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).

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509723-41-00

Acronym

REALL_ CART

Enrollment

Registered

2024-05-07

Start date

Unknown

Completion date

Unknown

Last updated

2024-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

adolescents and young adults., Refractory/ relapsed acute lymphoblastic leukemia in children

Brief summary

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-ALL. 2- The safety and feasibility of allogeneic CART-NKG2D T in children, adolescents and young adults with r/r T-ALL.

Detailed description

Expression of CD19/CD22 and NKG2DL on primary B- or T- cell ALL, respectively., Persistence of CART19/22 and CARTs-NKG2D cells in patients’ samples (peripheral blood, bone marrow, cerebrospinal fluid)., Peripheral blood cytokine profile from the patients’ serum., Identify the DNA methylation profile of NKG2DL (MICA, MICB AND ULBPs 1-3) in primary T-cell malignancies’ samples., Evaluate the presence of soluble NKG2DL and ANTI-MICA and ANTI-MICB antibodies in the serum of patients under CART-NKG2D therapy., Overall rate response in both arms.

Interventions

DRUGCART45RA-NKG2D CELLS

DRUGCART 19/22 T CELLS

Eligibility

Sex/Gender

All

Age

0 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
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-ALL. 2- The safety and feasibility of allogeneic CART-NKG2D T in children, adolescents and young adults with r/r T-ALL.	—

Secondary

Measure	Time frame
Expression of CD19/CD22 and NKG2DL on primary B- or T- cell ALL, respectively., Persistence of CART19/22 and CARTs-NKG2D cells in patients’ samples (peripheral blood, bone marrow, cerebrospinal fluid)., Peripheral blood cytokine profile from the patients’ serum., Identify the DNA methylation profile of NKG2DL (MICA, MICB AND ULBPs 1-3) in primary T-cell malignancies’ samples., Evaluate the presence of soluble NKG2DL and ANTI-MICA and ANTI-MICB antibodies in the serum of patients under CART-NKG2D therapy., Overall rate response in both arms.	—

Measure

Time frame

—

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026