Not yet recruitingRare disease

Phase II study of autologous enriched T‑cell therapy expressing CD19 and CD22 CARs in Philadelphia‑negative B‑precursor ALL patients with measurable residual disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study involves patients with Philadelphia negative B-precursor acute lymphoblastic leukaemia who have minimal residual disease (MRD) after initial therapy. MRD means a very small number of cancer cells that remain in the body, detectable only with highly sensitive tests. The investigational treatment is a cell‑based therapy called Obe-cel. It uses the patient’s own immune cells, specifically autologous enriched T cells, which are collected and then modified in the laboratory with a virus to add special receptors that recognize the cancer‑associated proteins CD19 and CD22. These modified cells are a type of CAR T therapy, designed to seek out and destroy any remaining leukemia cells.

The purpose of the study is to evaluate the impact of Obe-cel on event‑free survival at 12 months. Participants will receive a single infusion of the therapy after a short preparatory regimen, followed by regular clinic visits, blood tests, and bone‑marrow checks over the next two years to see whether the disease returns or any side effects occur. The study records how long patients stay free of disease events, such as relapse or death, and monitors safety.

The research process

The trial runs in 10 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment and baseline assessments
After joining the study, a consent form is signed and a series of baseline tests are performed. these include medical history review, physical examination, blood tests, and a bone‑marrow sample to measure minimal residual disease (mr d), which indicates how many cancer cells remain.
The bone‑marrow test looks for cancer‑related genetic markers at a sensitivity of at least 10⁻⁴.
Step 2
Bridging therapy (if required)
If the disease shows signs of progressing while the personalized cell product is being prepared, a short course of additional chemotherapy may be given. this is called bridging therapy and is intended to keep the disease stable until the obecel infusion can be performed.
Step 3
Lymphodepletion chemotherapy
A short chemotherapy regimen is administered to reduce the number of normal immune cells. this creates space for the infused obecel cells to expand. the regimen is given over several days according to the study protocol.
Step 4
Obecel infusion
The personalized cell product, called obecel, consists of autologous enriched t cells that have been genetically modified to target cd19 and cd22. a single dose of 310,000,000 cells is delivered by intravenous infusion.
The infusion is performed in a controlled clinical setting and lasts for the time required to deliver the full cell dose.
Step 5
Hospital monitoring after infusion
Following the infusion, the patient remains in the hospital for close observation. vital signs, blood tests, and neurological status are checked regularly to detect any signs of cytokine release syndrome (c rs) or immune effector cell‑associated neurotoxicity syndrome (i cans).
The total number of hospital days starts with the lymphodepletion regimen and continues until the medical team determines that the patient is stable.
Step 6
Day 28 follow‑up
Approximately 28 days after the obecel infusion, a follow‑up visit is scheduled. blood and bone‑marrow samples are taken to assess mr d response and to evaluate any adverse events.
The results indicate the early effectiveness of the treatment and guide further care.
Step 7
Month 3 follow‑up
Around three months (about 90 days) after the infusion, another assessment is performed. the primary goal is to determine the mr d complete response rate, meaning the proportion of patients whose bone‑marrow test shows no detectable disease.
Additional laboratory tests, including immunoglobulin levels, are measured at this time.
Step 8
Regular follow‑up visits up to 24 months
The patient attends scheduled visits at defined intervals (for example, every few months) until at least 24 months after the infusion. each visit includes physical examination, blood work, and bone‑marrow testing to monitor the durability of the mr d response.
Measurements of B‑cell numbers, immunoglobulin levels, and any need for intravenous immunoglobulin (ivig) replacement are recorded.
Any occurrence of disease relapse, new malignancy, or additional therapy such as allogeneic stem‑cell transplant is documented.
Step 9
Possible second dose of obecel
If the treating physician determines that a second infusion is necessary, the timing and reason for the delay are recorded. the second dose follows the same dosing and administration procedure as the first infusion.
Step 10
Study completion and final assessment
At the end of the study period, a final assessment is performed to evaluate long‑term outcomes such as event‑free survival, overall survival, and any late adverse events.
All collected data are analyzed to determine the overall efficacy and safety of obecel in patients with minimal residual disease.

Who can join the trial?

14 criteria

You must have a specific type of acute lymphoblastic leukemia that does not have the Philadelphia chromosome (Ph‑negative), shows the CD19 marker (CD19 positive), is in the first complete remission (CR1), and after the second round of initial treatment your tests must show minimal residual disease (MRD) of 0.01% (10⁻⁴) or higher.
Your heart must be able to pump well enough, with a left ventricular ejection fraction (LVEF) greater than 30% measured by an ultrasound of the heart.
You must test negative for the infections HIV, hepatitis B (surface antigen), hepatitis C (antibody), HTLV‑1, HTLV‑2, and syphilis.
If you are a woman who could become pregnant, you must have a negative pregnancy test.
Your pancreas function must be normal: the blood level of the enzyme lipase must be no more than 1.5 times the highest normal value; if it is a little higher (up to 3 times normal) it must not be considered a health problem and must not be linked to risk for acute pancreatitis.
Women of childbearing potential must use two highly effective birth‑control methods while receiving the study drug and for three months after the last dose; men with a female partner of childbearing potential must do the same. Highly effective methods include abstinence; hormonal methods (birth‑control pills, intrauterine device, vaginal ring, patches, implants or injections) combined with barrier methods (condoms, cervical cap, diaphragm with spermicides); or a vasectomy. Women of childbearing potential are mature women who have not had a hysterectomy, surgical sterilization, or natural menopause.
You must be able to understand the study information and be willing to sign a written informed consent form.
You must already have a signed and dated written informed consent form on file.
You must be enrolled in the German Multicenter Study Group for Adult ALL registry.
You need a specific molecular marker (gene rearrangement of IG, TR, or KMT2A‑fusion) that can be measured for MRD with a test that can detect at least 0.01% disease, performed at the central reference laboratory in Kiel.
Your overall health status must be good enough to have an ECOG performance status of less than 2 (you are able to carry out normal daily activities and are not confined to bed).
Your age must be between 55 and 75 years old, inclusive.
Your kidney function must be adequate, with a glomerular filtration rate (GFR) of at least 30 ml/min, calculated using the Cockcroft‑Gault equation.
Your liver function must be acceptable: the enzymes alanine aminotransferase (ALT) or aspartate aminotransferase (AST) must be less than six times the highest normal value, and total bilirubin must be less than three times the highest normal value.

Who cannot join the trial?

9 criteria

Having received systemic chemotherapy (medicine that spreads throughout the whole body) before the study treatment, except for the normal initial chemotherapy called induction I + II that is part of standard front‑line therapy.
Having a second cancer (malignancy) unless it is a cured cancer with no active disease for at least 2 years, no current treatment, and the doctor believes the risk of it returning is low; or an early‑stage breast or cervical cancer called carcinoma in situ; or a non‑melanoma skin cancer; or breast or prostate cancer that is only being treated with hormone (hormonal maintenance) therapy.
Having a current serious brain or nervous‑system problem such as seizures (sudden convulsions), weakness (paresis), trouble speaking (aphasia), stroke (cerebrovascular ischemia or hemorrhage), severe brain injury, dementia (memory loss), Parkinson’s disease (movement disorder), cerebellar disease (balance problems), or severe mental illness like psychosis. (A past history of these problems does not exclude you.)
Having an active autoimmune disease, which means the immune system is mistakenly attacking the body’s own tissues.
Having an active infection (fungal, bacterial, viral, or other) that requires medicines taken by mouth or IV (systemic antimicrobials) to treat.
Having taken any experimental drug (investigational product) within four weeks before joining the study.
Currently taking a TKI (tyrosine kinase inhibitor) because of specific genetic changes called ABL‑class translocations in the leukemia (found in Ph‑like ALL).
Having a known serious allergy (hypersensitivity) to the study drug, its ingredients, or any other medication that will be given during the trial.
Having any medical reason that makes the special chemotherapy used to lower immune cells (lymphodepleting chemotherapy regimen) unsafe for you.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Charite Universitaetsmedizin Berlin KöR
Berlin, Germany
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Goethe University Frankfurt
Frankfurt, Germany
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Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Munich, Germany

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Investigated drugs

AUTO1 is a personalized cell therapy. In this treatment, doctors take a small number of your own immune cells (T cells) from your blood, grow them in the lab, and modify them so they can recognize and attack leukemia cells that have specific markers called CD19 and CD22. After the cells are engineered, they are given back to you through an intravenous infusion, where they travel through your bloodstream to find and kill the remaining cancer cells. This approach aims to help prevent the disease from coming back by using your own immune system to target the leukemia.

Autologous Enriched T Cells Retrovirally Transduced To Express Two Chimeric Antigen Receptors Targeting Cd19 And Cd22

What is already known about the treatment

AUTO1 - AUTO1 is given by an IV infusion of a patient’s own T cells that have been modified in the lab to carry two special receptors that recognize CD19 and CD22 on leukemia cells. The product is still experimental and is being studied in a phase II trial for patients with a specific type of acute lymphoblastic leukemia who still have measurable disease after initial treatment. It works by directing the engineered T cells to attach to the cancer cells and trigger their destruction. AUTO1 belongs to the class of cellular immunotherapies known as CAR‑T cell therapy.

Investigated diseases

Philadelphia chromosome‑negative CD19‑positive B‑precursor acute lymphoblastic leukemia - Acute lymphoblastic leukemia is a cancer of immature white blood cells that forms in the bone marrow. In this type, the malignant cells are early B‑cell precursors that lack the Philadelphia chromosome but express the CD19 marker. Patients are often in their first complete remission after initial therapy, yet a molecular failure is identified when very low levels of leukemia cells (MRD ≥ 10⁻⁴) remain after the second induction phase. This residual disease can increase over time, leading to a return of leukemia cells in the bone marrow or other sites. The disease may later present as a morphological relapse with a higher percentage of abnormal lymphoblasts or as spread to the central nervous system or other tissues.