjects will receive a single infusion of RD140. Each dose group level will include 3-6 subjects. In the dose expansion stage, 1~2 dose groups were selected for expansion and 3~6 subjects were included in each extended dose group, and the target dose was administered once. | Biological | RD140 injection |
Primary outcome
Adverse Events
Time frame: 2 years after CAR-T cell infusion
Type and incidence of adverse events (AEs)
15 secondary outcomes
Overall response rate (ORR)
Time frame: Up to 2 years post RD140 infusion
Duration of Response (DOR)
Time frame: Up to 2 years post RD140 infusion
Progression-free Survival (PFS)
Time frame: Up to 2 years post RD140 infusion
Overall Survival (OS)
Time frame: Through study completion，up to 15 years post RD140 infusion
Time to Response (TTR)
Time frame: Up to 2 years post RD140 infusion
Time to Complete Response (TTCR)
Time frame: Up to 2 years post RD140 infusion
Minimal Residual Disease (MRD)
Time frame: Up to 2 years post RD140 infusion
Duration of MRD negativity
Time frame: Up to 2 years post RD140 infusion
Pharmacokinetics - Cmax
Time frame: Up to 2 years post RD140 infusion
Pharmacokinetics - Tmax
Time frame: Up to 2 years post RD140 infusion
Pharmacokinetics - Area Under the Curve (AUC)
Time frame: Up to 2 years post RD140 infusion
soluble BCMA levels
Time frame: Up to 2 years post RD140 infusion
C-reactive protein (CRP)
Time frame: Up to 3 months post RD140 infusion
Ferritin
Time frame: Up to 3 months post RD140 infusion
Interleukin-6 (IL-6)
Time frame: Up to 3 months post RD140 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 23 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Relapsed/Refractory Multiple Myeloma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 3
A Trial to Learn How Well Linvoseltamab Works Compared to the Combination of Elotuzumab, Pomalidomide and Dexamethasone for Adult Participants With Relapsed/Refractory Multiple Myeloma
Relapsed Refractory Multiple Myeloma (RRMM)
RecruitingPhase 1/2
A Trial to Study if REGN17372 in Combination With Linvoseltamab is Tolerable for Adult Participants With Relapsed/Refractory Multiple Myeloma
Relapsed Refractory Multiple Myeloma (RRMM)
RecruitingPhase 1
A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Participants With Multiple Myeloma That is Resistant to Current Standard of Care Treatments
Multiple Myeloma
RecruitingPhase 1
A Study Evaluating the Safety, Pharmacokinetics, and Activity of the Combination of Cevostamab and Elranatamab in Participants With Relapsed or Refractory Multiple Myeloma (R/R MM)
Relapsed or Refractory Multiple Myeloma
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.
Jin Lu principal investigator
Peking University People's Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CAR-T（RD140 injection） in people with Relapsed/Refractory Multiple Myeloma and Plasma Cell Leukemia, run by Peking University People's Hospital.
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 21 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: opening soon, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Xuelin Dou (+86-010-86491512 ext. 7003, dxldw@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: 2 years after CAR-T cell infusion). 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 23 Oct 2024.