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Study of PD-1Ab21-BCMA CAR-T Therapy for Consolidation of Multiple Myelomawith Renal Dysfunction Phase 2 25 Immuntherapie

Offene Rekrutierung
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT07489534 untersucht Behandlung im Zusammenhang mit Multiples Myelom. Diese interventionsstudie der Phase 2 hat den Status offene rekrutierung und startete am 29. September 2025. Es ist geplant, 25 Teilnehmer aufzunehmen. Durchgeführt von Daihong Liu wird der Abschluss für 31. Juli 2027 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 24. März 2026 aktualisiert.
Kurzbeschreibung
The purpose of this study is to determine the efficacy and safety of targeted BCMA CART cells secreting PD1 and interleukin 21 fusion protein immunotherapy for first-line consolidation therapy of multiple myeloma with renal dysfunction.
Ausführliche Beschreibung
Renal dysfunction is a poor prognostic factor for multiple myeloma（MM）. Compared with MM patients with normal renal function, MM patients with renal dysfunction have significantly reduced median overall survival. The clinical outcomes of MM patients with improved renal function after treatment have shown some improvement, but are still inferior to those of MM patients with normal renal function. Although renal dysfun...Mehr anzeigen
Offizieller Titel

Exploratory Clinical Study on PD-1Ab21-BCMA CAR-T Cells (CD203) for First-line Consolidation Therapy of Multiple Myeloma With Renal Dysfunction

Erkrankungen
Multiples Myelom
Weitere Studien-IDs
  • S2025-670-01
NCT-Nummer
NCT07489534
Studienbeginn (tatsächlich)
2025-09-29
Zuletzt aktualisiert
2026-03-24
Studienende (vorauss.)
2027-07-31
Geplante Rekrutierung
25
Studientyp
Interventionsstudie
PHASE
Phase 2
Status
Offene Rekrutierung
Stichwörter
multiple myeloma; renal dysfunction; CART; fusion protein; consolidation therapy
Primäres Ziel
Behandlung
Zuteilungsmethode
Nicht zutreffend
Interventionsmodell
Einarmige Studie
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
Experimentellmultiple myeloma patients with renal dysfunction who accept PD- 1Ab21-BCMA CAR-T cell immunotherapy
PD-1Ab21-BCMA CAR-T cell immunotherapy
Consolidation therapy with PD-1 antibody and BCMA-targeting CAR-T in multiple myeloma patients with renal impairment.
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
1-year progression free survival rate (1-year-PFS)
The 1-year progression free survival rate (1-year-PFSR) of PD-1Ab21-BCMA CAR-T cell immunotherapy for first-line consolidation therapy of multiple myeloma with renal dysfunction refers to the proportion of disease progression that occurs within one year after treatment in patients.
1 year after treatment
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
overall survival (OS)
Overall survival (OS) refers to the time from the start of treatment to the death of the patient for any reason.
2 years after treatment
progression free survival (PFS)
Progression free survival (PFS) refers to the time from treatment to the first myeloma progression or death of the patient for any reason.
2 years after treatment
time to progression (TTP)
Time to progression (TTP) refers to the time from treatment to the first myeloma progression.
2 years after treatment
disease free survival (DFS)
Disease free survival (DFS) refers to the time from treatment to the first myeloma recurrence.
2 years after treatment
duration of response (DOR)
Duration of Response (DOR) refers to the time from the first assessment of a myeloma as a complete or partial response to the first assessment of PD (Progressive Disease) or death from any cause.
2 years after treatment
event free survival (EFS)
Event Free Survival (EFS) is a commonly used endpoint indicator in clinical trials to evaluate the survival time of patients without any adverse events during a specific time period. These adverse events include but are not limited to disease progression, death, treatment plan changes, and the occurrence of serious side effects.
2 years after treatment
recurrence rate
The recurrence rate refers to the proportion of patients with lymphoma recurrence after treatment.
2 years after treatment
safety
The safety of this PD-1Ab21-BCMA CAR-T immunotherapy.
2 years after treatment
Teilnahme-Assistent
Eignungskriterien

Zugelassene Altersgruppen
Kind, Erwachsene, Ältere Erwachsene
Mindestalter
14 Years
Zugelassene Geschlechter
Alle

  1. Age: Over 14 years old

  2. Diagnosed with multiple myeloma accompanied by renal dysfunction, received ≥ 2 courses of clinical first-line treatment, evaluated efficacy above PR, and predicted survival of more than three months.

  3. The hospital examination meets the following indicators:

    1. ECOG physical status score 0-2 or KPS score>80 points
    2. Having sufficient venous access for single or intravenous blood collection, and no other blood cells Separation contraindications
    3. WBC≥1×109/L，LY≥0.3×109/L，
    4. ALT and AST ≤ 2.5 ULN
    5. Serum total bilirubin ≤ 2.0mg/dL (34.2 μmol/L)
    6. PT:INR<1.7 or PT prolonged by<4s compared to normal value

  1. Pregnant or lactating women (the safety of this treatment for unborn babies is unknown, and the assessment of pregnancy status for female participants is negative in serum or urine pregnancy tests within 48 hours prior to infusion);
  2. Any uncontrollable active infection;
  3. Presence of active hepatitis B or C virus infection;
  4. HIV/AIDS infection;
  5. Has neurological disorders;
  6. Within 2 weeks prior to signing the informed consent form, systemic use of steroid drugs (inhalable steroids may be used);
  7. Allergies to immunotherapy and related drugs;
  8. Currently, there are patients with heart disease or poorly controlled hypertension who require treatment;
  9. Currently, patients with unstable or active ulcers or gastrointestinal bleeding;
  10. Patients with a history of organ transplantation or waiting for organ transplantation;
  11. Hyponatremia, blood sodium<125mmol/L;
  12. Baseline blood potassium<3.5mmol/L (potassium can be supplemented before participating in the study to restore blood potassium levels above this level);
  13. The patient needs anticoagulant therapy (such as warfarin or heparin);
  14. The patient requires long-term antiplatelet therapy (aspirin, dose>300mg/d); Clopidogrel, dose>75mg/d).

Additionally,

  1. Patients currently participating in other clinical trials;
  2. Researchers believe that other reasons are not suitable for clinical trial participants.
Daihong Liu logoDaihong Liu
Verantwortliche Partei
Daihong Liu, Prüfsponsor, Dr., Chinese PLA General Hospital
Zentrale Studienkontakte
Kontakt: Li-Ping Dou, Dr., 86-010-66937232, [email protected]
1 Studienstandorte in 1 Ländern

Beijing Municipality

Chinese PLA General Hospital, Beijing, Beijing Municipality, 100853, China
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