Acute Lymphoblastic Leukemia, Adult B-CellPhase 1/2NCT03984968
CD19 CAR-T Consolidation Therapy for Acute Lymphoblastic Leukemia
A Phase 1/2 study testing ssCART-19 cells combined with CD19+ feeding T cells (FTCs) infusion in people with Acute Lymphoblastic Leukemia, Adult B-Cell, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
This is a single-arm, open-label, single-center, phase I/II study to determine the safety and efficacy of CD19 CAR-T(ssCART-19) combined with autologous T cells engineered to express CD19, namely CD19+ feeding T cells (FTCs), as consolidation therapy in patients diagnosed with de novo Philadelphia chromosome-positive… Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Adult B-Cell
- What is being tested?
- ssCART-19 cells combined with CD19+ feeding T cells (FTCs) infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2017to 20 Jul 2040
- 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 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 15-65 years of age at the time of signing informed consent
- Diagnosed as de novo Philadelphia chromosome-positive CD19+ B-ALL
- Karnofsky performance status ≥ 60 or Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Unable to find a suitable donor or for other reasons to undergo allogeneic hematopoietic stem cell transplantation during the study
- Ability and willingness to adhere to the study visit schedule and all protocol requirements
- Voluntarily sign informed consent forms
Who cannot join
- Unable to tolerate any kind of TKIs (including the first- and second-generation tyrosine kinase inhibitors) for a long period.
- Subjects who have positive mutation(s) of the ABL kinase domain and require the third-generation tyrosine kinase inhibitors for long-term therapies.
- Inadequate hepatic function defined by aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3 × upper limit of normal (ULN) and direct bilirubin > 1.5 × ULN
- Inadequate renal function defined by serum creatinine > 1.6 mg/dL
- International ratio (INR) or partial thromboplastin time (PTT) > 1.5 x ULN
- Left ventricular ejection fraction < 50%
Show all 13Show fewer
- Ongoing treatment with chronic immunosuppressants
- Significant comorbid conditions or diseases which, in the judgment of the investigator, would place the subject at undue risk or interfere with the study; examples include, but are not limited to, cirrhotic liver disease, sepsis, recent significant traumatic injury, and other conditions
- Known human immunodeficiency virus (HIV) positivity
- Subjects with a history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control
- Subjects with second malignancies in addition to ALL
- Pregnant or lactating women, or subjects refusing to take effective contraception measures
- Other contraindications that are considered inappropriate to participate in this trial
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
About this study
Official title: Evaluation of the Safety and Efficacy of CD19 CAR-T Combined With Autologous T Cells Engineered to Express CD19 (CD19+ Feeding T Cells, FTCs) for Consolidation Treatment for Acute Lymphoblastic Leukemia
This is a single-arm, open-label, single-center, phase I/II study to determine the safety and efficacy of CD19 CAR-T(ssCART-19) combined with autologous T cells engineered to express CD19, namely CD19+ feeding T cells (FTCs), as consolidation therapy in patients diagnosed with de novo Philadelphia chromosome-positive CD19+ B-ALL.
The study will contain the following sequential phases: screening, lymphocyte apheresis, induction, and consolidation chemotherapies combined with tyrosine kinase inhibitors. Once in complete response, patients will receive two to four cycles of ssCART-19s, namely one cycle of ssCART-19 infusion (CAR-T1) followed by one to three cycles of ssCART-19 and CD19+ FTC infusion (CAR-T2-4). The role of CD19+ FTCs is to mimic leukemia cells. Therefore, they are expected to stimulate in vivo expansion and persistence of ssCART-19.
Read more
Considering the limited number of lymphocytes obtained by a single apheresis from patients and cost-efficacy, in addition to safety, we will explore the range of biologically active doses of FTCs in a phase I study. Based on preclinical data, FTCs' stimulation of ssCART-19 at a ratio of 1:1 could achieve the best activation response, so a 5×10^6/kg dosage of FTCs was set as the initial dosage in the study, and lower doses were also evaluated. In phase I, FTCs will be administered at the dose of 5×10^6/kg, 3.25×10^6/kg, or 2×10^6/kg two hours after ssCART-19 infusion on day 1 and once again administered at the same dose on day 8. After ssCART-19 and FTCs infusion, adverse events (AEs) as the primary endpoints will be recorded for 6 months; efficacy as the secondary endpoint will be assessed by detecting molecular response for 6 months, PFS, and OS for 2 years.
In phase II, we will expand the study at optimal biological doses of FTCs and further evaluate the efficacy and safety of the innovative combination therapy of ssCART-19 and FTCs. The primary endpoint was the complete molecular response (CMR). The secondary endpoints were RFS, OS, and adverse events (AEs) of the patients.
- Being tested
- ssCART-19 cells combined with CD19+ feeding T cells (FTCs) infusion
- Keywords
- feeding T cell, CD19 CAR-T therapy
- 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.
ssCART-19 cells combined with CD19+ feeding T cells (FTCs) infusionBiological
Phase 1: Optimal biological doses of feeding T cells (FTCs) identification. ssCART-19 cells combined with CD19+ FTCs were administered to Philadelphia chromosome-positive B-ALL patients with remission. ssCART-19 was infused at the dose of 5×10^6/kg on days 1 to 3 of the first cycle and on day 1 of the second to fourth cycle. CD19+ FTCs (5×10^6 cells/kg) were infused two hours after the infusion of ssCART-19 cells on day 1 and at the same dose alone on day 8 of the second to fourth cycle. Five patients were enrolled in this arm, and all the patients received four cycles of ssCART-19 consolidation.
ssCART-19 cells combined with CD19+ feeding T cells (FTCs) infusionBiological
Phase 1: Optimal biological doses of feeding T cells (FTCs) identification. ssCART-19 cells combined with CD19+ FTCs were administered to Philadelphia chromosome-positive B-ALL patients with remission. ssCART-19 was infused at the dose of 5×10^6/kg on days 1 to 3 of the first cycle and on day 1 of the second to fourth cycle. CD19+ FTCs (3.25×10^6 cells/kg) were infused two hours after the infusion of ssCART-19 cells on day 1 and at the same dose alone on day 8 of the second to fourth cycle. Four patients were enrolled in this arm, and all the patients received four cycles of ssCART-19 consolidation.
ssCART-19 cells combined with CD19+ feeding T cells (FTCs) infusionBiological
Phase 1: Optimal biological doses of feeding T cells (FTCs) identification. ssCART-19 cells combined with CD19+ FTCs were administered to Philadelphia chromosome-positive B-ALL patients with remission. ssCART-19 was infused at the dose of 5×10^6/kg on days 1 to 3 of the first cycle and on day 1 of the second to fourth cycle. CD19+ FTCs (2×10^6 cells/kg) were infused two hours after the infusion of ssCART-19 cells on day 1 and at the same dose alone on day 8 of the second to fourth cycle. Four patients were enrolled in this arm, and all the patients received four cycles of ssCART-19 consolidation.
ssCART-19 cells combined with CD19+ feeding T cells (FTCs) infusionBiological
Phase 2: Expansion Study. ssCART-19 cells combined with FTCs at the optimal biological dosage determined in the Phase 1 study were given to expanded Philadelphia chromosome-positive B-ALL patients with remission. The 5×10^6 cells/kg of CD19+ FTCs was the optimal biological dose determined in phase I. Therefore, CD19+ FTCs at 5×10^6 cells/kg were infused two hours after the infusion of ssCART-19 cells on day 1 and at the same dose alone on day 8 of the second to fourth cycle, while ssCART-19 was infused at the dose of 5×10^6/kg on days 1 to 3 of the first cycle and on day 1 of the second to fourth cycle. The Bayesian optimal design was applied to perform the futility assessment at the specified interim analyses. Thirty-eight evaluable subjects were recruited, and all the patients received at least two cycles of ssCART-19 consolidation.
| Study group | Role | What they receive |
|---|---|---|
| FTCs: High dose (Phase 1) | Experimental | Not described Receives: Biological: ssCART-19 cells combined with CD19+ feeding T cells (FTCs) infusion |
| FTCs: Medium dose (Phase 1) | Experimental | Not described Receives: Biological: ssCART-19 cells combined with CD19+ feeding T cells (FTCs) infusion |
| FTCs: Low dose (Phase 1) | Experimental | Not described Receives: Biological: ssCART-19 cells combined with CD19+ feeding T cells (FTCs) infusion |
| FTCs: High dose (Phase 2) | Experimental | Not described Receives: Biological: ssCART-19 cells combined with CD19+ feeding T cells (FTCs) infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1 Incidence of adverse events (AEs) and abnormal laboratory test results
AEs will be assessed according to the Common Terminology Criteria for Adverse Events 5.0 (CTCAE5.0).
Measured: 6 months after ssCART-19 consolidation termination (CAR-T4; each cycle is 3 months)
Phase 2 Molecular response after CD19 CAR-T consolidation therapy combined with CD19+ feeding T cells
Complete molecular response (CMR) was defined as the absence of a detectable BCR-ABL1 transcript with a sensitivity of 0.01%.
Measured: 3 months after each cycle of ssCART-19 consolidation termination (each cycle is 3 months)
Secondary outcomes (7)
Phase 1 Molecular response after CD19 CAR-T consolidation therapy combined with CD19+ feeding T cells.
Complete molecular response (CMR) was defined as the absence of a detectable BCR-ABL1 transcript with a sensitivity of 0.01%.
Measured: 3 months after each cycle of ssCART-19 consolidation termination (each cycle is 3 months)
Phase 1 The range of biologically active doses and optimal biological doses of CD19+ feeding T cells.
The range of biologically active doses and optimal biological doses of CD19+ feeding T cells will be determined.
Measured: 6 months after ssCART-19 consolidation termination (CAR-T4; each cycle is 3 months)
Phase 1 Overall survial (OS)
It is measured from the date of entry into this trial to the date of death from any cause; patients not known to have died at last follow-up are censored on the date they were last known to be alive.
Measured: 2 years
Phase 1 Relapse free survival（RFS）
It is measured from the date of achievement of a remission until the date of relapse from CR, or CRi, or death from any cause; patients not known to have any of these events are censored on the date they were last examined.
Measured: 2 years
Phase 2 Incidence of adverse events (AEs) and abnormal laboratory test results
AEs will be assessed according to the Common Terminology Criteria for Adverse Events 5.0 (CTCAE5.0).
Measured: 6 months after ssCART-19 consolidation termination (the specific date depending how many cycles the participants received; each cycle is 3 months)
Phase 2 Overall survial (OS)
It is measured from the date of entry into this trial to the date of death from any cause; patients not known to have died at last follow-up are censored on the date they were last known to be alive.
Measured: 2 years
Phase 2 Relapse free survival（RFS）
It is measured from the date of achievement of a remission until the date of relapse from CR, or CRi, or death from any cause; patients not known to have any of these events are censored on the date they were last examined.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2019
- Study start10 Jul 2017
- Primary completion20 Jul 2025
- Study completion20 Jul 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Lymphoblastic Leukemia, Adult B-CellStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheng-Li Xue, MD, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03984968
- Sponsor's protocol ID
- SZCART01
- Status last verified
- Dec 2025
- First submitted
- 11 Jun 2019
- Last updated
- 7 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Baseline characteristics of patients, outcomes
Publications
Chen LY, Gong WJ, Li MH, Zhou HX, Xu MZ, Qian CS, Kang LQ, Xu N, Yu Z, Qiao M, Zhang TT, Zhang L, Tian ZL, Sun AN, Yu L, Wu DP, Xue SL. Anti-CD19 CAR T-cell consolidation therapy combined with CD19+ feeding T cells and TKI for Ph+ acute lymphoblastic leukemia. Blood Adv. 2023 Sep 12;7(17):4913-4925. doi: 10.1182/bloodadvances.2022009072.
PubMed 36897251
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of CD19 CAR-T Combined With Autologous T Cells Engineered to Express CD19 (CD19+ Feeding T Cells, FTCs) for Consolidation Treatment for Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT03984968
- Acronym / sponsor ID
- SZCART01
- Keywords
- feeding T cell, CD19 CAR-T therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 10 Jul 2017 (actual)
- Primary completion
- 20 Jul 2025 (actual)
- Study completion
- 20 Jul 2040 (estimated)
- First posted
- 13 Jun 2019 (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, single-center, phase I/II study to determine the safety and efficacy of CD19 CAR-T(ssCART-19) combined with autologous T cells engineered to express CD19, namely CD19+ feeding T cells (FTCs), as consolidation therapy in patients diagnosed with de novo Philadelphia chromosome-positive CD19+ B-ALL.
The study will contain the following sequential phases: screening, lymphocyte apheresis, induction, and consolidation chemotherapies combined with tyrosine kinase inhibitors. Once in complete response, patients will receive two to four cycles of ssCART-19s, namely one cycle of ssCART-19 infusion (CAR-T1) followed by one to three cycles of ssCART-19 and CD19+ FTC infusion (CAR-T2-4). The role of CD19+ FTCs is to mimic leukemia cells. Therefore, they are expected to stimulate in vivo expansion and persistence of ssCART-19.
Considering the limited number of lymphocytes obtained by a single apheresis from patients and cost-efficacy, in addition to safety, we will explore the range of biologically active doses of FTCs in a phase I study. Based on preclinical data, FTCs' stimulation of ssCART-19 at a ratio of 1:1 could achieve the best activation response, so a 5×10^6/kg dosage of FTCs was set as the initial dosage in the study, and lower doses were also evaluated. In phase I, FTCs will be administered at the dose of 5×10^6/kg, 3.25×10^6/kg, or 2×10^6/kg two hours after ssCART-19 infusion on day 1 and once again administered at the same dose on day 8. After ssCART-19 and FTCs infusion, adverse events (AEs) as the primary endpoints will be recorded for 6 months; efficacy as the secondary endpoint will be assessed by detecting molecular response for 6 months, PFS, and OS for 2 years.
In phase II, we will expand the study at optimal biological doses of FTCs and further evaluate the efficacy and safety of the innovative combination therapy of ssCART-19 and FTCs. The primary endpoint was the complete molecular response (CMR). The secondary endpoints were RFS, OS, and adverse events (AEs) of the patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| FTCs: High dose (Phase 1) | Experimental | Biological: ssCART-19 cells combined with CD19+ feeding T cells (FTCs) infusion |
| FTCs: Medium dose (Phase 1) | Experimental | Biological: ssCART-19 cells combined with CD19+ feeding T cells (FTCs) infusion |
| FTCs: Low dose (Phase 1) | Experimental | Biological: ssCART-19 cells combined with CD19+ feeding T cells (FTCs) infusion |
| FTCs: High dose (Phase 2) | Experimental | Biological: ssCART-19 cells combined with CD19+ feeding T cells (FTCs) infusion |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 15-65 years of age at the time of signing informed consent
- Diagnosed as de novo Philadelphia chromosome-positive CD19+ B-ALL
- Karnofsky performance status ≥ 60 or Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Unable to find a suitable donor or for other reasons to undergo allogeneic hematopoietic stem cell transplantation during the study
- Ability and willingness to adhere to the study visit schedule and all protocol requirements
Key exclusion criteria (13 listed)
- Unable to tolerate any kind of TKIs (including the first- and second-generation tyrosine kinase inhibitors) for a long period.
- Subjects who have positive mutation(s) of the ABL kinase domain and require the third-generation tyrosine kinase inhibitors for long-term therapies.
- Inadequate hepatic function defined by aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3 × upper limit of normal (ULN) and direct bilirubin > 1.5 × ULN
- Inadequate renal function defined by serum creatinine > 1.6 mg/dL
- International ratio (INR) or partial thromboplastin time (PTT) > 1.5 x ULN
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 |
|---|---|---|
| ssCART-19 cells combined with CD19+ feeding T cells (FTCs) infusionPhase 1: Optimal biological doses of feeding T cells (FTCs) identification. ssCART-19 cells combined with CD19+ FTCs were administered to Philadelphia chromosome-positive B-ALL patients with remission. ssCART-19 was infused at the dose of 5×10^6/kg on days 1 to 3 of the first cycle and on day 1 of the second to fourth cycle. CD19+ FTCs (5×10^6 cells/kg) were infused two hours after the infusion of ssCART-19 cells on day 1 and at the same dose alone on day 8 of the second to fourth cycle. Five patients were enrolled in this arm, and all the patients received four cycles of ssCART-19 consolidation. | Biological | FTCs: High dose (Phase 1) |
| ssCART-19 cells combined with CD19+ feeding T cells (FTCs) infusionPhase 1: Optimal biological doses of feeding T cells (FTCs) identification. ssCART-19 cells combined with CD19+ FTCs were administered to Philadelphia chromosome-positive B-ALL patients with remission. ssCART-19 was infused at the dose of 5×10^6/kg on days 1 to 3 of the first cycle and on day 1 of the second to fourth cycle. CD19+ FTCs (3.25×10^6 cells/kg) were infused two hours after the infusion of ssCART-19 cells on day 1 and at the same dose alone on day 8 of the second to fourth cycle. Four patients were enrolled in this arm, and all the patients received four cycles of ssCART-19 consolidation. | Biological | FTCs: Medium dose (Phase 1) |
| ssCART-19 cells combined with CD19+ feeding T cells (FTCs) infusionPhase 1: Optimal biological doses of feeding T cells (FTCs) identification. ssCART-19 cells combined with CD19+ FTCs were administered to Philadelphia chromosome-positive B-ALL patients with remission. ssCART-19 was infused at the dose of 5×10^6/kg on days 1 to 3 of the first cycle and on day 1 of the second to fourth cycle. CD19+ FTCs (2×10^6 cells/kg) were infused two hours after the infusion of ssCART-19 cells on day 1 and at the same dose alone on day 8 of the second to fourth cycle. Four patients were enrolled in this arm, and all the patients received four cycles of ssCART-19 consolidation. | Biological | FTCs: Low dose (Phase 1) |
| ssCART-19 cells combined with CD19+ feeding T cells (FTCs) infusionPhase 2: Expansion Study. ssCART-19 cells combined with FTCs at the optimal biological dosage determined in the Phase 1 study were given to expanded Philadelphia chromosome-positive B-ALL patients with remission. The 5×10^6 cells/kg of CD19+ FTCs was the optimal biological dose determined in phase I. Therefore, CD19+ FTCs at 5×10^6 cells/kg were infused two hours after the infusion of ssCART-19 cells on day 1 and at the same dose alone on day 8 of the second to fourth cycle, while ssCART-19 was infused at the dose of 5×10^6/kg on days 1 to 3 of the first cycle and on day 1 of the second to fourth cycle. The Bayesian optimal design was applied to perform the futility assessment at the specified interim analyses. Thirty-eight evaluable subjects were recruited, and all the patients received at least two cycles of ssCART-19 consolidation. | Biological | FTCs: High dose (Phase 2) |
Primary outcome
Phase 1 Incidence of adverse events (AEs) and abnormal laboratory test results
Time frame: 6 months after ssCART-19 consolidation termination (CAR-T4; each cycle is 3 months)
AEs will be assessed according to the Common Terminology Criteria for Adverse Events 5.0 (CTCAE5.0).
Phase 2 Molecular response after CD19 CAR-T consolidation therapy combined with CD19+ feeding T cells
Time frame: 3 months after each cycle of ssCART-19 consolidation termination (each cycle is 3 months)
Complete molecular response (CMR) was defined as the absence of a detectable BCR-ABL1 transcript with a sensitivity of 0.01%.
7 secondary outcomes
Phase 1 Molecular response after CD19 CAR-T consolidation therapy combined with CD19+ feeding T cells.
Time frame: 3 months after each cycle of ssCART-19 consolidation termination (each cycle is 3 months)
Phase 1 The range of biologically active doses and optimal biological doses of CD19+ feeding T cells.
Time frame: 6 months after ssCART-19 consolidation termination (CAR-T4; each cycle is 3 months)
Phase 1 Overall survial (OS)
Time frame: 2 years
Phase 1 Relapse free survival（RFS）
Time frame: 2 years
Phase 2 Incidence of adverse events (AEs) and abnormal laboratory test results
Time frame: 6 months after ssCART-19 consolidation termination (the specific date depending how many cycles the participants received; each cycle is 3 months)
Phase 2 Overall survial (OS)
Time frame: 2 years
Phase 2 Relapse free survival（RFS）
Time frame: 2 years
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 7 May 2026.
- Derived from this study: PubMed 36897251Chen LY, Gong WJ, Li MH, Zhou HX, Xu MZ, Qian CS, Kang LQ, Xu N, Yu Z, Qiao M, Zhang TT, Zhang L, Tian ZL, Sun AN, Yu L, Wu DP, Xue SL. Anti-CD19 CAR T-cell consolidation therapy combined with CD19+ feeding T cells and TKI for Ph+ acute lymphoblastic leukemia. Blood Adv. 2023 Sep 12;7(17):4913-4925. doi: 10.1182/bloodadvances.2022009072.
- Individual participant dataSharing planned: Yes. Baseline characteristics of patients, outcomes
Related trials for Acute Lymphoblastic Leukemia, Adult B-Cell
Recruiting
A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymph...
B-All, Acute Lymphoblastic Leukemia
RecruitingPhase 1
A Phase I Dose Finding Study of MB-CART2219.1
Lymphoma, CLL
Not yet recruiting
Busulfan-Based Versus TBI-Based Conditioning for Adult ALL-CR2 Allo-HSCT
Acute Lymphoblastic Leukemia, Hematopoietic Stem Cell Transplantation
RecruitingPhase 3
A Study of Fludarabine Dosing in Children and Young Adults With B-cell Acute Lymphoblastic Leukemia
B-cell Acute Lymphoblastic Leukemia
Not yet recruitingPhase 2
Inotuzumab as Post-Trasplantation Therapy for Adult High-risk B-cell Precursor Acute Lymphoblastic Leukemia
Acute Lymphobkastic Leukemia, Adult
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. This study is not recruiting at the moment.
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 ssCART-19 cells combined with CD19+ feeding T cells (FTCs) infusion in people with Acute Lymphoblastic Leukemia, Adult B-Cell, run by The First Affiliated Hospital of Soochow University 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 6 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 7 May 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 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 1 Incidence of adverse events (AEs) and abnormal laboratory test results (time frame: 6 months after ssCART-19 consolidation termination (CAR-T4; each cycle is 3 months)). 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?
On the ClinicalTrials.gov record for NCT03984968, which also lists 1 linked publication.
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 7 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.