An Exploratory Study of RD140 Injection in Patients With Relapsed/Refractory Multiple Myeloma or Plasma Cell Leukemia

NCT06655519 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: RD140CI001
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Relapsed/Refractory Multiple Myeloma; Plasma Cell Leukemia

Keywords

Multiple Myeloma; Plasma Cell Leukemia; RD140

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  Type and incidence of adverse events (AEs)

  2 years after CAR-T cell infusion

Secondary Outcomes (15)

• Overall response rate (ORR)

  Up to 2 years post RD140 infusion

• Duration of Response (DOR)

  Up to 2 years post RD140 infusion

• Progression-free Survival (PFS)

  Up to 2 years post RD140 infusion

• Overall Survival (OS)

  Through study completion，up to 15 years post RD140 infusion

• Time to Response (TTR)

  Up to 2 years post RD140 infusion

Other Outcomes (2)

• Immunogenicity

  Up to 2 years post RD140 infusion

• replication competent lentivirus (RCL)

  Through study completion，up to 15 years post RD140 infusion

Study Arms (1)

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.

Biological: CAR-T（RD140 injection）

Interventions

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.

RD140 injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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;

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Peking University People's Hospital: lead

MeSH Terms

Conditions

Multiple Myeloma; Leukemia, Plasma Cell

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Leukemia

Study Officials

• Jin Lu

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuelin Dou

CONTACT

+86-010-86491512; dxldw@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal of Investigator

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: October 23, 2024
• Study Start: October 25, 2024
• Primary Completion (Estimated): July 5, 2028
• Study Completion (Estimated): July 5, 2041
• Last Updated: October 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share