Acute Lymphobkastic LeukemiaPhase 1/2MSTH-CAR002NCT07162571
This is a Phase I/II Interventional, Open-label Treatment Study Designed to Evaluate the Safety and Efficacy of Anti CD 19/22 CAR- T Cells Immunotherapy for Adults With Relapsed or Refractory Acute Lymphoblastic Leukemia/Lymphoma.
A Phase 1/2 study testing CD19/22 CAR-T cells in people with Acute Lymphobkastic Leukemia and B Cell Lymphoma, run by Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology at 1 site in Belarus.
Trial summary
The purpose of this study is to estimate the safety and the efficacy of anti-CD19/22 CAR- T cells immunotherapy for adults with relapsed or refractory acute lymphoblastic leukemia/lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Lymphobkastic Leukemia, B Cell Lymphoma
- What is being tested?
- CD19/22 CAR-T cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteBelarus
- Study dates
- 10 Oct 2026to Dec 2032
- Phase
- Phase 1/2
- 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
- Male or female, aged ≥18 years.
- Willing and able to give written, informed consent.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1.
- Relapsed or refractory lymphoblastic leukemia/lymphoma.
- Chemotherapy-refractory disease after ≥1 lines of therapy
- Relapse after chemotherapy or after ASCT/Allo-HSCT.
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- Adequate organ system function including - Creatinine clearance ≥40 cc/min.
- Serum alanine aminotransferase / aspartate aminotransferase ≤2.5 x upper limit of normal (ULN).
- Total bilirubin ≤1.5 x ULN, except in subjects with Gilbert's syndrome.
- Left ventricular ejection fraction (LVEF) ≥50% (by echocardiogram [ECHO] or
- Baseline oxygen saturation >92% on room air and ≤Grade 1 dyspnoea.
- Have no active GVHD (Grade 2-4)
- Adequate bone marrow (BM) function - Absolute neutrophil count ≥1.0 × 10^9/L.
- Absolute lymphocyte count ≥0.3 × 10^9/L (at enrolment and prior to leukapheresis).
- Haemoglobin ≥80 g/L.
- Platelets ≥75 × 10^9/L
- 7. The expression of CD19 and/or CD22 on the tumor cells are reported as positive by either immunohistochemistry or flow cytometry
Who cannot join
- Females who are pregnant or lactating.
- History or presence of clinically relevant CNS pathology such as epilepsy, paresis, aphasia, stroke within prior 3 months, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, uncontrolled mental illness, or psychosis.
- Patients with active CNS involvement by malignancy. Patients with history of central nervous system (CNS) involvement with malignancy may be eligible if CNS disease has been effectively treated and provided treatment was at least 4 weeks prior to enrolment (at least 8 weeks prior to CAR-T infusion).
- Clinically significant, uncontrolled heart disease or a recent (within 12 months) cardiac event.
- Active bacterial, viral or fungal infection requiring systemic treatment. Active or latent hepatitis B infection or hepatitis C infection. Testing positive for human immunodeficiency virus, human T cell lymphotropic virus (HTLV1 and 2) or syphilis.
- History of autoimmune disease resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 24 months.
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- 6. Evidence of active pneumonitis on chest computed tomography (CT) scan at screening or history of drug-induced pneumonitis, idiopathic pulmonary fibrosis, organising pneumonia, or idiopathic pneumonitis.
- 7. History of other malignant neoplasms unless disease free for at least 24 months (carcinoma in situ, non-melanoma skin cancer, breast or prostate cancer on hormonal therapy allowed).
- 8. The following medications are excluded:
- Steroids: Therapeutic doses of corticosteroids within 7 days of leukapheresis or 72 hours prior to CAR-T administration. However, physiological replacement, topical, and inhaled steroids are permitted.
- Immunosuppression: Immunosuppressive medication must be stopped ≥2 weeks prior to leukapheresis or CAR-T cells infusion.
- Cytotoxic chemotherapies within 1 week of CAR-T cellsinfusion and 1 week prior to leukapheresis.
- Antibody therapy use including anti-CD20/19/22 therapy within 2 weeks prior to CAR-T cells infusion.
- Granulocyte-colony stimulating factor less than 14 days prior to leukapheresis.
- Live vaccine ≤4 weeks prior to enrolment.
- Prophylactic intrathecal therapy: Methotrexate within 4 weeks and other intrathecal chemotherapy (e.g. Ara-C) within 2 weeks prior to starting pre-conditioning chemotherapy.
- Prior limited radiation therapy within 2 weeks of CAR-T cells infusion. 9. Known allergy to albumin, dimethyl sulphoxide (DMSO), cyclophosphamide or fludarabine or tocilizumab.
- 10. Any other condition that in the Investigator's opinion would make the patient unsuitable for the clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belarus1 site
State Institution Minsk Scientific and Practical Center for Surgery, Transplantology, and Hematology
Minsk, 220087
About this study
Official title: Phase I/II Open-label Study Evaluating The Safety And Efficacy of Anti CD19/22 CAR-T Cells Therapy Adults With R/ R Leukemia/ Lymphoma
The purpose of this study is to estimate the safety and the efficacy of anti-CD19/22 CAR- T cells immunotherapy for adults with relapsed or refractory acute lymphoblastic leukemia/lymphoma.
Read the detailed description
Locally manufactured second generation autologous CD19/22 CAR-T cells are used for immunotherapy. Protocol treatment includes leukapheresis in order to harvest T cells, lymphodepleting conditioning (fludarabine + cyclophosphamide) followed by one dual targeting CAR-T cells infusion.
The Main research objectives of the Phase I:
To preliminarily explore the safety (incidence of CRS, ICANS, HLH, infections, late ICAHT, parkinsonism and cytopenias) and tolerability.
The Secondary research objectives of the Phase I:
To explore the pharmacokinetics of CAR-T cells.
The Main research objectives of the Phase II:
Overall response rate, including complete response (CR) and partial response (PR) rates.
The Secondary research objectives of the Phase II:
Duration of response (DOR). Progression-free survival rates. Overall survival rates.
- Conditions
- Acute Lymphobkastic Leukemia, B Cell Lymphoma
- Being tested
- CD19/22 CAR-T cells
- Keywords
- CD19/22 CAR-T cells, Acute Lymphobkastic Leukemia, B Cell lymphoma, dual targeting CAR-T therapy
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD19/22 CAR-T cellsBiological
Following preconditioning with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with doses from 50 x 10⁶ to 150 x 10⁶ CD19/CD22 CAR-T cells
| Study group | Role | What they receive |
|---|---|---|
| CD19/22 CAR-T cells immunotherapy | Experimental | Not described Receives: Biological: CD19/22 CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I. Safety
Number of Participants With Grade 3-5 Toxicities. Adverse events will be graded according to the CTCAE v5.0
Measured: 1 month post CAR-T cells infusion
Phase II. Overall response rate
Including complete response (CR) and partial response (PR) rates
Measured: 3 months post CAR-T cells infusion
Secondary outcomes (4)
Phase I. CAR-T proliferation
To explore the pharmacokinetics of CAR-T cells: duration of expansion of CAR-T cells by flow cytometry, peak of expansion of CAR-T cells
Measured: 3 months post CAR-T cells infusion
Phase II. Efficacy: Overall survival rates
Overall survival rates
Measured: 12 months post CAR-T cells infusion
Phase II. Progression-free survival rates
progression-free survival time
Measured: 12 months post CAR-T cells infusion
Phase II. Duration of response
duration of response
Measured: 12 months post CAR-T cells infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start10 Oct 2026
- Primary completionDec 2030 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphobkastic LeukemiaStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mikhail Uss, Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07162571
- Sponsor's protocol ID
- 23.25
- Acronym
- MSTH-CAR002
- Status last verified
- Oct 2026
- First submitted
- 29 Aug 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Open-label Study Evaluating The Safety And Efficacy of Anti CD19/22 CAR-T Cells Therapy Adults With R/ R Leukemia/ Lymphoma
- ClinicalTrials.gov ID
- NCT07162571
- Acronym / sponsor ID
- MSTH-CAR002 / 23.25
- Conditions
- Acute Lymphobkastic Leukemia, B Cell Lymphoma
- Keywords
- CD19/22 CAR-T cells, Acute Lymphobkastic Leukemia, B Cell lymphoma, dual targeting CAR-T therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- Minsk Scientific-Practical Center for Surgery, Transplantation and HematologyOther government
- Study start
- 10 Oct 2026 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 9 Sep 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.
The purpose of this study is to estimate the safety and the efficacy of anti-CD19/22 CAR- T cells immunotherapy for adults with relapsed or refractory acute lymphoblastic leukemia/lymphoma.
Detailed description
Locally manufactured second generation autologous CD19/22 CAR-T cells are used for immunotherapy. Protocol treatment includes leukapheresis in order to harvest T cells, lymphodepleting conditioning (fludarabine + cyclophosphamide) followed by one dual targeting CAR-T cells infusion.
The Main research objectives of the Phase I:
To preliminarily explore the safety (incidence of CRS, ICANS, HLH, infections, late ICAHT, parkinsonism and cytopenias) and tolerability.
The Secondary research objectives of the Phase I:
To explore the pharmacokinetics of CAR-T cells.
The Main research objectives of the Phase II:
Overall response rate, including complete response (CR) and partial response (PR) rates.
The Secondary research objectives of the Phase II:
Duration of response (DOR). Progression-free survival rates. Overall survival rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CD19/22 CAR-T cells immunotherapy | Experimental | Biological: CD19/22 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 (17 listed)
- Male or female, aged ≥18 years.
- Willing and able to give written, informed consent.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1.
- Relapsed or refractory lymphoblastic leukemia/lymphoma.
- Adequate organ system function including - Creatinine clearance ≥40 cc/min.
Key exclusion criteria (18 listed)
- Females who are pregnant or lactating.
- History or presence of clinically relevant CNS pathology such as epilepsy, paresis, aphasia, stroke within prior 3 months, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, uncontrolled mental illness, or psychosis.
- Patients with active CNS involvement by malignancy. Patients with history of central nervous system (CNS) involvement with malignancy may be eligible if CNS disease has been effectively treated and provided treatment was at least 4 weeks prior to enrolment (at least 8 weeks prior to CAR-T infusion).
- Clinically significant, uncontrolled heart disease or a recent (within 12 months) cardiac event.
- Active bacterial, viral or fungal infection requiring systemic treatment. Active or latent hepatitis B infection or hepatitis C infection. Testing positive for human immunodeficiency virus, human T cell lymphotropic virus (HTLV1 and 2) or syphilis.
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 |
|---|---|---|
| CD19/22 CAR-T cellsFollowing preconditioning with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with doses from 50 x 10⁶ to 150 x 10⁶ CD19/CD22 CAR-T cells | Biological | CD19/22 CAR-T cells immunotherapy |
Primary outcome
Phase I. Safety
Time frame: 1 month post CAR-T cells infusion
Number of Participants With Grade 3-5 Toxicities. Adverse events will be graded according to the CTCAE v5.0
Phase II. Overall response rate
Time frame: 3 months post CAR-T cells infusion
Including complete response (CR) and partial response (PR) rates
4 secondary outcomes
Phase I. CAR-T proliferation
Time frame: 3 months post CAR-T cells infusion
Phase II. Efficacy: Overall survival rates
Time frame: 12 months post CAR-T cells infusion
Phase II. Progression-free survival rates
Time frame: 12 months post CAR-T cells infusion
Phase II. Duration of response
Time frame: 12 months post CAR-T cells infusion
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 16 Oct 2026.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CD19/22 CAR-T cells in people with Acute Lymphobkastic Leukemia and B Cell Lymphoma, run by Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology at 1 site in Belarus.
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 17 inclusion and 18 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: enrolling by invitation, as of the sponsor's last update on 16 Oct 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 Belarus. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I. Safety (time frame: 1 month post CAR-T cells 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 16 Oct 2026.