Relapsed or Refractory Multiple Myeloma (RRMM)Phase 1NCT07715630
In Vivo PICX CAR-T Therapy for R/R Multiple Myeloma
A Phase 1 study testing Invivo CAR-T in people with Relapsed or Refractory Multiple Myeloma (RRMM), run by Chongqing Precision Biotech Co., Ltd at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed or Refractory Multiple Myeloma (RRMM)
- What is being tested?
- Invivo CAR-T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 31 Jul 2026to 31 Jul 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years, male or female;
- Confirmed diagnosis of multiple myeloma meeting at least one of the following criteria:
- 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);
- At least one measurable disease indicator:
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- Serum M-protein ≥ 0.5 g/dL
- Urine M-protein ≥ 200 mg/24 hours
- Involved serum free light chain (sFLC) ≥ 10 mg/dL with an abnormal serum free light chain κ/λ ratio
- No evidence of extramedullary plasmacytoma (soft tissue plasmacytoma);
- ECOG performance status score 0-2;
- Expected survival period ≥ 3 months;
- Adequate bone marrow function within 1 month prior to screening:
- Hemoglobin ≥ 60 g/L;
- Absolute neutrophil count (ANC) ≥ 0.5 × 10⁹/L;
- Platelet count (PLT) ≥ 50 × 10⁹/L;
- Lymphocyte count ≥ 0.5 × 10⁹/L;
- CD3-positive T-cell absolute count ≥ 0.15 × 10⁹/L;
- Adequate vital organ function within 1 month prior to screening:
- Renal function: creatinine clearance rate (CrCl) ≥ 30 mL/min (calculated using the Cockcroft-Gault formula), or serum creatinine (Scr) ≤ 2.0 × upper limit of normal (ULN);
- Hepatic function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 × ULN; total bilirubin (TBIL) ≤ 2.0 × ULN (except for patients with congenital hyperbilirubinemia such as Gilbert's syndrome, in which case direct bilirubin may be ≤ 1.5 × ULN);
- Cardiac function: left ventricular ejection fraction (LVEF) ≥ 40%; no clinically significant pericardial effusion; and no clinically significant electrocardiogram (ECG) abnormalities (e.g., severe arrhythmia, myocardial ischemia, conduction block);
- Pulmonary function: blood oxygen saturation (SpO₂) ≥ 90% without supplemental oxygen;
- Women of childbearing potential must have a negative pregnancy test during the screening period and before study drug administration, and must not be lactating during the study;
- Men and women of childbearing potential must agree to use effective contraceptive measures (excluding unreliable methods such as rhythm method) from the time of signing the informed consent form until 1 year after the last dose of study drug, and must agree not to donate sperm or eggs;
- The subject or their legally authorized representative has signed the informed consent form (ICF), indicating understanding of the study purpose and procedures and voluntary participation.
Who cannot join
- 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;
- Received the following anti-tumor therapies prior to PICX Injection infusion:
- 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;
- BCMA-targeting antibody-based therapy within 3 months before infusion;
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- Active or uncontrolled infection requiring systemic treatment at screening (including bacterial, viral, fungal, or other infections);
- Presence of any of the following cardiac conditions:
- New York Heart Association (NYHA) Class III or IV congestive heart failure;
- Myocardial infarction, or coronary artery bypass grafting (CABG), or coronary stent placement within 6 months prior to screening;
- Clinically significant ventricular arrhythmia, or history of syncope of unknown cause (excluding vasovagal or dehydration-related);
- History of severe non-ischemic cardiomyopathy;
- Presence of other clinically significant diseases or conditions, including:
- Primary immunodeficiency disease;
- Cerebrovascular accident or seizure within 6 months prior to screening;
- Definite cognitive impairment or psychiatric/behavioral abnormalities (e.g., dementia, altered mental status), or severe psychiatric disorders;
- Parkinson's disease, Parkinsonism, or other movement disorders;
- Grade 2-4 acute graft-versus-host disease (GVHD) or moderate to severe chronic GVHD within 4 weeks prior to screening;
- History of other malignancies other than multiple myeloma prior to screening, except for:
- Malignancies treated with curative intent with no known active disease for ≥ 2 years prior to enrollment;
- Adequately treated cervical carcinoma in situ, basal cell or squamous cell skin carcinoma, localized prostate cancer after radical surgery, or ductal carcinoma in situ after radical surgery;
- Vaccination with live-attenuated vaccine within 4 weeks prior to screening;
- Known severe hypersensitivity to PICX Injection or any of its formulation components;
- Inability to establish venous access;
- Other conditions deemed by the investigator to be unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Kunming, Yunnan
Sanbin Wang, PhD, +86 13187424131, sanbin1011@163.com
About this study
Official title: In Vivo Prepared PICX Chimeric Antigen Receptor T-Cell Therapy for the Treatment of Relapsed/Refractory Multiple Myeloma
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.
Read the detailed description
This is a prospective, open-label, single-arm clinical investigation to assess the safety and efficacy of in vivo CAR-T cell therapy in patients with relapsed or refractory multiple myeloma.
Eligible subjects will be treated with PICX Injection as a single intravenous infusion. Post-infusion, subjects will remain hospitalized for close observation and undergo serial evaluations for adverse events and treatment response. Long-term follow-up will continue for up to 2 years to assess disease status and durability of response.
- Being tested
- Invivo CAR-T
- Keywords
- in Vivo, CAR-T, malignant hematological tumors
- Medical subject headings
- Recurrence, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invivo CAR-TBiological
Patients 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.
| Study group | Role | What they receive |
|---|---|---|
| Invivo CAR-T | Experimental | Not described Receives: Biological: Invivo CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Tolerated Dose (MTD)
MTD will be determined based on Dose-Limiting Toxicity (DLTs) observed during the first 28 days of study treatment.
Measured: Up to 28 days after infusion
Incidence of Adverse Events (AE) after infusion
The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included.
Measured: Up to 28 days after infusion
Secondary outcomes (6)
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).
Measured: Day 28#Month 2#Month 3#Month 6#Month 12#Month 18#Month 24
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.
Measured: Month 3#Month 6#Month 12#Month 18#Month 24
Time to Response (TTR)
TTR is defined as the time from CAR-T infusion to first documented response (PR or better).
Measured: Up to 24 months
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.
Measured: up to 24 months
Progression-Free Survival (PFS)
PFS is defined as the time from CAR-T infusion to first documented disease progression or death from any cause.
Measured: up to 24 months
Overall Survival (OS)
OS is defined as the time from CAR-T infusion to death from any cause.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start31 Jul 2026 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory Multiple Myeloma (RRMM)Studies of the same condition, open and under way.
- More trials run by Chongqing Precision Biotech Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing Precision Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07715630
- Sponsor's protocol ID
- PBC027-2
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Prepared PICX Chimeric Antigen Receptor T-Cell Therapy for the Treatment of Relapsed/Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT07715630
- Acronym / sponsor ID
- PBC027-2
- Keywords
- in Vivo, CAR-T, malignant hematological tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Chongqing Precision Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2026 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, open-label, single-arm clinical investigation to assess the safety and efficacy of in vivo CAR-T cell therapy in patients with relapsed or refractory multiple myeloma.
Eligible subjects will be treated with PICX Injection as a single intravenous infusion. Post-infusion, subjects will remain hospitalized for close observation and undergo serial evaluations for adverse events and treatment response. Long-term follow-up will continue for up to 2 years to assess disease status and durability of response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Invivo CAR-T | Experimental | Biological: Invivo CAR-T |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Age ≥ 18 years, male or female;
- Confirmed diagnosis of multiple myeloma meeting at least one of the following criteria:
- At least one measurable disease indicator:
- No evidence of extramedullary plasmacytoma (soft tissue plasmacytoma);
- ECOG performance status score 0-2;
Key exclusion criteria (25 listed)
- 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;
- Received the following anti-tumor therapies prior to PICX Injection infusion:
- Active or uncontrolled infection requiring systemic treatment at screening (including bacterial, viral, fungal, or other infections);
- Presence of any of the following cardiac conditions:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Invivo CAR-TPatients 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. | Biological | Invivo CAR-T |
Primary outcome
Maximal Tolerated Dose (MTD)
Time frame: Up to 28 days after infusion
MTD will be determined based on Dose-Limiting Toxicity (DLTs) observed during the first 28 days of study treatment.
Incidence of Adverse Events (AE) after infusion
Time frame: Up to 28 days after infusion
The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included.
6 secondary outcomes
Objective Response Rate (ORR)
Time frame: Day 28#Month 2#Month 3#Month 6#Month 12#Month 18#Month 24
Minimal Residual Disease (MRD) Negative Rate
Time frame: Month 3#Month 6#Month 12#Month 18#Month 24
Time to Response (TTR)
Time frame: Up to 24 months
Duration of Response (DOR)
Time frame: up to 24 months
Progression-Free Survival (PFS)
Time frame: up to 24 months
Overall Survival (OS)
Time frame: up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Invivo CAR-T in people with Relapsed or Refractory Multiple Myeloma (RRMM), run by Chongqing Precision Biotech Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sanbin Wang, PhD (+86 13187424131, sanbin1011@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal Tolerated Dose (MTD) (time frame: Up to 28 days after infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.