RecruitingPhase 1

Anti-CD7 CAR-T Cells in Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia or Lymphoma

A Phase 1 Study of Allogeneic Anti-CD7 CAR-T Cells (BEAM-201) in Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL) or T-cell Lymphoblastic Lymphoma (T-LLy)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
0 Years to 29 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This Phase 1 study tests BEAM-201 for safety and how well it works. It uses donor immune cells changed to target CD7, a marker on cancer cells. It is for people ages 0 to 29 with T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LLy) that has returned or resisted treatment.

This will be a Phase 1, open-label study to evaluate the safety and efficacy of BEAM-201 in patients with R/R T-ALL or T-LLy. BEAM-201 is an allogeneic anti-CD7 CART therapy.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 0 to 29. You or your parent or legal guardian must sign a consent form.
  • Have cancer that has returned at least twice, returned after a donor stem cell transplant, or resisted chemotherapy. Certain mixed-type leukemias mainly involving T cells may also qualify.
  • Have CD7 on at least 90% of the tested cancer cells.
  • If cancer affects the brain or spinal cord, it must respond to treatment.
  • Be able to receive strong chemotherapy and a donor stem cell transplant, with a donor identified by an accredited transplant center.
  • Have a score of at least 50 on the study's scale for daily activity and ability to care for yourself.
  • Meet the study's kidney, liver, lung, and heart function requirements. Some liver test changes caused by leukemia are allowed.
  • Have a negative pregnancy test if you can become pregnant. If sexually active and able to have children, agree to highly effective birth control from consent until 12 months after treatment.

Who can't join

  • Have active hepatitis B, hepatitis C, or HTLV infection; HIV; or an active bacterial, viral, or fungal infection that is not controlled.
  • Have cancer in the brain or spinal cord that worsens during treatment, risky spots in brain tissue, active brain or spinal cord problems, or permanent nerve damage from earlier leukemia treatment.
  • Have had treatment targeting CD7, or radiation within 2 weeks before screening ends, unless it was to prevent cancer in the brain or spinal cord.
  • Have had a stem cell transplant within 90 days or a donor white blood cell infusion within 30 days before screening ends. Certain donor-cell attacks on your body requiring immune-suppressing drugs also exclude you.
  • Have another condition that prevents a stem cell transplant, a known inherited immune system problem, or a bone marrow failure disorder.
  • Have certain serious heart problems, including abnormal rhythms, fluid around the heart, severe heart weakness, or a heart attack within the past 12 months.
  • Have an autoimmune disease needing immune-suppressing drugs that cannot safely be stopped for 3 months. Steroids for conditions other than this cancer are not allowed, except replacement treatment for low adrenal hormones.
  • Be pregnant or breastfeeding.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Patients must meet all the following criteria to be eligible for enrollment into the study: 1. Patients (ages ≥ 18 years) or parent/legal guardians (for patients ages \< 18 years) must provide signed, written informed consent according to local IRB and institutional requirements. 2. Ages 0 to 29 years. 3. T-ALL/T-LLy in second or greater relapse, first relapse post-transplant, or chemotherapy-refractory disease. Specifically: 1. Second or greater relapse or post-transplant relapse, defined as: * BM with ≥ 5% lymphoblasts by morphologic assessment or evidence of extramedullary disease after second documented CR; OR * Flow cytometric confirmation of relapsed T-ALL of at least 0.1% after second CR documented to have been MRD negative \< 0.1%; OR * Any detectable relapsed disease post-allogeneic HSCT with flow cytometric confirmation of T-ALL of at least 0.1%; OR * Biopsy confirmed evidence of relapsed T-LLy after second CR; OR * Any detectable disease post-allogeneic transplant with biopsy confirmed evidence of T-LLy 2. Refractory disease, defined as: * Primary refractory T-ALL or T-LLy, defined as failure to achieve CR after induction chemotherapy, per investigator assessment and based on biopsy-or MRD-confirmed evidence of residual T-ALL or T-LLy; OR * Relapsed, refractory disease, defined as \> 0.1 % MRD or morphologic evidence of disease or evidence of residual T-LLy after 1 course of re-induction chemotherapy for patients who have relapsed after previously achieving a CR NOTE: Patients with mixed phenotype acute leukemia with T cell dominant phenotype may be enrolled if the aforementioned criteria are met. 4. Documentation of CD7 expression on leukemic or T-LLy blasts (defined as at least 90% of blasts positive for CD7 by flow cytometry or immunohistochemistry). 5. Patients with prior or current history of CNS3 disease will be eligible if CNS disease is responsive to therapy 6. Eligible for myeloablative conditioning for and allogeneic HSCT based on the investigator's assessment with an available donor identified by a FACT accredited transplant center. 7. Lansky Performance Status (ages \< 16 years at time of consent) or Karnofsky Performance Status (KPS) (ages ≥ 16 years at time of consent) score of ≥ 50. 8. Patients of childbearing potential must have a negative urine or serum pregnancy test at screening. 9. Adequate organ function defined as: 1. Adequate Serum creatinine based on age/gender 2. ALT ≤ 5x ULN in the absence of ALL infiltration of the liver 3. Bilirubin ≤ 3 × ULN for age Note: ALT and/or bilirubin results that exceed this range are acceptable if, in the opinion of the physician-investigator (or as confirmed by liver biopsy), the abnormalities are directly related to ALL infiltration of the liver. 4. Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and \<Grade 3 hypoxia; DLCO ≥40% (corrected for anemia if necessary) if PFTs are clinically appropriate as determined by the investigator. 5. Cardiac echocardiography (ECHO) with left ventricular shortening fraction (LVSF) ≥ 30% or left ventricular ejection fraction (LVEF) ≥ 50%. In cases where quantitative assessment of LVSF/LVEF is not possible, a statement by the cardiologist that the ECHO shows qualitatively normal ventricular function will suffice 10. Patients who are sexually active and of reproductive potential must agree to use an acceptable form of highly effective contraception from consent to 12 months after BEAM 201 infusion. 4.2 Exclusion Criteria Patients who meet any of the following criteria will be disqualified from entering the study: 1. Active hepatitis B or active hepatitis C 2. Active HTLV infection 3. HIV infection 4. Uncontrolled, active bacterial, viral, or fungal infection. 5. CNS disease that is progressive on therapy, or with CNS parenchymal lesions that might increase the risk of CNS toxicity. 6. Clinically active CNS dysfunction or known history of irreversible central neurological toxicity related to prior antileukemic therapy. 7. Receipt of prior CD7 targeted therapy. 8. Radiation therapy within 2 weeks prior to completion of screening, other than prophylaxis for CNS disease. 9. Acute GVHD that is grade ≥ 2 and requiring systemic immunosuppression (corticosteroids), or chronic GVHD that is mild, moderate, or severe and requiring systemic immunosuppression (corticosteroids). Grade 1 acute GVHD not requiring immunosuppression is allowable. 10. Undergone HSCT within 90 days prior to completion of screening (or donor leukocyte infusion, if received within 30 days prior to completion of screening). 11. Any other condition that would make the patient ineligible for HSCT as determined by the investigator. 12. Known primary immunodeficiency or BM failure syndrome. 13. Atrial fibrillation/flutter (not including isolated episodes that responded to medical management) 14. Clinically significant pericardial effusion 15. Myocardial infarction within the last 12 months 16. QT interval corrected for heart rate \> 480 msec 17. Cardiac dysfunction NYHA (New York Heart Association) III or IV 18. Patients with an autoimmune disorder requiring systemic immunosuppressive therapy that cannot be safely withheld for 3 months. Concurrent use of systemic corticosteroids for diagnoses unrelated to T-ALL/T-LLy is prohibited, with exception of physiologic corticosteroid replacement therapy treatment for adrenal insufficiency. 19. Pregnant or breastfeeding

Study sites (1)

PA