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

NCT07489534 | Recruiting Phase 2 DMC

• 1 other identifier: S2025-670-01
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Myeloma

Keywords

multiple myeloma; renal dysfunction; CART; fusion protein; consolidation therapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• overall survival (OS)

  2 years after treatment

• progression free survival (PFS)

  2 years after treatment

• time to progression (TTP)

  2 years after treatment

• disease free survival (DFS)

  2 years after treatment

• duration of response (DOR)

  2 years after treatment

Study Arms (1)

multiple myeloma patients with renal dysfunction who accept PD- 1Ab21-BCMA CAR-T cell immunotherapy

EXPERIMENTAL

Drug: PD-1Ab21-BCMA CAR-T cell immunotherapy

Interventions

PD-1Ab21-BCMA CAR-T cell immunotherapy DRUG

Consolidation therapy with PD-1 antibody and BCMA-targeting CAR-T in multiple myeloma patients with renal impairment.

multiple myeloma patients with renal dysfunction who accept PD- 1Ab21-BCMA CAR-T cell immunotherapy

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: Over 14 years old
• 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.
• The hospital examination meets the following indicators:
• ECOG physical status score 0-2 or KPS score\>80 points
• Having sufficient venous access for single or intravenous blood collection, and no other blood cells Separation contraindications
• WBC≥1×109/L，LY≥0.3×109/L，
• ALT and AST ≤ 2.5 ULN
• Serum total bilirubin ≤ 2.0mg/dL (34.2 μmol/L)
• PT:INR\<1.7 or PT prolonged by\<4s compared to normal value

You may not qualify if:

• 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);
• Any uncontrollable active infection;
• Presence of active hepatitis B or C virus infection;
• HIV/AIDS infection;
• Has neurological disorders;
• Within 2 weeks prior to signing the informed consent form, systemic use of steroid drugs (inhalable steroids may be used);
• Allergies to immunotherapy and related drugs;
• Currently, there are patients with heart disease or poorly controlled hypertension who require treatment;
• Currently, patients with unstable or active ulcers or gastrointestinal bleeding;
• Patients with a history of organ transplantation or waiting for organ transplantation;
• Hyponatremia, blood sodium\<125mmol/L;
• Baseline blood potassium\<3.5mmol/L (potassium can be supplemented before participating in the study to restore blood potassium levels above this level);
• The patient needs anticoagulant therapy (such as warfarin or heparin);
• The patient requires long-term antiplatelet therapy (aspirin, dose\>300mg/d); Clopidogrel, dose\>75mg/d).
• Additionally,

Sponsors & Collaborators

• Daihong Liu: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma; Renal Insufficiency

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; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Li-Ping Dou, Dr.

CONTACT

86-010-66937232; lipingruirui@163.com

Study Design

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

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 24, 2026
• Study Start: September 29, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: March 24, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)