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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)
EU CTIS ID: 2023-509723-41-00
What this study is testing
In this umbrella trial, we will determine in parallel within independent cohorts: 1- 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 cell precursor ALL. 2- The safety and feasibility of allogeneic CART-NKG2D T in children, adolescents and young adults with r/r T-ALL.
- Human Pharmacology (Phase I)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age: Patients <30 years at diagnosis and/or relapse.
- Lansky (age <16 years) or Karnofsky (age ≥16 years) score of 50 or greater.
- Life expectancy greater than 12 weeks.
- 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.
You likely can't join if
- 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).
See the full eligibility criteria
Who can join
- Age: Patients <30 years at diagnosis and/or relapse.
- Lansky (age <16 years) or Karnofsky (age ≥16 years) score of 50 or greater.
- Life expectancy greater than 12 weeks.
- 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.
- Patient or patient's legal representative, parent(s), or guardian able to provide written informed consent.
- Diagnosis: o 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. / o 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 SOP).
What rules you out
- 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).
- 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. 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 -About_HMA/Working_Groups/CTFG/2014_09_HMA_CTFG_Contraception.pdf): o Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal) o Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable) o Intrauterine device (IUD) o Intrauterine hormone-releasing system o Bilateral tubal occlusion o Vasectomized partner (provided that partner is the sole sexual partner of the trial participant and that the vasectomized partner has received medical assessment of the surgical success) o 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 for at least 12 months after the infusion and until CAR-T cells are no longer present on two consecutive tests.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.