Precursor Cell Lymphoblastic Leukemia-LymphomaPhase 1REALL_CARTNCT06709469
Phase I Clinical Trial of CART Cell Therapy for Refractory/Relapsed Acute Lymphoblastic Leukemia in Children, Adolescents and Young Adults
A Phase 1 study testing Autologous CD19/CD22 CAR T cells and Allogeneic CART-NKG2D cells in people with Precursor Cell Lymphoblastic Leukemia-Lymphoma, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
Trial summary
The goal of this clinical trial is to test the feasibility and safety of an academic production of two different anti-CD19 chimeric antigen receptor T cells (CART) products according to the different biomarkers of the disease in children and young adults with relapsed/refractory CD19+ B cell acute lymphoblastic… Read more about this study
- Who is it for?
- Ages Up to 30 years
- Conditions the study is for
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- What is being tested?
- Autologous CD19/CD22 CAR T cells and Allogeneic CART-NKG2D cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- 8 Jul 2025to 1 Dec 2030
- 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 Up to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- ARM A: CD19+/- CD22+ B-ALL with relapsed or refractory disease not responding to conventional chemotherapy and with no other curative therapy available. Treatment with previous CART CD19 therapy is permitted, but is not mandatory, OR:
- ARM B: T-ALL with relapsed or refractory disease not responding to conventional chemotherapy and with no other curative therapy available.
- Patients diagnosed with ALL must be suitable for allogeneic HSCT and willing to proceed to transplant if the CART treatment induces complete remission and the investigator believes it is the best option.
- For ARM B there must be a suitable haploidentical donor (following local standard operating procedures).
- Lansky (age <16 years) or Karnofsky (age ≥16 years) score of 50 or greater.
- Life expectancy greater than 12 weeks.
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- Absolute neutrophil count (ANC) ≥ 500/μL unless, in the opinion of the investigator, cytopenia is due to underlying leukemia and is potentially reversible with leukemia therapy.
- Platelet count ≥ 50,000/μL unless, in the opinion of the investigator, cytopenia is due to underlying leukemia and is potentially reversible with leukemia therapy.
- Absolute lymphocyte count ≥ 100/μL.
- Adequate renal, hepatic, pulmonary, and cardiac function.
- Adequate venous access and absence of contraindications for lymphoapheresis
- Patients with a seizure disorder may be enrolled if well controlled with anticonvulsants.
- Patients or patients' legal representative, parent(s), or guardian able to provide written informed consent.
Who cannot join
- Enrolled in another clinical trial in the previous 4 weeks.
- Active infection requiring systemic medical therapy including clinically significant viral infection or uncontrolled viral reactivation of EBV, CMV, adenovirus, BK-virus, HHV-6 or Aspergillus.
- Any of the following cardiac criteria: cardiac echocardiography with LVSF<30% or LVEF<40%; or clinically significant pericardial effusion.
- Presence of CNS-3 disease or uncontrolled seizure disorder.
- Active immunosuppressive therapy with the exception of prednisone 10 mg/day (or equivalent), within 7 days prior to enrolment.
- GFR <30 ml/min or bilirubin >3 times the upper limit of normality (unless due to Gilbert's syndrome).
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- Any other condition that, in the opinion of the PI, may interfere with the efficacy and/or safety evaluation of the trial.
- Pregnant or lactating women.
- Sexually active patients must be willing to utilize one of the more effective birth control methods for at least 12 months after the infusion and until CAR-T cells are no longer present on two consecutive tests. Male partner should use a condom. Women of child-bearing potential are defined as all women physiologically capable of becoming pregnant.
- Sexually active males should use a condom during intercourse for at least 12 months after the infusion and until CAR-T cells are no longer present on two consecutive tests.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario La Paz
Madrid, Madrid, 28046
Antonio Pérez Martínez, MD, 917 27 75 76, aperezmartinez@salud.madrid.org
About this study
Official title: A Phase I Clinical Trial of CART Cell Therapy for Refractory/ Relapsed Acute Lymphoblastic Leukemia With Unmet Needs in Children, Adolescents and Young Adults: Feasibility and Safety Study (REALL_CART).
The goal of this clinical trial is to test the feasibility and safety of an academic production of two different anti-CD19 chimeric antigen receptor T cells (CART) products according to the different biomarkers of the disease in children and young adults with relapsed/refractory CD19+ B cell acute lymphoblastic leukemia (r/r B-ALL) or relapsed/refractory T-cell acute lymphoblastic leukemia (r/r T-ALL). The main questions it aims to answer are:
- The safety and feasibility of autologous CART-19/22 in children, adolescents and young adults with a CD19+/- CD22+ relapse/ refractory disease for a r/r B-ALL.
- The safety and feasibility of allogeneic CART-NKG2D (chimeric-antigen receptor Natural-killer group 2, member D) in children, adolescents and young adults with r/r T-ALL.
Read the detailed description
Incredible progress has been made in the treatment of relapsed/refractory CD19+ acute lymphoblastic leukemia (r/r ALL) by the application of anti-CD19 chimeric antigen receptor (CAR) T cells (CART19). However, equivalent progress has not been achieved in the treatment of relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL). Furthermore and although the majority of patients with CD19+ r/r ALL respond to CART19, 30-60% of patients relapse after this treatment, probably due to the short persistence of CAR T-cells and the immune escape or down-regulation of CD19 antigen. Patients with relapsed ALL after CART19 have a very poor prognosis and novel treatment approaches are urgently needed. To date, both relapse after CART19 malignancies and T-ALL represent an unmet medical need where no effective or targeted therapies currently exist. Recently, we and other groups have reported how T-ALL and acute myeloid leukemia (AML) cell lines were more sensitive to CART-NKG2D (chimeric-antigen receptor Natural-killer group 2, member D) cytotoxicity than B-ALL cell lines. We have previous experience in the production and administration, under compassionate use, of CART cells targeting dual CD19/CD22 antigens and NKG2D ligands. In this context, this phase I clinical trial is designed to test the feasibility and safety of an academic production of two different CART products according to the different biomarkers of the disease.
In the present study (ReALL_CART), we propose an umbrella design methodology using autologous dual CART-19/22 for CD19+/-CD22+/- relapse after CART19 or allogeneic CART-NKG2D for NKG2DL+ r/r T-ALL.
- Being tested
- Autologous CD19/CD22 CAR T cells, Allogeneic CART-NKG2D cells
- 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.
Autologous CD19/CD22 CAR T cellsBiological
A total of two doses of autologous CD19/CD22 CAR T cells (first dose of up to 0.75x106/kg fresh cells), and a second infusion of unfrozen cells (same dose) if there has been no ≥ grade 1 cytokine-release syndrome (CRS) in the next 72 h; intravenously.
Allogeneic CART-NKG2D cellsBiological
A total of up to 3x106/kg allogeneic CART-NKG2D cells divided in three doses of up to 1x106/kg will be infused; intravenously. First infusion of fresh cells, and the 2nd and 3rd infusion of unfrozen cells (same dose) if there has been no ≥ grade 1 CRS (every 48 hours).
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Children and young adults with CD19+/- CD22+ B-ALL with relapsed or refractory disease not responding to conventional chemotherapy and with no other curative therapy available. Receives: Biological: Autologous CD19/CD22 CAR T cells |
| Arm B | Experimental | Children and youn adults with T-ALL with relapsed or refractory disease not responding to conventional chemotherapy and with no other curative therapy available. Receives: Biological: Allogeneic CART-NKG2D cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events in patients that received autologous CART-19/22
An adverse event is any harmful and unintended reaction to an investigational medicinal product, regardless of the dose administered.
Adverse events will be assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, with the exception of CRS and ICANS, which will be graded according to ASBMT Consensus Grading. If CTCAE grading does not exist for an AE, the severity of mild, moderate, severe, life-threatening and fatal, corresponding to Grades 1-5, will be used.
Measured: Through study completion, an average of 5 years
Incidence and severity of adverse events in patients that received allogenic CART-NKG2D T
An adverse event is any harmful and unintended reaction to an investigational medicinal product, regardless of the dose administered.
Adverse events will be assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, with the exception of CRS and ICANS, which will be graded according to ASBMT Consensus Grading. If CTCAE grading does not exist for an AE, the severity of mild, moderate, severe, life-threatening and fatal, corresponding to Grades 1-5, will be used.
Measured: Through study completion, an average of 5 years
Secondary outcomes (6)
Expression of CD19/CD22 and NKG2DL on primary B- or T- cell ALL, respectively
The expression of CD19/CD22 and NKG2DL on primary B and T cell malignancies will be measured, respectively, by flow cytometry.
Measured: Through study completion, an average of 5 years
Persistence of CART19/22 and CART-NKG2D cells in patients' samples
The persistance of CART19/22 and CART-NKG2D cells in patients' blood, bone marrow and cerebrospinal fluid samples will be measured
Measured: Through study completion, an average of 5 years
Cytokine profile
Peripheral blood cytokine profile from the patients' serum. The following cytokines will be analysed: IFN-γ, TNF-α, GMCSF, IL-2, IL-1ß, IL-6, IL-8, IL-10, IL12
Measured: Through study completion, an average of 5 years
DNA methylation profile of NKG2DL
Identify the DNA methylation profile of NKG2DL (MICA, MICB AND ULBPs 1-3) in primary T-cell malignancies' samples. This outcome will only be measured in arm B.
Measured: Through study completion, an average of 5 years
Presence of soluble NKG2DL, and ANTI-MICA and ANTI-MICB antibodies
Evaluate the presence of soluble NKG2DL and ANTI-MICA and ANTI-MICB antibodies in the serum of patients under CART-NKG2D therapy. This outcome will only be measured in arm B.
Measured: Through study completion, an average of 5 years
Overall rate response in both arms
Response assessment will be measured by bone marrow aspirate (or trephine in case of dry tap).
Measured: Through study completion, an average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start8 Jul 2025
- Primary completion1 Jun 2030 (estimated)
- Study completion1 Dec 2030 (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 Precursor Cell Lymphoblastic Leukemia-LymphomaStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Phase I, open label, prospective, single center, two-armed, non-randomized trial
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06709469
- Sponsor's protocol ID
- HULP 6614
- Acronym
- REALL_CART
- Status last verified
- Sep 2025
- First submitted
- 21 Nov 2024
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gonzalez-Martinez B, Galan-Gomez V, Navarro-Zapata A, Mirones-Aguilar I, Cobo M, Pernas-Sanchez A, Vallejo S, Sanchez-Zapardiel E, Leon-Triana O, Echecopar C, Martinez-Romera I, Guerra-Garcia P, San Roman-Pacheco S, Escudero A, Izquierdo E, Izquierdo M, Naharro S, Martin-Ayuso A, Bareke H, Paris-Munoz A, Hu P, Schneider D, Orentas RJ, Minguillon J, Perez-Martinez A. Tandem CD19/CD22 CAR T-cells as potential therapy for children and young adults with high-risk r/r B-ALL. EBioMedicine. 2025 Aug;118:105872. doi: 10.1016/j.ebiom.2025.105872. Epub 2025 Aug 5.
PubMed 40753722
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial of CART Cell Therapy for Refractory/ Relapsed Acute Lymphoblastic Leukemia With Unmet Needs in Children, Adolescents and Young Adults: Feasibility and Safety Study (REALL_CART).
- ClinicalTrials.gov ID
- NCT06709469
- Acronym / sponsor ID
- REALL_CART / HULP 6614
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Study start
- 8 Jul 2025 (actual)
- Primary completion
- 1 Jun 2030 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 29 Nov 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.
The goal of this clinical trial is to test the feasibility and safety of an academic production of two different anti-CD19 chimeric antigen receptor T cells (CART) products according to the different biomarkers of the disease in children and young adults with relapsed/refractory CD19+ B cell acute lymphoblastic leukemia (r/r B-ALL) or relapsed/refractory T-cell acute lymphoblastic leukemia (r/r T-ALL). The main questions it aims to answer are:
- The safety and feasibility of autologous CART-19/22 in children, adolescents and young adults with a CD19+/- CD22+ relapse/ refractory disease for a r/r B-ALL.
- The safety and feasibility of allogeneic CART-NKG2D (chimeric-antigen receptor Natural-killer group 2, member D) in children, adolescents and young adults with r/r T-ALL.
Detailed description
Incredible progress has been made in the treatment of relapsed/refractory CD19+ acute lymphoblastic leukemia (r/r ALL) by the application of anti-CD19 chimeric antigen receptor (CAR) T cells (CART19). However, equivalent progress has not been achieved in the treatment of relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL). Furthermore and although the majority of patients with CD19+ r/r ALL respond to CART19, 30-60% of patients relapse after this treatment, probably due to the short persistence of CAR T-cells and the immune escape or down-regulation of CD19 antigen. Patients with relapsed ALL after CART19 have a very poor prognosis and novel treatment approaches are urgently needed. To date, both relapse after CART19 malignancies and T-ALL represent an unmet medical need where no effective or targeted therapies currently exist. Recently, we and other groups have reported how T-ALL and acute myeloid leukemia (AML) cell lines were more sensitive to CART-NKG2D (chimeric-antigen receptor Natural-killer group 2, member D) cytotoxicity than B-ALL cell lines. We have previous experience in the production and administration, under compassionate use, of CART cells targeting dual CD19/CD22 antigens and NKG2D ligands. In this context, this phase I clinical trial is designed to test the feasibility and safety of an academic production of two different CART products according to the different biomarkers of the disease.
In the present study (ReALL_CART), we propose an umbrella design methodology using autologous dual CART-19/22 for CD19+/-CD22+/- relapse after CART19 or allogeneic CART-NKG2D for NKG2DL+ r/r T-ALL.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase I, open label, prospective, single center, two-armed, non-randomized trial
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Biological: Autologous CD19/CD22 CAR T cellsChildren and young adults with CD19+/- CD22+ B-ALL with relapsed or refractory disease not responding to conventional chemotherapy and with no other curative therapy available. |
| Arm B | Experimental | Biological: Allogeneic CART-NKG2D cellsChildren and youn adults with T-ALL with relapsed or refractory disease not responding to conventional chemotherapy and with no other curative therapy available. |
Who may qualify
- Ages
- Up to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- ARM A: CD19+/- CD22+ B-ALL with relapsed or refractory disease not responding to conventional chemotherapy and with no other curative therapy available. Treatment with previous CART CD19 therapy is permitted, but is not mandatory, OR:
- ARM B: T-ALL with relapsed or refractory disease not responding to conventional chemotherapy and with no other curative therapy available.
- Patients diagnosed with ALL must be suitable for allogeneic HSCT and willing to proceed to transplant if the CART treatment induces complete remission and the investigator believes it is the best option.
- For ARM B there must be a suitable haploidentical donor (following local standard operating procedures).
- Lansky (age <16 years) or Karnofsky (age ≥16 years) score of 50 or greater.
Key exclusion criteria (10 listed)
- Enrolled in another clinical trial in the previous 4 weeks.
- Active infection requiring systemic medical therapy including clinically significant viral infection or uncontrolled viral reactivation of EBV, CMV, adenovirus, BK-virus, HHV-6 or Aspergillus.
- Any of the following cardiac criteria: cardiac echocardiography with LVSF<30% or LVEF<40%; or clinically significant pericardial effusion.
- Presence of CNS-3 disease or uncontrolled seizure disorder.
- Active immunosuppressive therapy with the exception of prednisone 10 mg/day (or equivalent), within 7 days prior to enrolment.
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 |
|---|---|---|
| Autologous CD19/CD22 CAR T cellsA total of two doses of autologous CD19/CD22 CAR T cells (first dose of up to 0.75x106/kg fresh cells), and a second infusion of unfrozen cells (same dose) if there has been no ≥ grade 1 cytokine-release syndrome (CRS) in the next 72 h; intravenously. | Biological | Arm A |
| Allogeneic CART-NKG2D cellsA total of up to 3x106/kg allogeneic CART-NKG2D cells divided in three doses of up to 1x106/kg will be infused; intravenously. First infusion of fresh cells, and the 2nd and 3rd infusion of unfrozen cells (same dose) if there has been no ≥ grade 1 CRS (every 48 hours). | Biological | Arm B |
Primary outcome
Incidence and severity of adverse events in patients that received autologous CART-19/22
Time frame: Through study completion, an average of 5 years
An adverse event is any harmful and unintended reaction to an investigational medicinal product, regardless of the dose administered. Adverse events will be assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, with the exception of CRS and ICANS, which will be graded according to ASBMT Consensus Grading. If CTCAE grading does not exist for an AE, the severity of mild, moderate, severe, life-threatening and fatal, corresponding to Grades 1-5, will be used.
Incidence and severity of adverse events in patients that received allogenic CART-NKG2D T
Time frame: Through study completion, an average of 5 years
An adverse event is any harmful and unintended reaction to an investigational medicinal product, regardless of the dose administered. Adverse events will be assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, with the exception of CRS and ICANS, which will be graded according to ASBMT Consensus Grading. If CTCAE grading does not exist for an AE, the severity of mild, moderate, severe, life-threatening and fatal, corresponding to Grades 1-5, will be used.
6 secondary outcomes
Expression of CD19/CD22 and NKG2DL on primary B- or T- cell ALL, respectively
Time frame: Through study completion, an average of 5 years
Persistence of CART19/22 and CART-NKG2D cells in patients' samples
Time frame: Through study completion, an average of 5 years
Cytokine profile
Time frame: Through study completion, an average of 5 years
DNA methylation profile of NKG2DL
Time frame: Through study completion, an average of 5 years
Presence of soluble NKG2DL, and ANTI-MICA and ANTI-MICB antibodies
Time frame: Through study completion, an average of 5 years
Overall rate response in both arms
Time frame: Through study completion, an average of 5 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 22 Sep 2025.
- Derived from this study: PubMed 40753722Gonzalez-Martinez B, Galan-Gomez V, Navarro-Zapata A, Mirones-Aguilar I, Cobo M, Pernas-Sanchez A, Vallejo S, Sanchez-Zapardiel E, Leon-Triana O, Echecopar C, Martinez-Romera I, Guerra-Garcia P, San Roman-Pacheco S, Escudero A, Izquierdo E, Izquierdo M, Naharro S, Martin-Ayuso A, Bareke H, Paris-Munoz A, Hu P, Schneider D, Orentas RJ, Minguillon J, Perez-Martinez A. Tandem CD19/CD22 CAR T-cells as potential therapy for children and young adults with high-risk r/r B-ALL. EBioMedicine. 2025 Aug;118:105872. doi: 10.1016/j.ebiom.2025.105872. Epub 2025 Aug 5.
- 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 Autologous CD19/CD22 CAR T cells and Allogeneic CART-NKG2D cells in people with Precursor Cell Lymphoblastic Leukemia-Lymphoma, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
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 13 inclusion and 10 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 Sep 2025. 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 Spain. 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 Antonio Pérez Martínez, MD (917 27 75 76, aperezmartinez@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events in patients that received autologous CART-19/22 (time frame: Through study completion, an average of 5 years). 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 NCT06709469, 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 22 Sep 2025.