PD-1Ab21-BCMA CAR-T consolidation for multiple myeloma with renal dysfunction

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

This trial will test a BCMA-targeted CAR-T cell therapy that secretes a PD-1 antibody and interleukin-21 fusion protein as consolidation treatment for people with multiple myeloma who have kidney dysfunction.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 14 Years and up
• Sex: All
• Sponsor: Chinese PLA General Hospital (Academic / other)
• Drugs / interventions: immunotherapy, CART, CAR-T
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07489534 on ClinicalTrials.gov

What this trial studies

This is a phase 2, interventional trial of autologous BCMA-directed CAR-T cells engineered to secrete a PD-1 antibody and IL-21 fusion protein given as consolidation after first-line therapy in patients with multiple myeloma and renal dysfunction. Eligible participants are over 14 years old, have received at least two courses of first-line treatment with at least a partial response, and must meet defined performance status and laboratory criteria. Treatment involves leukapheresis to collect patient T cells, ex vivo manufacture of the PD-1Ab21-BCMA CAR-T product, and infusion with inpatient monitoring for safety and efficacy endpoints. The study will track hematologic responses, renal function changes, and treatment-related toxicities at the Chinese PLA General Hospital in Beijing.

Who should consider this trial

Good fit: People over 14 with multiple myeloma and renal dysfunction who have had at least two courses of first-line treatment, achieved ≥ partial response, have ECOG 0–2 (or KPS >80), adequate blood counts and organ function, and expected survival >3 months.

Not a fit: Patients with uncontrolled active infections, pregnant or breastfeeding women, those with insufficient blood counts or organ function outside the trial limits, or those with very limited life expectancy are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could deepen cancer responses, improve kidney function, and lower relapse risk after first-line therapy.

How similar studies have performed: Other BCMA-targeted CAR-T programs have shown high response rates and case series from Chinese centers report renal improvement after CAR-T, but the PD-1Ab21-secreting BCMA CAR-T construct is a novel variation with limited prior testing.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Where this trial is running

Beijing, Beijing Municipality

• Chinese PLA General Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Li-Ping Dou, Dr.

Conditions Multiple Myeloma; multiple myeloma; renal dysfunction; CART; fusion protein; consolidation therapy