Advanced SarcomaPhase 1CAR4SARNCT06087341
A Phase I Trial of Memory T Cells Expressing an NKG2D Chimeric Antigen Receptor in Children, Adolescents and Young Adults With Advanced Sarcoma
A Phase 1 study testing NKG2D-CAR memory T cell in people with Advanced Sarcoma, run by Antonio Pérez Martínez at 1 site in Spain.
Trial summary
Phase I, open label, prospective, single-center, non-randomized, dose escalation clinical trial aiming to determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of systemic transduced donor-derived NKG2D-CAR memory T cell infusions (Arm A), and of dual treatment, with both systemic and locally… Read more about this study
- Who is it for?
- Ages Up to 30 years
- Conditions the study is for
- Advanced Sarcoma
- What is being tested?
- NKG2D-CAR memory T cell
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jan 2024to Apr 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 Up to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age: ≤ 40 years at the time of recurrence or progression with any type of sarcoma that has recurred or not responded to standard therapy and is deemed incurable by standard therapy.
- Positive NKG2DL expression in sarcoma samples. Ideally, they should have centralized histological verification of NKG2DL expression in sarcoma samples (positive expression is defined as at least 2+ expression (0-4+ scale) in >50 percent of the tumor cells using anti-MICA and or anti-ULBP2). Patients will undergo biopsy following enrollment to obtain tissue to assess NKG2DL expression, with the following restrictions:
- If the patient doesn´t have adequate accessible tumor for biopsy (at least 1 cm diameter).
- Procedures employed to acquire biopsies for tumor lysates will be limited to percutaneous needle or core biopsies, thoracoscopic excision or open biopsies of readily accessible lesions. Pulmonary lesions may be biopsied but extensive surgery such as thoracotomy or laparotomy should not be employed.
- Patients who require biopsy should not be enrolled if in the opinion of the principal investigator (PI), the tumor site places the patient at substantial related risk from the biopsy procedure.
- In patients that fulfill any of these restrictions, when adequate archived tissue is available, this may be utilized to assess NKG2DL expression.
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- Patient must have either measurable or evaluable tumor.
- The tumor must be accessible for intralesional administration of CAR T cells (only in ARM B).
- Life expectancy of at least 10 weeks in opinion of the principal investigator (PI).
- Lansky (age <16 years) or Karnofsky (age >=16 years) score of 50 or greater.
- Patients must have recovered from the acute toxic effects of all prior anticancer therapy (including chemotherapy and radiotherapy).
- Adequate bone marrow function defined by an absolute neutrophil count (ANC) of >/= 1.000/μL, platelet count of >/= 30.000/μL and hemoglobin of >/= 9.0 g/dl, and absence of a regular red blood cell and platelet transfusion requirement.
- Patients should have a normal hepatic function with a total bilirubin <2 times the upper limit of normal and serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) < 2 times the upper limit of normal, and adequate renal function as defined by a serum creatinine ≤ 1.5 upper limit of normal.
- Patient or patient's legal representative, parent(s), or guardian able to provide written informed consent.
- Sexually active patients must be willing to utilize one of the more effective birth control methods for 6 months after the infusion. Male partner should use a condom.
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study treatment and for at least 6 months after the NKG2D-CAR T infusion and until CAR-T cells are no longer present by qPCR on two consecutive tests. Highly effective contraception methods include, as defined by the CTFG recommendations (available at h t t p s : / / w w w . h m a . e u / f i l e a d m i n / d a t e i e n / H u m a n M e d i c i n e s / 0 1 -AboutHMA/WorkingGroups/CTFG/201409HMACTFGContraception.pdf):
- Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)
- Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
- Intrauterine device (IUD)
- Intrauterine hormone-releasing system
- Bilateral tubal occlusion
- Vasectomised partner (provided that partner is the sole sexual partner of the trial participant and that the vasectomised partner has received medical assessment of the surgical success)
- Sexual abstinence (only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject).
- Sexually active males should use a condom during intercourse while taking study treatment and for at least 6 months after the infusion and until CAR-T cell are no longer present by qPCR on two consecutive tests.
Who cannot join
- Enrolled in another treatment protocol.
- Evidence of untreated and active infection or clinically significant systemic illness:
- Cardiac disorder defined as LVFE < 45% determined by ECHO.
- Human Immunodeficiency Virus (HIV) positive test.
- Presence of active or prior CMV, EBV, hepatitis B or C as indicated by serology.
- Any significant pulmonary, hepatic or other organ dysfunction.
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- Chronic corticosteroid dependence (except replacement therapy).
- Evidence of any toxicity grade ≥ 4 (according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0).
- Pregnant or lactating women.
- Medical history of epilepsy.
- Any other condition that, in the opinion if the PI, may interfere with the efficacy and/or safety evaluation of the trial.
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, 442944
Antonio Pérez Martínez, MD
About this study
Phase I, open label, prospective, single-center, non-randomized, dose escalation clinical trial aiming to determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of systemic transduced donor-derived NKG2D-CAR memory T cell infusions (Arm A), and of dual treatment, with both systemic and locally transduced donor-derived NKG2D-CAR memory T cell infusions (Arm B).
Read the detailed description
Childhood cancer is considered a rare disease based on prevalence. Despite this, in developed countries, cancer is the most common cause of disease-related death in the pediatric population. Sarcomas are a rare and heterogeneous group of malignant tumors of mesenchymal origin representing around 10% of pediatric cancers. For patients with standard-risk and localized disease, survival is 70-80%. However, for those patients with high-risk disease, or those who relapse or develop metastases, the survival rate is only 30%. Current treatment consisting in local surgery, radiotherapy and poly-chemotherapy remains ineffective in advanced stages or relapse and is associated with acute and chronic adverse effects which compromise survival and quality of life. Thus, there is an urgent need to find new therapeutic alternatives in order to improve the outcome in sarcoma patients. Different groups have described the importance of NKG2D receptor and NKG2D ligands (NKG2DL) in sarcoma immunosurveillance. Tumor cells are recognized and eliminated by the immune surveillance system. A master key receptor called NKG2D is critical to induce cancer control. Recently, this group has published how this receptor can recognize and target most childhood cancers including sarcoma. Although different cells from the surveillance system possess this receptor, cancer cells can block their ability to recognize and eliminate the tumor cells. NKG2D CAR receptor induces tumor-specific lysis, is safe to normal cells and provides effector cells the ability to bypass the mechanisms of resistance induced by tumor cells. In the present study the investigators aim to analyze the safety of an NKG2D-CAR T cell therapy in pediatric, adolescent and young adult (AYA) patients suffering from advanced sarcoma. In a recent preclinical study developed by this group, the investigators demonstrated the efficacy and safety of an NKG2D-CAR T cell-based therapy for osteosarcoma. Furthermore, in this hospital, NKG2D-CAR T cells have been already produced in a GMP-environment and infused in two pediatric patients as compassionate use, and no signs of treatment-related toxicity have been observed. In the present study, the investigators aim to develop a dose escalation Phase I trial of NKG2D chimeric antigen receptor-T cells (NKG2D-CAR T) to assess the safety and clinical activity in pediatric patients with advanced sarcoma. This clinical trial proposal is the continuation of a previous research project funded by the Asociación Española Contra el Cáncer (AECC) in 2016, which was the first AECC funded project on CAR T cell therapy in children with metastatic disease.
- Conditions
- Advanced Sarcoma
- Being tested
- NKG2D-CAR memory T cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NKG2D-CAR memory T cellOther
Patients will be allocated in two groups: Arm A and Arm B. Both groups will receive an intravenous infusion of NKG2D-CAR memory T cells. Additionally, patients on Arm B will receive an intratumoral dose of NKG2D-CAR memory T cells (in accessible primary tumor and metastases). The distribution of patients on one arm or other will depend on their clinical characteristics described in the inclusion/ exclusion criteria. All patients will receive lymphodepleting chemotherapy prior to the infusion of NKG2D-CAR memory T cells according to the usual clinical practice in our center. Some patients will also receive low dose radiotherapy prior to infusion.
| Study group | Role | What they receive |
|---|---|---|
| NKG2D-CAR memory T cells infusion | Experimental | If the primary tumor and/or metastases are not accessible, the patient will be included in Arm A.This group will receive an intravenous infusion of NKG2D-CAR memory T cells. Receives: Other: NKG2D-CAR memory T cell |
| Systemic and locally transduced NKG2D-CAR memory T cells infusion | Experimental | If the primary tumor and/or metastases are accessible, the patient will be included in Arm B. This group will receive an intravenous infusion of NKG2D-CAR memory T cells and an intratumoral dose of NKG2D-CAR memory T cells. Receives: Other: NKG2D-CAR memory T cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Dose-limiting toxicity (DLT) of NKG2D-CAR memory T cells
- Any grade 3 or higher toxicity with an attribution of definitely or probably related to the infusion of the NKG2D CAR-T cells with the exception of Grade 3 fever and immediate hypersensitivity reactions occurring within 2hours of cell infusion that are reversible to a Grade 2 or less within 24 hours of cell administration with standard therapy;
- Any lower grade toxicity that increases to a grade 3 or higher as a direct result of the NKG2D CAR-T cell infusion.
Measured: During the study treatment, until 28 days after the last study iv treatment administration
Safety: Maximum Tolerated Dose (MTD) of NKG2D-CAR memory T cells
The highest dose level if no Dose-limiting toxicitys are observed
Measured: During the study treatment, until 28 days after the last study iv treatment administration
Response rate
This outcome will be evaluated by Immune-Related Response Criteria (iRECIST) v1.1.
The efficacy will be measured by objective response rate (ORR) at D60 in both arms, which includes Complete Response (CR) and Partial Response (PR) based on Immune-Related Response Criteria iRECIST v1.1.
Measured: At day 60 after the treatment
Secondary outcomes (7)
Rate of NKG2D-CAR T cells persistence in peripheral blood
Number of Arm A and Arm B subjects with persistence of NKG2D-CAR T cells in peripheral blood at screening and then starting from D1.
Measured: During 12 months after the treatment
Rate of NKG2D-CAR T cells persistence in the tumor and metastasis site
Number of Arm A and Arm B subjects with persistence of NKG2D-CAR T cells in the tumor samples at biopsy times (D21 and D60).
Measured: 21 and 60 days after the treatment
Rate of NKG2DL positive expression on primary sarcoma samples
Number of Arm A and Arm B subjects with persistence of NKG2D-CAR T cells in peripheral blood at D21 and D60.
Measured: 21 and 60 days after the treatment
Cytokine determination in the serum of patients
Obtain primary patient-derived cancer cells from accessible sarcomas
Measured: During 12 months after the treatment
Analysis of patient peripheral blood immune cell subpopulations
Identify the immune cell phenotypes linked to CAR-T expansion and response provides an opportunity to understand the mechanisms of CAR-T success and craft approaches to improve CAR-T activity. The changes in cell differentiation stages and exhaustion markers of immune populations will be done by spectral flow cytometry.
Measured: 21 and 60 days after the treatment
Identify the DNA methylation profile of NKG2DL (MICA, MICB AND ULBPS 1-3) in primary sarcoma samples and DNA methylation profile of NKG2D-T cells before and after infusion.
Analyze the DNA methylation profile of MICA, MICB and ULBP1-3 genes in primary sarcoma samples from D0, D21 and D60, by pyrosequencing techniques.
Measured: 21 and 60 days after the treatment
Evaluate the presence of soluble NKG2DL and ANTI-MICA antibodies in the serum of patients under therapy
The presence of anti-MICA antibodies will be determined in the serum of patients obtained at different times using LABScreen assay by Luminex Technology (LABScreen TM MICA and LSA-MIC single antigen, One Lambda and Diagnostica Longwood, respectively).
Measured: During 60 days after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start10 Jan 2024
- Primary completionJan 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced SarcomaStudies 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
- Arm A: systemic transduced donor-derived NKG2D-CAR memory T cells infusion. Arm B: dual treatment, with both systemic and locally transduced donor-derived NKG2D-CAR memory T cells infusion.
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Antonio Pérez Martínez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Antonio Pérez Martínez, Instituto de Investigación Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06087341
- Sponsor's protocol ID
- CAR4SAR
- Acronym
- CAR4SAR
- Status last verified
- Apr 2024
- First submitted
- 11 Oct 2023
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of Memory T Cells Expressing an NKG2D Chimeric Antigen Receptor in Children, Adolescents and Young Adults With Advanced Sarcoma
- ClinicalTrials.gov ID
- NCT06087341
- Acronym / sponsor ID
- CAR4SAR / CAR4SAR
- Conditions
- Advanced Sarcoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Antonio Pérez MartínezUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 17 Oct 2023 (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.
Phase I, open label, prospective, single-center, non-randomized, dose escalation clinical trial aiming to determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of systemic transduced donor-derived NKG2D-CAR memory T cell infusions (Arm A), and of dual treatment, with both systemic and locally transduced donor-derived NKG2D-CAR memory T cell infusions (Arm B).
Detailed description
Childhood cancer is considered a rare disease based on prevalence. Despite this, in developed countries, cancer is the most common cause of disease-related death in the pediatric population. Sarcomas are a rare and heterogeneous group of malignant tumors of mesenchymal origin representing around 10% of pediatric cancers. For patients with standard-risk and localized disease, survival is 70-80%. However, for those patients with high-risk disease, or those who relapse or develop metastases, the survival rate is only 30%. Current treatment consisting in local surgery, radiotherapy and poly-chemotherapy remains ineffective in advanced stages or relapse and is associated with acute and chronic adverse effects which compromise survival and quality of life. Thus, there is an urgent need to find new therapeutic alternatives in order to improve the outcome in sarcoma patients. Different groups have described the importance of NKG2D receptor and NKG2D ligands (NKG2DL) in sarcoma immunosurveillance. Tumor cells are recognized and eliminated by the immune surveillance system. A master key receptor called NKG2D is critical to induce cancer control. Recently, this group has published how this receptor can recognize and target most childhood cancers including sarcoma. Although different cells from the surveillance system possess this receptor, cancer cells can block their ability to recognize and eliminate the tumor cells. NKG2D CAR receptor induces tumor-specific lysis, is safe to normal cells and provides effector cells the ability to bypass the mechanisms of resistance induced by tumor cells. In the present study the investigators aim to analyze the safety of an NKG2D-CAR T cell therapy in pediatric, adolescent and young adult (AYA) patients suffering from advanced sarcoma. In a recent preclinical study developed by this group, the investigators demonstrated the efficacy and safety of an NKG2D-CAR T cell-based therapy for osteosarcoma. Furthermore, in this hospital, NKG2D-CAR T cells have been already produced in a GMP-environment and infused in two pediatric patients as compassionate use, and no signs of treatment-related toxicity have been observed. In the present study, the investigators aim to develop a dose escalation Phase I trial of NKG2D chimeric antigen receptor-T cells (NKG2D-CAR T) to assess the safety and clinical activity in pediatric patients with advanced sarcoma. This clinical trial proposal is the continuation of a previous research project funded by the Asociación Española Contra el Cáncer (AECC) in 2016, which was the first AECC funded project on CAR T cell therapy in children with metastatic disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Arm A: systemic transduced donor-derived NKG2D-CAR memory T cells infusion. Arm B: dual treatment, with both systemic and locally transduced donor-derived NKG2D-CAR memory T cells infusion.
| Arm | Type | Receives |
|---|---|---|
| NKG2D-CAR memory T cells infusion | Experimental | Other: NKG2D-CAR memory T cellIf the primary tumor and/or metastases are not accessible, the patient will be included in Arm A.This group will receive an intravenous infusion of NKG2D-CAR memory T cells. |
| Systemic and locally transduced NKG2D-CAR memory T cells infusion | Experimental | Other: NKG2D-CAR memory T cellIf the primary tumor and/or metastases are accessible, the patient will be included in Arm B. This group will receive an intravenous infusion of NKG2D-CAR memory T cells and an intratumoral dose of NKG2D-CAR memory T cells. |
Who may qualify
- Ages
- Up to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (24 listed)
- Age: ≤ 40 years at the time of recurrence or progression with any type of sarcoma that has recurred or not responded to standard therapy and is deemed incurable by standard therapy.
- Positive NKG2DL expression in sarcoma samples. Ideally, they should have centralized histological verification of NKG2DL expression in sarcoma samples (positive expression is defined as at least 2+ expression (0-4+ scale) in >50 percent of the tumor cells using anti-MICA and or anti-ULBP2). Patients will undergo biopsy following enrollment to obtain tissue to assess NKG2DL expression, with the following restrictions:
- In patients that fulfill any of these restrictions, when adequate archived tissue is available, this may be utilized to assess NKG2DL expression.
- Patient must have either measurable or evaluable tumor.
- The tumor must be accessible for intralesional administration of CAR T cells (only in ARM B).
Key exclusion criteria (11 listed)
- Enrolled in another treatment protocol.
- Evidence of untreated and active infection or clinically significant systemic illness:
- Chronic corticosteroid dependence (except replacement therapy).
- Evidence of any toxicity grade ≥ 4 (according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0).
- Pregnant or lactating women.
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 |
|---|---|---|
| NKG2D-CAR memory T cellPatients will be allocated in two groups: Arm A and Arm B. Both groups will receive an intravenous infusion of NKG2D-CAR memory T cells. Additionally, patients on Arm B will receive an intratumoral dose of NKG2D-CAR memory T cells (in accessible primary tumor and metastases). The distribution of patients on one arm or other will depend on their clinical characteristics described in the inclusion/ exclusion criteria. All patients will receive lymphodepleting chemotherapy prior to the infusion of NKG2D-CAR memory T cells according to the usual clinical practice in our center. Some patients will also receive low dose radiotherapy prior to infusion. | Other | NKG2D-CAR memory T cells infusion, Systemic and locally transduced NKG2D-CAR memory T cells infusion |
Primary outcome
Safety: Dose-limiting toxicity (DLT) of NKG2D-CAR memory T cells
Time frame: During the study treatment, until 28 days after the last study iv treatment administration
1. Any grade 3 or higher toxicity with an attribution of definitely or probably related to the infusion of the NKG2D CAR-T cells with the exception of Grade 3 fever and immediate hypersensitivity reactions occurring within 2hours of cell infusion that are reversible to a Grade 2 or less within 24 hours of cell administration with standard therapy; 2. Any lower grade toxicity that increases to a grade 3 or higher as a direct result of the NKG2D CAR-T cell infusion.
Safety: Maximum Tolerated Dose (MTD) of NKG2D-CAR memory T cells
Time frame: During the study treatment, until 28 days after the last study iv treatment administration
The highest dose level if no Dose-limiting toxicitys are observed
Response rate
Time frame: At day 60 after the treatment
This outcome will be evaluated by Immune-Related Response Criteria (iRECIST) v1.1. The efficacy will be measured by objective response rate (ORR) at D60 in both arms, which includes Complete Response (CR) and Partial Response (PR) based on Immune-Related Response Criteria iRECIST v1.1.
7 secondary outcomes
Rate of NKG2D-CAR T cells persistence in peripheral blood
Time frame: During 12 months after the treatment
Rate of NKG2D-CAR T cells persistence in the tumor and metastasis site
Time frame: 21 and 60 days after the treatment
Rate of NKG2DL positive expression on primary sarcoma samples
Time frame: 21 and 60 days after the treatment
Cytokine determination in the serum of patients
Time frame: During 12 months after the treatment
Analysis of patient peripheral blood immune cell subpopulations
Time frame: 21 and 60 days after the treatment
Identify the DNA methylation profile of NKG2DL (MICA, MICB AND ULBPS 1-3) in primary sarcoma samples and DNA methylation profile of NKG2D-T cells before and after infusion.
Time frame: 21 and 60 days after the treatment
Evaluate the presence of soluble NKG2DL and ANTI-MICA antibodies in the serum of patients under therapy
Time frame: During 60 days after the treatment
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 12 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NKG2D-CAR memory T cell in people with Advanced Sarcoma, run by Antonio Pérez Martínez 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 24 inclusion and 11 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 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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 (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?
Safety: Dose-limiting toxicity (DLT) of NKG2D-CAR memory T cells (time frame: During the study treatment, until 28 days after the last study iv treatment administration). The study lists 3 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 12 Apr 2024.