Chimeric Antigen Receptor Modified T Cells Targeting BCMA for the Treatment of Relapsed/Refractory Multiple Myeloma

NCT06581640 | Recruiting Phase 2

• 1 other identifier: XMDYYYXYK-11
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and tolerability of chimeric antigen receptor gene-modified T cells targeting BCMA for the treatment of relapsed/refractory multiple myeloma

Conditions

Multiple Myeloma; Relapsed/Refractory

Outcome Measures

Primary Outcomes (1)

• Complete remission rate (CR)

  Negative serum and urine immunofixation electrophoresis, disappearance of soft tissue plasmacytoma, and less than 5% plasma cells in the bone marrow. For patients who rely solely on serum FLC levels as a measurable lesion, in addition to meeting the above CR criteria, it is also required that the ratio of serum FLC is restored to normal in two consecutive evaluations.

  Up to 36 months

Secondary Outcomes (1)

• Adverse events (AE)

  Up to 36 months

Study Arms (1)

CAR-T

EXPERIMENTAL

Biological: CAR-T treatment

Interventions

CAR-T treatment BIOLOGICAL

Peripheral blood lymphocyte collection, PBMC separation, BCMA CAR-T cell preparation/storage, lymphodepletion chemotherapy pretreatment for the subject, and BCMA CAR-T cell infusion.

CAR-T

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years, no gender restrictions;
• Diagnosed with refractory/relapsed multiple myeloma through physical examination, pathological examination, laboratory tests, and imaging studies;
• Flow cytometry or histology confirms positive BCMA expression in myeloma cells;
• As judged by the investigator, the expected survival time is \>3 months;
• ECOG performance status score ≤2, KPS \>60%;
• The patient has good liver, kidney, heart, and lung function: ALT and AST ≤2.5×ULN, those with liver involvement can be relaxed to ≤5×ULN; serum total bilirubin \<34 μmol/L; creatinine clearance rate \>30 mL/min; heart ejection fraction (EF) ≥40%, no pericardial effusion and significant arrhythmia; indoor SpO2 ≥92%;
• Peripheral blood lymphocyte absolute count ALC ≥0.5 ×10\^9/L, PLT \>30×10\^9/L, Hb \>80 g/L and has a single collection venous access, and there are no other contraindications for hematopoietic cell separation;
• Those with fertility must agree to use highly effective contraceptive methods;
• The subject or their legal guardian can understand and is willing to sign a written informed consent form voluntarily.

You may not qualify if:

• Pregnant or nursing women, as well as women planning to become pregnant within the next six months;
• Positive virology tests for hepatitis B, hepatitis C, HIV, syphilis, or cytomegalovirus;
• History of other tumors (except for those with skin or cervical in situ cancers that have been cured by radical treatment and show no evidence of disease activity);
• Previously received treatment targeting BCMA;
• Underwent autologous hematopoietic stem cell transplantation within the last 6 weeks;
• Presence of uncontrolled active bacterial or fungal infection;
• Allergic to research-related drugs or cell components;
• Presence of active autoimmune diseases;
• Currently have unstable or active ulcers or gastrointestinal bleeding;
• Unable to cooperate with treatment and efficacy evaluation due to mental or psychological disorders;
• Received other experimental drug treatments within the last 3 months;
• The researcher believes that for other reasons, the individual is not suitable for the clinical trial.

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University: lead

Study Sites (1)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361000, China

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma; Recurrence

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; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bing Xu

  The First Aiffiliated hosptical of xiamen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bing Xu

CONTACT

18750918842; xubingzhangjian@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 30, 2024
• First Posted: September 3, 2024
• Study Start: September 24, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 25, 2024

Record last verified: 2024-08

Locations

CN (1)