Health TrialsbyHealthPanel

In Vivo BCMA/GPRC5D Tandem Dual CAR-T Therapy for Relapsed/Refractory Plasma Cell Neoplasms

ConditionPlasma Cell Neoplasms
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorLiping Dou

About this trial

This study aims to assess the safety profile of in vivo BCMA/GPRC5D-targeted CAR-T cell immunotherapy in patients with relapsed or refractory plasma cell neoplasms.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntary signing of informed consent by the subject or legally authorized representative, with willingness and ability to comply with scheduled visits, study treatment, laboratory tests, and other study procedures.

Clonal plasma cells confirmed to be BCMA and/or GPRC5D positive by flow cytometry or immunohistochemistry;

Previously treated with at least 2 lines of anti-plasma cell neoplasms therapy, with at least 1 complete treatment cycle for each line, and evidence of disease progression within 12 months after the most recent anti-plasma cell neoplasms treatment, or being refractory to both immunomodulatory drugs and proteasome inhibitors, with disease progression within 2 months after the most recent anti-plasma cell neoplasms treatment (according to the IMWG diagnostic criteria)

Age 18 to 75 years (inclusive), male or female.

Disqualifiers

Severe cardiac dysfunction with left ventricular ejection fraction (LVEF) < 50%.

History of severe pulmonary impairment.

Concurrent diagnosis of another active malignancy.

Uncontrolled active infection.

Trial design

Design model

Single group

Treatments tested in this trial

  • In vivo BCMA/GPRC5D Tandem Dual CAR-T cell

    Drug

    Administration of in vivo BCMA/GPRC5D tandem dual CAR-T cells. Three dose levels (dose A, dose B, dose C) will be evaluated using a standard 3+3 dose-escalation design.

Treatment groups

18 Participants
are divided into 1 treatment group
Group A: In vivo BCMA/GPRC5D Tandem Dual CAR-TExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number and incidence rate with Each Grade of Cytokine Release Syndrome (CRS)

CRS severity will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Grading. The grade ranges from 1 to 4, where a higher grade indicates a worse outcome.

Time frame
1 month after treatment
2

Dose-limiting toxicities (DLTs)

Dose limiting toxicity will be assessed after injection

Time frame
1 month after treatment
3

Number and incidence rate of Each Grade of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)

ICANS severity is graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Grading, which incorporates the Immune Effector Cell-Associated Encephalopathy (ICE) assessment. The ICE score ranges from 0 to 10, with higher scores indicating better cognitive function. ICANS grade ranges from 1 to 4, where a higher grade indicates a worse outcome.

Time frame
1 month after treatment
4

Number and incidence rate of Treatment-Associated Adverse Events (AEs)

All other AEs would be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).

Time frame
1 years after treatment

Secondary outcomes

1

Overall Objective Response Rate (ORR)

Overall objective response rate (ORR) refers the sum of the proportions of complete remission (CR) and partial remission (PR).

Time frame
Day 14, Day 28, Month 2 , Month 3, Month 6, Month 9, Month 12, Month 18, Month24 after the treatment
2

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
3

progression free survival (PFS)

Progression free survival (PFS) refers to the time from treatment to the first disease progression or death of the patient for any reason.

Time frame
2 years after treatment
4

duration of response (DOR)

Duration of Response (DOR) refers to the time from the first assessment of plasma cell neoplasms as a complete or partial response to the first assessment of PD (Progressive Disease) or death from any cause.

Time frame
2 years after treatment

Other outcomes

Sponsors and contacts

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

Liping Dou

Lead sponsor

Chinese PLA General Hospital

Sponsor institution

Source ClinicalTrials.gov
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