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

ConditionMultiple Myeloma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age14+
SponsorDaihong Liu

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

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

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: multiple myeloma patients with renal dysfunction who accept PD- 1Ab21-BCMA CAR-T cell immunotherapyExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
1 year after treatment

Secondary outcomes

1

overall survival (OS)

Overall survival (OS) refers to the time from the start of treatment to the death of the patient for any reason.

Time frame
2 years after treatment
2

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.

Time frame
2 years after treatment
3

time to progression (TTP)

Time to progression (TTP) refers to the time from treatment to the first myeloma progression.

Time frame
2 years after treatment
4

disease free survival (DFS)

Disease free survival (DFS) refers to the time from treatment to the first myeloma recurrence.

Time frame
2 years after treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Daihong Liu

Lead sponsor

Chinese PLA General Hospital

Sponsor institution

Source ClinicalTrials.gov
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