Acute Lymphoblastic Leukemia, in RelapsePhase 1NCT06641024
Clinical Research of CD19 Targeted CAR-T Cell in Relapsed/ Refractory B-ALL
A Phase 1 study testing MC-1-50 in people with Acute Lymphoblastic Leukemia, in Relapse and Refractory Acute Lymphoblastic Leukemia, run by Chongqing Precision Biotech Co., Ltd at 1 site in China.
Trial summary
This is a single-arm, open-label, dose-escalation phase I clinical study to explore the safety, tolerability, and cytokinetic characteristics of MC-1-50 cell formulation, and to preliminarily observe the efficacy of MC-1-50 cell formulation in subjects with relapsed/refractory CD19-positive B Cell Acute Lymphoblastic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Lymphoblastic Leukemia, in Relapse, Refractory Acute Lymphoblastic Leukemia
- What is being tested?
- MC-1-50
- 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 Nov 2024to 1 Nov 2039
- 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
- The patient or their guardian agrees to participate in this clinical trial and sign the ICF, indicating their understanding of the purpose and procedures of this clinical trial and willingness to participate in the study;
- Age ≥ 18 years old (including threshold), gender not limited;
- Diagnosed with B-cell acute lymphoblastic leukemia and meeting one of the following conditions:
- Refractory B-ALL: Early refractory patients who have not achieved complete remission of bone marrow after two courses of first-line systemic therapy upon initial diagnosis;
- Relapsed B-ALL:
- ① Early relapsed after complete remission (\< 12 months);
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- ② Late relapsed after complete remission (≥ 12 months) requires systemic therapy again, but if complete remission is not achieved or early treatment response is poor;
- ③ Having experienced 2 or more times bone marrow relapse;
- ④ Relapsed after allogeneic hematopoietic stem cell transplantation;
- Individuals with Philadelphia chromosome positive (Ph+) disease are eligible if they have relapsed/refractory disease despite treatment with at least 2 different tyrosine kinase inhibitors (TKIs); (Note: Except for those who are intolerant to TKI therapy, or have T315i mutations);
- Flow cytometry confirms the expression of CD19 in leukemia cells in the bone marrow. In individuals previously treated with targeted CD19 antibodies (such as blinatumomab), the proportion of CD19 positive cells in leukemia cells must be ≥ 90%;
- Morphological disease in the bone marrow (≥ 5% blasts);
- ECOG score 0-1;
- Expected survival time of more than 12 weeks;
- Adequate renal, hepatic, pulmonary and cardiac function defined as:
- Cardiac function: Echocardiography indicates left ventricular ejection fraction ≥ 50%;
- Renal function: serum creatinine ≤ 2.0 × ULN, or creatinine clearance rate ≥ 60ml/min (Cockcroft Gault formula);
- Hepatic function: ALT and AST ≤ 3.0 × ULN (may be relaxed to ≤ 5.0 × ULN in cases of combined liver infiltration);
- Total bilirubin ≤ 2.0 × ULN (Gilbert syndrome requires total bilirubin ≤ 3.0 × ULN);
- Pulmonary function: Blood oxygen saturation is ≥ 92% in non oxygen state.
- No serious mental disorders;
- Meet standards for apheresis or venous blood collection, and no other cell collection contraindications;
- Women of childbearing age who have a negative blood pregnancy test and all subjects agree to use reliable and effective contraceptive methods (excluding safe period contraception) for contraception within one year after receiving MC-1-50 cell infusion from the time of signing the informed consent form. Including but not limited to: abstinence, implantable progestogen contraceptives that can inhibit ovulation; Intrauterine device (IUD); Intrauterine hormone release system; Spouse vasectomy; Compound hormone contraceptives that can inhibit ovulation (oral, vaginal, and transdermal); Progesterone contraceptives (oral or injectable) that can inhibit ovulation; When male subjects have sex with fertile women, they must agree to use barrier contraception (such as condom plus spermicidal foam/gel/film/emulsion/suppository). At the same time, participants should commit not to donate eggs (oocytes, oocytes) or sperm for assisted reproduction within one year after cell infusion.
Who cannot join
- Isolated extramedullary disease;
- Central nervous system abnormalities: defined as CNS-2 and 3 according to NCCN guidelines (note: CNS-2 and 3 can be screened, but must be treated and recovered to CNS-1 before lymphodepleting chemotherapy and infusion);
- Transformation of chronic myeloid leukemia to acute biphenotypic leukemia;
- Individuals who have received CAR-T therapy or other gene modified cell therapies;
- Prior to apheresis, the following anti-tumor treatments have been received: chemotherapy, targeted therapy, and other drug treatments within 14 days or at least 5 half lives (whichever is shorter); Received radiation therapy within 14 days;
- HBsAg or HBcAb positive and HBV DNA is greater than the normal range; HCV antibody is positive and HCV RNA greater than the normal range; HIV antibody positive; syphilis positive; CMV DNA positive;HBsAg or HBcAb positive and HBV DNA is greater than the normal range; HCV antibody is positive and HCV RNA greater than the normal range; HIV antibody positive; syphilis positive;
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- Suffered from any of the following heart diseases:
- New York Heart Association (NYHA) stage III or IV congestive heart failure;
- Within the 6 months prior to enrollment, there has been a myocardial infarction, or a coronary artery bypass grafting (CABG) or stent implantation surgery has been performed;
- History of ventricular arrhythmias requiring treatment or unexplained syncope (excluding cases caused by vasovagal or dehydration);
- History of severe non-ischemic cardiomyopathy;
- Uncontrollable infection in the 2 weeks before enrollment;
- Acute grade 2-4 graft-versus-host disease (GVHD) or moderate to severe chronic GVHD within the first 4 weeks of enrollment;
- If a cerebrovascular accident or seizure occurs within the first 6 months of enrollment;
- Active autoimmune diseases;
- Deep vein or deep artery embolism event within the past 6 months prior to enrollment;
- Poor control of hypertension during screening is defined as systolic blood pressure ≥ 160mmHg and/or diastolic blood pressure ≥ 100mmHg (blood pressure values are measured based on the average of three readings taken at least 2 minutes apart. Patients with blood pressure ≥ 160/100mmHg at the initial screening can receive antihypertensive treatment, and if good control is achieved after treatment and blood pressure\<160/100mmHg, enrollment can be performed);
- History of malignancy other than fully treated cervical carcinoma in situ, basal cell or squamous cell carcinoma of the skin, local prostate cancer after radical surgery, and ductal carcinoma in situ of the breast after radical surgery;
- (attenuated) Live vaccine ≤ 4 weeks prior to enrollment;
- Have participated in other clinical trials within one month or five drug half lives (whichever is shorter) before enrollment;
- Women who are pregnant or breastfeeding, and male or female subjects who plan to have children within 1 year after receiving MC-1-50 cell infusion;
- Other situations considered by the investigator to be unsuitable to participate 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
Rui Jin hospital, Shanghai Jiao Tong university school of medicine
Shanghai
Jian qing Mi, M.D., +8613524488296, jianqingmi@shsmu.edu.cn
About this study
Official title: Phase I Clinical Study of CD19-targeting Chimeric Antigen Receptor T Lymphocyte (MC-1-50) for the Treatment of Relapsed/Refractory CD19-positive B-cell Acute Lymphoblastic Leukemia (B-ALL)
This is a single-arm, open-label, dose-escalation phase I clinical study to explore the safety, tolerability, and cytokinetic characteristics of MC-1-50 cell formulation, and to preliminarily observe the efficacy of MC-1-50 cell formulation in subjects with relapsed/refractory CD19-positive B Cell Acute Lymphoblastic Leukemia.
Read the detailed description
Based on the specific CD19-targeting CAR-T developed on the PrimeCARTM platform, the cell preparation time is about 3 days, which can greatly shorten the waiting time of patients, improve production efficiency and reduce production costs. At the same time, MC-1-50 products have a high proportion of T naive cells, which can play a therapeutic effect at a very low infusion dose to improve safety. In this study, a \"3+3\" design was adopted, and three dose groups were set up with 1×10^5/kg, 3×10^5/kg, and 5×10^5/kg CAR-positive cells, respectively (the upper limit of the total number of cells was not more than 5×10^7 CAR-positive cells). All subjects received only one infusion of MC-1-50 cells.
- Being tested
- MC-1-50
- Keywords
- B-ALL, CAR-T
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MC-1-50Biological
A single infusion of CD19 CAR-T cells will be administered intravenously after lymphodepletion chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| MC-1-50 | Experimental | Patients will be be treated with CD19 CAR- T cells Receives: Biological: MC-1-50 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Dose-limiting toxicity after CD19 CAR-T cell infusion
Measured: 1 month
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The incidence of adverse events after CAR-T cell infusion was assessed by the National Cancer Institute\'s Common Terminology Criteria for Adverse Events (CTCAE, version 5.0)
Measured: 1 month
Secondary outcomes (6)
AUCS of MC-1-50 cells [Cell dynamics]
AUCS is defined as the area under the curve in 90 days
Measured: 3 months
CMAX of MC-1-50 cell preparation [Cell dynamics]
CMAX is defined as the highest concentration of MC-1-50 cells expanded in peripheral blood
Measured: 3 months
TMAX of MC-1-50 cell preparation[Cell dynamics]
TMAX is defined as the time to reach the highest concentration
Measured: 3 months
Pharmacodynamics of MC-1-50 cell preparation[Cell dynamics]
The clearance degree of CD19-positive B cells in peripheral blood was detected by flow cytometry at the visit points specified in the research protocol
Measured: 3 months
Immunogenicity of pCAR-19B cells
The anti-CAR antibody was detected by ELISAt the visit points specified in the research protocol
Measured: 3 months
Objective response rate after MC-1-50 infusion [Efficacy]
Objective response rate after pCAR-19B infusion [Efficacy]
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Nov 2024 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic Leukemia, in RelapseStudies 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)
- Collaborators
- Ruijin Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06641024
- Sponsor's protocol ID
- PB12
- Status last verified
- Oct 2024
- First submitted
- 27 Sep 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- 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 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study of CD19-targeting Chimeric Antigen Receptor T Lymphocyte (MC-1-50) for the Treatment of Relapsed/Refractory CD19-positive B-cell Acute Lymphoblastic Leukemia (B-ALL)
- ClinicalTrials.gov ID
- NCT06641024
- Acronym / sponsor ID
- PB12
- Keywords
- B-ALL, CAR-T
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Chongqing Precision Biotech Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Ruijin Hospital
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2039 (estimated)
- First posted
- 15 Oct 2024 (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 is a single-arm, open-label, dose-escalation phase I clinical study to explore the safety, tolerability, and cytokinetic characteristics of MC-1-50 cell formulation, and to preliminarily observe the efficacy of MC-1-50 cell formulation in subjects with relapsed/refractory CD19-positive B Cell Acute Lymphoblastic Leukemia.
Detailed description
Based on the specific CD19-targeting CAR-T developed on the PrimeCARTM platform, the cell preparation time is about 3 days, which can greatly shorten the waiting time of patients, improve production efficiency and reduce production costs. At the same time, MC-1-50 products have a high proportion of T naive cells, which can play a therapeutic effect at a very low infusion dose to improve safety. In this study, a \"3+3\" design was adopted, and three dose groups were set up with 1×10^5/kg, 3×10^5/kg, and 5×10^5/kg CAR-positive cells, respectively (the upper limit of the total number of cells was not more than 5×10^7 CAR-positive cells). All subjects received only one infusion of MC-1-50 cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MC-1-50 | Experimental | Biological: MC-1-50Patients will be be treated with CD19 CAR- T cells |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- The patient or their guardian agrees to participate in this clinical trial and sign the ICF, indicating their understanding of the purpose and procedures of this clinical trial and willingness to participate in the study;
- Age ≥ 18 years old (including threshold), gender not limited;
- Diagnosed with B-cell acute lymphoblastic leukemia and meeting one of the following conditions:
- ① Early relapsed after complete remission (\< 12 months);
- ② Late relapsed after complete remission (≥ 12 months) requires systemic therapy again, but if complete remission is not achieved or early treatment response is poor;
Key exclusion criteria (22 listed)
- Isolated extramedullary disease;
- Central nervous system abnormalities: defined as CNS-2 and 3 according to NCCN guidelines (note: CNS-2 and 3 can be screened, but must be treated and recovered to CNS-1 before lymphodepleting chemotherapy and infusion);
- Transformation of chronic myeloid leukemia to acute biphenotypic leukemia;
- Individuals who have received CAR-T therapy or other gene modified cell therapies;
- Prior to apheresis, the following anti-tumor treatments have been received: chemotherapy, targeted therapy, and other drug treatments within 14 days or at least 5 half lives (whichever is shorter); Received radiation therapy within 14 days;
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 |
|---|---|---|
| MC-1-50A single infusion of CD19 CAR-T cells will be administered intravenously after lymphodepletion chemotherapy | Biological | MC-1-50 |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 1 month
Dose-limiting toxicity after CD19 CAR-T cell infusion
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 1 month
The incidence of adverse events after CAR-T cell infusion was assessed by the National Cancer Institute\'s Common Terminology Criteria for Adverse Events (CTCAE, version 5.0)
6 secondary outcomes
AUCS of MC-1-50 cells [Cell dynamics]
Time frame: 3 months
CMAX of MC-1-50 cell preparation [Cell dynamics]
Time frame: 3 months
TMAX of MC-1-50 cell preparation[Cell dynamics]
Time frame: 3 months
Pharmacodynamics of MC-1-50 cell preparation[Cell dynamics]
Time frame: 3 months
Immunogenicity of pCAR-19B cells
Time frame: 3 months
Objective response rate after MC-1-50 infusion [Efficacy]
Time frame: 3 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 15 Oct 2024.
- 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 MC-1-50 in people with Acute Lymphoblastic Leukemia, in Relapse and Refractory Acute Lymphoblastic Leukemia, 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 23 inclusion and 22 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: opening soon, as of the sponsor's last update on 15 Oct 2024. 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 Jian qing Mi, M.D. (+8613524488296, jianqingmi@shsmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: 1 month). 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 15 Oct 2024.