B-Acute Lymphoblastic LeukemiaPhase 1NCT07239323
In VIVO CAR-T Therapy for Relapsed/Refractory Hematological Malignancies
A Phase 1 study testing Invivo CAR-T in people with B-Acute Lymphoblastic Leukemia and B Cell Non-Hodgkin's Lymphoma, 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 malignant hematological tumors. It is an early exploratory clinical study of the safety, tolerability and initial efficacy in the treatment of relapsed or refractory… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B-Acute Lymphoblastic Leukemia, B Cell Non-Hodgkin's Lymphoma, Multiple Myeloma
- 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
- 24 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 31 Dec 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 old, gender unrestricted;
- Confirmed diagnosis of relapsed/refractory malignant hematological tumors, including B-ALL, B-cell lymphoma and multiple myeloma;
- ECOG performance status score 0-2, with an expected survival period of ≥ 3 months;
- Blood routine test results during the screening period meet the following criteria:
- ① Hemoglobin ≥ 6 g/dL (no red blood cell transfusion within 1 week before screening), recombinant human erythropoietin (rhEPO) is allowed; for patients meeting the hemoglobin ≥ 6 g/dL criterion, red blood cell transfusion can be used to maintain hemoglobin ≥ 6 g/dL;
- Absolute neutrophil count (ANC) ≥ 600/μL (no use of granulocyte colony-stimulating factor [G-CSF] within 1 week before screening, or no use of pegylated G-CSF within 2 weeks before screening); ③ Platelet count ≥ 50,000/μL; ④ Lymphocyte count ≥ 500/μL;
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- Normal renal function during the screening period: creatinine clearance rate (CrCl) ≥ 45 mL/min (calculated using the Cockcroft-Gault formula);
- Liver function during the screening period meets the following criteria:
- ① Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 3.0 × ULN;
- ② Total bilirubin (TBIL) ≤ 2.0 × ULN (except for congenital hyperbilirubinemia such as Gilbert's syndrome, direct bilirubin can be relaxed to ≤ 1.5 × ULN);
- Cardiac function during the screening period meets the following criteria:
- ① Left ventricular ejection fraction (LVEF) ≥ 40% (measured by echocardiography or MUGA scan);
- ② No clinically significant pericardial effusion;
- ③ No clinically significant electrocardiogram (ECG) abnormalities;
- Pulmonary function during the screening period meets the following criteria: blood oxygen saturation (SpO₂) ≥ 90%;
- Women of childbearing age must have a negative pregnancy test during the screening period and before drug administration, and must not be in the lactation period;
- Men and women of childbearing age must agree to take effective contraceptive measures and not donate reproductive cells (including sperm or eggs) from the time of signing the informed consent form until 1 year after the end of study drug administration;
- The subject or their legally authorized representative has signed the informed consent form (ICF), indicating their understanding of the purpose and procedures of the study and their voluntary participation in this study.
Who cannot join
- Other anti-tumor treatments within the screening period (judged by the investigator comprehensively):
- ① Received chemotherapy, targeted therapy or immunotherapy within 5 half-lives before administration;
- ② Received radiotherapy within 4 weeks before administration (if the radiotherapy target area covers ≤ 5% of bone marrow reserve, the time limit for radiotherapy completion is not restricted);
- History of hematopoietic stem cell transplantation: Received allogeneic or autologous hematopoietic stem cell transplantation within 3 months before administration;
- History of other malignant tumors (except for this disease), except for the following situations:
- ① Received radical treatment and had no known active disease for ≥ 2 years before enrollment;
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- ② Had fully treated non-melanoma skin cancer in the past and had no active lesions at present;
- Received treatment related to vesicular stomatitis virus glycoprotein (VSVG) pseudotyped virus in the past;
- Had severe and uncontrolled infections (bacterial, viral, fungal, etc.) within the screening period;
- Clinically significant cardiac diseases:
- Had symptomatic heart failure or other serious cardiac diseases (such as severe arrhythmia);
- Had New York Heart Association (NYHA) Class III-IV congestive heart failure; ③ Had a myocardial infarction or received coronary artery bypass grafting (CABG) / coronary artery stent implantation within 6 months before signing the informed consent;
- Had clinically significant ventricular arrhythmia or a history of unexplained syncope; ⑤ Had a history of syncope (excluding cases caused by vasovagal reactions or dehydration); ⑥ Had a history of severe non-ischemic cardiomyopathy;
- Other clinically significant diseases, including but not limited to:
- Primary immunodeficiency; ② Had a stroke or seizure within 6 months before screening;
- Had clear clinical evidence of dementia or mental status changes; ④ Had Parkinson's disease, Parkinson-like movement disorders or a history of the above;
- Had undergone surgery within 2 weeks before administration, or planned to undergo surgery within 2 weeks after administration (local anesthesia surgery excluded);
- Had received live attenuated vaccines within 1 month before administration;
- Had a history of severe allergic reactions to this product or its formulation components;
- Patients who were not suitable for establishing intravenous access;
- The investigator believed that there were other conditions that made the patient unsuitable for participating in this 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
Wang Sanbin, PhD, +86 13187424131, sanbin1011@163.com
Sanbin
About this study
Official title: In Vivo-Generated Chimeric Antigen Receptor T-Cell Therapy for the Treatment of Relapsed or Refractory Hematologic Malignancies
This study is an investigator-initiated single center, single arm clinical study with a target population of patients with relapsed or refractory malignant hematological tumors.
It is an early exploratory clinical study of the safety, tolerability and initial efficacy in the treatment of relapsed or refractory malignant hematological tumors.
Read the detailed description
This is an open-label, single-arm study to evaluate the efficacy and safety of in vivo Chimeric Antigen Receptor T-Cell(CAR-T cell) therapy in patients with relapsed refractory malignant hematological tumors. Upon enrollment, subjects will receive an intravenous infusion of the in Vivo CAR-T preparation. Following the infusion, subjects will be hospitalized for observation, and subjects will be evaluated for safety and efficacy. Subjects will be followed for up to 2 years to determine if the disease is under control.
- Being tested
- Invivo CAR-T
- Keywords
- in Vivo, CAR-T, malignant hematological tumors
- Medical subject headings
- Burkitt Lymphoma, Lymphoma, B-Cell, 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 (1)
Objective Response Rate
Objective Response Rate(ORR) is defined as the proportion of subjects achieving complete remission(CR) and partial response(PR).
Measured: Day 28、Month 2、Month 3、Month 6、Month 12、Month 18、Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start1 Jul 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-Acute Lymphoblastic LeukemiaStudies 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing Precision Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wang Sanbin, MD, Principal investigator, 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07239323
- Sponsor's protocol ID
- PBC027-1
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 4 Nov 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 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo-Generated Chimeric Antigen Receptor T-Cell Therapy for the Treatment of Relapsed or Refractory Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT07239323
- Acronym / sponsor ID
- PBC027-1
- Keywords
- in Vivo, CAR-T, malignant hematological tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Chongqing Precision Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 20 Nov 2025 (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 malignant hematological tumors.
It is an early exploratory clinical study of the safety, tolerability and initial efficacy in the treatment of relapsed or refractory malignant hematological tumors.
Detailed description
This is an open-label, single-arm study to evaluate the efficacy and safety of in vivo Chimeric Antigen Receptor T-Cell(CAR-T cell) therapy in patients with relapsed refractory malignant hematological tumors. Upon enrollment, subjects will receive an intravenous infusion of the in Vivo CAR-T preparation. Following the infusion, subjects will be hospitalized for observation, and subjects will be evaluated for safety and efficacy. Subjects will be followed for up to 2 years to determine if the disease is under control.
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 (18 listed)
- Age ≥ 18 years old, gender unrestricted;
- Confirmed diagnosis of relapsed/refractory malignant hematological tumors, including B-ALL, B-cell lymphoma and multiple myeloma;
- ECOG performance status score 0-2, with an expected survival period of ≥ 3 months;
- Blood routine test results during the screening period meet the following criteria:
- ① Hemoglobin ≥ 6 g/dL (no red blood cell transfusion within 1 week before screening), recombinant human erythropoietin (rhEPO) is allowed; for patients meeting the hemoglobin ≥ 6 g/dL criterion, red blood cell transfusion can be used to maintain hemoglobin ≥ 6 g/dL;
Key exclusion criteria (21 listed)
- Other anti-tumor treatments within the screening period (judged by the investigator comprehensively):
- ① Received chemotherapy, targeted therapy or immunotherapy within 5 half-lives before administration;
- ② Received radiotherapy within 4 weeks before administration (if the radiotherapy target area covers ≤ 5% of bone marrow reserve, the time limit for radiotherapy completion is not restricted);
- History of hematopoietic stem cell transplantation: Received allogeneic or autologous hematopoietic stem cell transplantation within 3 months before administration;
- History of other malignant tumors (except for this disease), except for the following situations:
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.
1 secondary outcome
Objective Response Rate
Time frame: Day 28、Month 2、Month 3、Month 6、Month 12、Month 18、Month 24
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 4 Nov 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.
Wang Sanbin, MD principal investigator
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
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 B-Acute Lymphoblastic Leukemia and B Cell Non-Hodgkin's Lymphoma, 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 18 inclusion and 21 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 4 Nov 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 Wang Sanbin, 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 4 Nov 2026; AzTrials last refreshed its copy on 7 Nov 2026.