In Vivo PICX CAR-T Therapy for R/R Multiple Myeloma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorChongqing Precision Biotech Co., Ltd
About this trial
This study is an investigator-initiated, single-center, single-arm clinical study with a target population of patients with relapsed or refractory multiple myeloma.
It is an early exploratory clinical study evaluating the safety, tolerability, and preliminary efficacy of PICX Injection, an in vivo prepared CAR-T cell therapy, in the treatment of relapsed or refractory multiple myeloma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years, male or female;
Disease progression after at least 2 prior standard treatment regimens; or poor response to primary therapeutic agents (e.g., immunomodulatory agents, proteasome inhibitors)
Disease progression within 18 months after first-line therapy
Presence of features associated with high risk of disease relapse or progression (e.g., high-risk cytogenetic abnormalities);
Disqualifiers
Prior treatment with CAR-T therapy or other gene-modified cell therapy before screening;
Presence of active central nervous system (CNS) involvement at screening (including brain parenchymal, meningeal, or spinal meningeal involvement, or positive cerebrospinal fluid for tumor cells), or other CNS diseases;
Chemotherapy, combination therapy with proteasome inhibitors and immunomodulatory agents, or other systemic anti-tumor drug therapy within 14 days or at least 5 half-lives before infusion (excluding intrathecal chemotherapy, which must be discontinued at least 1 week prior to infusion);
Radiotherapy to non-hematopoietic sites within 7 days, or to hematopoietic sites within 14 days before infusion;
Trial design
Design model
Single group
Treatments tested in this trial
Invivo CAR-T
Biological/VaccinePatients were enrolled and given a single dose of CAR-T injection intravenously, hospitalized for observation over the following month, and followed up for observation over the following 2 years.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Invivo CAR-TExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Maximal Tolerated Dose (MTD)
MTD will be determined based on Dose-Limiting Toxicity (DLTs) observed during the first 28 days of study treatment.
Time frame
Up to 28 days after infusion2
Incidence of Adverse Events (AE) after infusion
The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included.
Time frame
Up to 28 days after infusionSecondary outcomes
1
Objective Response Rate (ORR)
ORR is defined as the proportion of subjects achieving stringent complete remission (sCR), complete remission (CR), very good partial response (VGPR), and partial response (PR) per IMWG response criteria (2016).
Time frame
Day 28#Month 2#Month 3#Month 6#Month 12#Month 18#Month 242
Minimal Residual Disease (MRD) Negative Rate
MRD negativity rate is defined as the proportion of subjects achieving MRD-negative status as assessed by next-generation flow cytometry or sequencing.
Time frame
Month 3#Month 6#Month 12#Month 18#Month 243
Time to Response (TTR)
TTR is defined as the time from CAR-T infusion to first documented response (PR or better).
Time frame
Up to 24 months4
Duration of Response (DOR)
DOR is defined as the time from first documented response (PR or better) to first documented disease progression or death from any cause.
Time frame
up to 24 monthsSponsors and contacts
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Source ClinicalTrials.gov