Relapsed Refractory Acute Lymphoblastic LeukemiaPhase 1CD19 CART CELLNCT07361029
CD19 Chimeric Antigen Receptor (CAR) T Cells in Adults With Relapsed/Refractory CD19 Positive Acute Lymphoblastic Leukemia
A Phase 1 study testing CAR T cells chimeric antigen receptor cells in people with Relapsed Refractory Acute Lymphoblastic Leukemia, run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.
Trial summary
This is a Phase Ia, open label, dose finding single center trial designed to evaluate the maximum tolerated dose, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of CD19 CAR T cells targeting the B cell surface antigen CD19 following administration of chemotherapy lymphodepletion regimen in… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Relapsed Refractory Acute Lymphoblastic Leukemia
- What is being tested?
- CAR T cells chimeric antigen receptor cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 29 Jul 2025to 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 18 to 75 years old (patients is older than 18.0 and less than 75.0 years old) 2. Signed informed consent form 3. Ability to comply with the study protocol 4. Relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL):
- Second or greater bone marrow (BM) relapse; or
- Primary refractory, defined as not achieving complete remission (CR) after 2 cycles of a standard chemotherapy regimen, or Chemo-refractory, defined as not achieving CR after 1 cycle of standard chemotherapy for relapsed leukemia; or
- Philadelphia chromosome-positive ALL intolerant of or with 2 failed lines of tyrosine kinase inhibitor (TKI) therapy; or
- Relapsed patients ineligible for Allogeneic Stem Cell Transplant (AlloSCT) due to lack of a suitable donor.
- Relapsed after AlloSCT. at least 12 weeks after alloSCT or relapse happened after withdrawing the post-transplant immunosuppression
Show all 19Show fewer
- Relapsed after prior CAR T cell and still CD19 positive. . (Patients with a history of ≥grade CRS, ≥ grade 3 ICANS, or severe hypersensitivity reactions following prior CAR T-cell therapy should be excluded.) 5. BM with ≥5% lymphoblasts by morphologic assessment at screening 6. For relapsed patients, documentation of CD19 tumor expression in BM or peripheral blood by flow cytometry or immunohistochemistry within 1 month of study entry 7. Patients with a history of CNS or meningeal involvement must be in a documented clinical remission prior to registration.
- 8. Alanine aminotransferase (ALT) ≤5 times the upper limit of normal for age 9. Bilirubin ≤2 x ULN 10. Patients with good renal function defined as Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 cc/min.
- 11. Absolute Neutrophil Count (ANC): Patients must have an ANC ≥ 1.0 x 109
- /L without the use of growth factors 12. Platelet Count: Patients must have a platelet count ≥ 50 x 109/L without transfusion support within 7 days of screening.
- 13. Absolute Lymphocyte Count: Patients must have an absolute lymphocyte count ≥ 0.5 x 109/L.
- 14. Definition of Adequate Organ Function:
- Renal Function: Glomerular Filtration Rate (GFR) > 60mL/min.
- Hepatic Function: AST/ALT ≤ 5 x ULN and bilirubin ≤ 2 x ULN. Total bilirubin 1.5 ULN (except Gilbert's syndrome).
- Pulmonary Function: Adequate respiratory function defined as oxygen saturation ≥ 93% on room air.
- Cardiac Function: Left ventricular ejection fraction (LVEF) ≥ 45% by echocardiogram or MUGA scan and QTcF ≤ 480 ms. 15. Minimum level of pulmonary reserve defined as grade ≤1 dyspnea and pulse oxygenation >93% on room air 16. Left ventricular ejection fraction ≥45% confirmed by echocardiogram within 30 days of screening 17. Karnofsky ≥ 70% and /or ECOG 0-2 at the time of screening 18. Women of child bearing age should have negative serum pregnancy test within 7 days prior to enrollment 19. If sexually active:
- <!-- -->
- Females should use effective birth control 1 month prior to screening until 12 months after CAR T cell infusion
- Males to use condom for six months after infusion 20. Meet institutional criteria to undergo leukapheresis or have an acceptable, stored leukapheresis product
Who cannot join
- Clinically Active central nervous system (CNS) involvement by malignancy
- History or presence of uncontrolled underlying seizure disorder not related to B-ALL
- History of or active clinically significant cardiovascular dysfunction, including any of the following:
- History of stroke within 24 months prior to the CD19 CAR T cells infusion or with ongoing sequelae
- History of transient ischemic attack within 12 months prior to the CD19 CAR T cells infusion
- History of myocardial infarction within 36 months prior to the CD19 CAR T cells infusion
Show all 40Show fewer
- Symptomatic congestive heart failure (NYHA class III/IV), unstable angina pectoris, cardiac arrhythmia requiring therapy
- Uncontrolled arrhythmias, or history of or active ventricular arrhythmia requiring medication
- Active or history of coronary heart disease that remains symptomatic
- Active or history of unstable or stable angina
- Left ventricular ejection fraction (LVEF) < 45% confirmed by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA) scan
- Creatinine clearance < 60
- Concomitant genetic syndromes associated with Bone Marrow (BM) failure states, such as Fanconi anemia, Kostmann syndrome, Schwachman syndrome, or any other BM failure syndrome; patients with Down syndrome are not excluded
- Burkitt lymphoma/leukemia
- Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and no evidence of active disease
- Treatment with any prior gene therapy product (except prior CAR-T cell therapy)
- Positive HIV test within 8 weeks of screening
- Serologic status reflecting active hepatitis B or C infection: Patients that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment. (PCR positive patients will be excluded.)
- Received an investigational medicinal product on trial within the 30 days prior to screening
- Pregnant
- Lactating
- Women of child-bearing potential and all male participants, unless using highly effective methods of contraception for 1 year after CAR-T infusion
- Therapeutic systemic doses of steroids (>=0.5mg/kg prednisone equivalent) must be stopped >72 hours prior to lymphodepletion
- TKIs and hydroxyurea must be stopped >72 hours prior to lymphodepletion
- The following drugs must be stopped >1 week prior to lymphodepleting chemotherapy:
- vincristine, 6- mercaptopurine, 6-thioguanine, methotrexate 2 weeks prior to CART infusion: salvage chemotherapy (e.g., clofarabine, cytosine arabinoside >100 mg/m2
- , anthracyclines, cyclophosphamide, methotrexate ≥25 mg/m2
- ), excluding the required lymphodepleting chemotherapy drugs
- Pegylated asparaginase must be stopped >4 weeks prior to CAR T cell infusion
- CNS disease prophylaxis and/or intrathecal chemotherapy must be stopped >1 week prior to CAR T cell infusion
- Radiation therapy at non-CNS site must be completed >2 weeks prior to CAR T Cell infusion
- CNS-directed radiation must be completed >8 weeks prior to CAR T cell infusion
- Known History of severe allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in study (including, but not limited to, cyclophosphamide and fludarabine used in the lymphodepleting chemotherapy, DMSO used as a cryoprotectant in the cell media, etc.)
- Autologous transplant within 6 weeks of planned CAR-T cell infusion
- Evidence of myelodysplasia or cytogenetic abnormality indicative of myelodysplasia on any bone marrow biopsy prior to initiation of therapy.
- Primary Immunodeficiency Patients:
- Patients with known primary immunodeficiency disorders are excluded due to increased risk of adverse outcomes.
- Recent Live Vaccine Administration:
- Patients who have received a live vaccine within 4 weeks prior to enrolment are excluded.
- Additionally, vaccination with live vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia1 site, 1 recruiting
- Recruiting
King Faisal Specialist Hospital and Research Center
Riyadh, Riyadh Region
Riad El Fakih, 00966539056287, relfakih1@kfshrc.edu.sa
About this study
Official title: Phase Ia Study of a LentiGen® CD19 Chimeric Antigen Receptor (CAR) T Cells in Adult Patients With Relapsed/Refractory CD19 Positive Acute Lymphoblastic Leukemia (ALL) Using a Closed Transduction System
This is a Phase Ia, open label, dose finding single center trial designed to evaluate the maximum tolerated dose, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of CD19 CAR T cells targeting the B cell surface antigen CD19 following administration of chemotherapy lymphodepletion regimen in adults (age 18 - 75) with relapsed/refractory acute lymphoblastic leukemia (ALL).
Read the detailed description
Approximately 24 patients are planned to be enrolled in four cohorts during the dose-escalation stage. Within each cohort, 3 patients will receive treatment with CD19 CAR T cells.
The starting dose level is 5x10*5cells/kg, administered as a single dose by IV infusion. Dose escalation will proceed in accordance with the dose-escalation Dose-escalation decisions will be made by the Data Safety Monitoring Board (DSMB) in consultation with the investigators . CD19 CAR T cells administration between the first and second patient in each dose level will be separated by a minimum of 4 weeks. CD19 CAR T cells administration between each subsequent patient in a dose level will be separated by a minimum of 2 weeks.
- Being tested
- CAR T cells chimeric antigen receptor cells
- Keywords
- CD19 CAR T, relapsed/refractory acute lymphoblastic leukemia (ALL).
- 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.
CAR T cells chimeric antigen receptor cellsOther
CAR T Cells
| Study group | Role | What they receive |
|---|---|---|
| single arm dose finding | Experimental | Not described Receives: Other: CAR T cells chimeric antigen receptor cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
To assess the maximum tolerated dose, safety and tolerability of intravenous infusion of CD19 CAR T cells using based on incidence, nature, and severity of AEs graded according to National Cancer Institute Common Terminology Criteria for Adverse Events, version 5 (NCI CTCAE v5), cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS).
Measured: throughout study completion, Day1 to 5 years
Secondary outcomes (11)
Evaluate the success rate of product manufacturing
To evaluate the success rate of product manufacturing based on product meeting release criteria
Measured: Pre-infusion
preliminary anti-tumor activity of CD19 CAR T cells in treated patients
Preliminary anti-tumor activity of CD19 CAR T post-infusion and Minimal residual disease (MRD) status at 1st-month and 2nd- month post-infusion in treated patient
Measured: Day30 and Day 60
Safety of CD19 CAR T cells
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.
Measured: Day 1- 8, Day 14-21, Day30, Day60, Day90, Day120, Day180, Day270, and yearly
Safety of CD19 CAR T cells
Number of Participants with Treatment Related immune effector cell-associated neurotoxicity syndrome (ICANS). will be graded according to ASTCT criteria.
Measured: Day 1- 8, Day 14-21, Day30, Day60, Day90, Day120, Day180, Day270, and yearly]
safety of CD19 CAR T cells
Number of Participants with Treatment-Related cytokine release syndrome (CRS)
Measured: Day 1- 8, Day 14-21, Day30, Day60, Day90, Day120, Day180, Day270, and yearly
To characterize the pharmacokinetic (PK) profile of CD19 CAR T cells
To characterize the pharmacokinetic (PK) profile of CD19 CAR T cells using area under the curve (AUC)
Measured: Day7, Day14, Day28, 2month, 4 month, 6month,10month,12month 14month,16month,18month,20month, 22month, and 24month
To characterize the pharmacokinetic (PK) profile of CD19 CAR T cells
To characterize the pharmacokinetic (PK) profile of CD19 CAR T cells using maximum concentration (Cmax)
Measured: Day7, Day14, Day28, 2month, 4 month, 6month,10month,12month 14month,16month,18month,20month, 22month, and 24month
To characterize the pharmacokinetic (PK) profile of CD19 CAR T cells
To characterize the pharmacokinetic (PK) profile of CD19 CAR T cells using minimum concentration (Cmin)
Measured: Day7, Day14, Day28, 2month, 4 month, 6month,10month,12month 14month,16month,18month,20month, 22month, and 24month
To characterize the pharmacokinetic (PK) profile of CD19 CAR T cells
To characterize the pharmacokinetic (PK) profile of CD19 CAR T cells using clearance (Cl)
Measured: Day7, Day14, Day28, 2month, 4 month, 6month,10month,12month 14month,16month,18month,20month, 22month, and 24month
To characterize the pharmacokinetic (PK) profile of CD19 CAR T cells
To characterize the pharmacokinetic (PK) profile of CD19 CAR T cells using volume (V)
Measured: Day7, Day14, Day28, 2month, 4 month, 6month,10month,12month 14month,16month,18month,20month, 22month, and 24month
To characterize the pharmacokinetic (PK) profile of CD19 CAR T cells
To characterize the pharmacokinetic (PK) profile of CD19 CAR T cells using half-life (T1/2)
Measured: Day7, Day14, Day28, 2month, 4 month, 6month,10month,12month 14month,16month,18month,20month, 22month, and 24month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start29 Jul 2025
- Primary completionJul 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed Refractory Acute Lymphoblastic 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Chimeric Antigen Receptor (CAR)-modified T cell (CD19)
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Faisal Specialist Hospital & Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Miltenyi Biomedicine GmbH
- Responsible party
- Principal investigator, Riad El Fakih, King Faisal Specialist Hospital & Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07361029
- Sponsor's protocol ID
- 2191207
- Acronym
- CD19 CART CELL
- Status last verified
- Jan 2026
- First submitted
- 27 Aug 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: yes with Miltenyi our collaborator
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ia Study of a LentiGen® CD19 Chimeric Antigen Receptor (CAR) T Cells in Adult Patients With Relapsed/Refractory CD19 Positive Acute Lymphoblastic Leukemia (ALL) Using a Closed Transduction System
- ClinicalTrials.gov ID
- NCT07361029
- Acronym / sponsor ID
- CD19 CART CELL / 2191207
- Keywords
- CD19 CAR T, relapsed/refractory acute lymphoblastic leukemia (ALL).
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- King Faisal Specialist Hospital & Research CenterUniversity, hospital or other
- Collaborators
- Miltenyi Biomedicine GmbH
- Study start
- 29 Jul 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 22 Jan 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 is a Phase Ia, open label, dose finding single center trial designed to evaluate the maximum tolerated dose, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of CD19 CAR T cells targeting the B cell surface antigen CD19 following administration of chemotherapy lymphodepletion regimen in adults (age 18 - 75) with relapsed/refractory acute lymphoblastic leukemia (ALL).
Detailed description
Approximately 24 patients are planned to be enrolled in four cohorts during the dose-escalation stage. Within each cohort, 3 patients will receive treatment with CD19 CAR T cells.
The starting dose level is 5x10*5cells/kg, administered as a single dose by IV infusion. Dose escalation will proceed in accordance with the dose-escalation Dose-escalation decisions will be made by the Data Safety Monitoring Board (DSMB) in consultation with the investigators . CD19 CAR T cells administration between the first and second patient in each dose level will be separated by a minimum of 4 weeks. CD19 CAR T cells administration between each subsequent patient in a dose level will be separated by a minimum of 2 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Chimeric Antigen Receptor (CAR)-modified T cell (CD19)
| Arm | Type | Receives |
|---|---|---|
| single arm dose finding | Experimental | Other: CAR T cells chimeric antigen receptor cells |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Patients aged between 18 to 75 years old (patients is older than 18.0 and less than 75.0 years old) 2. Signed informed consent form 3. Ability to comply with the study protocol 4. Relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL):
- 8. Alanine aminotransferase (ALT) ≤5 times the upper limit of normal for age 9. Bilirubin ≤2 x ULN 10. Patients with good renal function defined as Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 cc/min.
- 11. Absolute Neutrophil Count (ANC): Patients must have an ANC ≥ 1.0 x 109
- /L without the use of growth factors 12. Platelet Count: Patients must have a platelet count ≥ 50 x 109/L without transfusion support within 7 days of screening.
- 13. Absolute Lymphocyte Count: Patients must have an absolute lymphocyte count ≥ 0.5 x 109/L.
Key exclusion criteria (40 listed)
- Clinically Active central nervous system (CNS) involvement by malignancy
- History or presence of uncontrolled underlying seizure disorder not related to B-ALL
- History of or active clinically significant cardiovascular dysfunction, including any of the following:
- Creatinine clearance < 60
- Concomitant genetic syndromes associated with Bone Marrow (BM) failure states, such as Fanconi anemia, Kostmann syndrome, Schwachman syndrome, or any other BM failure syndrome; patients with Down syndrome are not excluded
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 |
|---|---|---|
| CAR T cells chimeric antigen receptor cellsCAR T Cells | Other | single arm dose finding |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: throughout study completion, Day1 to 5 years
To assess the maximum tolerated dose, safety and tolerability of intravenous infusion of CD19 CAR T cells using based on incidence, nature, and severity of AEs graded according to National Cancer Institute Common Terminology Criteria for Adverse Events, version 5 (NCI CTCAE v5), cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS).
11 secondary outcomes
Evaluate the success rate of product manufacturing
Time frame: Pre-infusion
preliminary anti-tumor activity of CD19 CAR T cells in treated patients
Time frame: Day30 and Day 60
Safety of CD19 CAR T cells
Time frame: Day 1- 8, Day 14-21, Day30, Day60, Day90, Day120, Day180, Day270, and yearly
Safety of CD19 CAR T cells
Time frame: Day 1- 8, Day 14-21, Day30, Day60, Day90, Day120, Day180, Day270, and yearly]
safety of CD19 CAR T cells
Time frame: Day 1- 8, Day 14-21, Day30, Day60, Day90, Day120, Day180, Day270, and yearly
To characterize the pharmacokinetic (PK) profile of CD19 CAR T cells
Time frame: Day7, Day14, Day28, 2month, 4 month, 6month,10month,12month 14month,16month,18month,20month, 22month, and 24month
To characterize the pharmacokinetic (PK) profile of CD19 CAR T cells
Time frame: Day7, Day14, Day28, 2month, 4 month, 6month,10month,12month 14month,16month,18month,20month, 22month, and 24month
To characterize the pharmacokinetic (PK) profile of CD19 CAR T cells
Time frame: Day7, Day14, Day28, 2month, 4 month, 6month,10month,12month 14month,16month,18month,20month, 22month, and 24month
To characterize the pharmacokinetic (PK) profile of CD19 CAR T cells
Time frame: Day7, Day14, Day28, 2month, 4 month, 6month,10month,12month 14month,16month,18month,20month, 22month, and 24month
To characterize the pharmacokinetic (PK) profile of CD19 CAR T cells
Time frame: Day7, Day14, Day28, 2month, 4 month, 6month,10month,12month 14month,16month,18month,20month, 22month, and 24month
To characterize the pharmacokinetic (PK) profile of CD19 CAR T cells
Time frame: Day7, Day14, Day28, 2month, 4 month, 6month,10month,12month 14month,16month,18month,20month, 22month, and 24month
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 22 Jan 2026.
- Individual participant dataSharing planned: Yes. yes with Miltenyi our collaborator
Related trials for Relapsed Refractory Acute Lymphoblastic Leukemia
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
Active, not recruitingPhase 2
Valemetostat Tosylate (DS-3201b), an Enhancer of Zeste Homolog (EZH) 1/2 Dual Inhibitor, for Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01)
Relapsed/Refractory Peripheral T-Cell Lymphoma, Adult T Cell Leukemia/Lymphoma
RecruitingPhase 1
A Phase I Dose Finding Study of MB-CART2219.1
Lymphoma, CLL
RecruitingPhase 1
In VIVO CAR-T Therapy for Relapsed/Refractory Hematological Malignancies
B-Acute Lymphoblastic Leukemia, B Cell Non-Hodgkin's Lymphoma
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 CAR T cells chimeric antigen receptor cells in people with Relapsed Refractory Acute Lymphoblastic Leukemia, run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.
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 19 inclusion and 40 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 22 Jan 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 Saudi Arabia. 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 Riad El Fakih (00966539056287, relfakih1@kfshrc.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 (time frame: throughout study completion, Day1 to 5 years). 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 22 Jan 2026.