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

ConditionT-Cell Acute Lymphoblastic Leukemia/Lymphoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age0-29
SponsorStephan Grupp MD PhD

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Ages 0 to 29 years.

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

Disqualifiers

Active hepatitis B or active hepatitis C

Active HTLV infection

HIV infection

Uncontrolled, active bacterial, viral, or fungal infection.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Allogeneic anti-CD7 CAR-T cells (BEAM-201)

    Biological/Vaccine

    The investigational agent in this protocol is allogeneic anti-CD7 CART cells (BEAM-201). BEAM-201 is comprised of allogeneic anti-CD7 CAR-T cells edited by 4 gRNAs and a single mRNA encoding a CBE, then transduced with a lentiviral vector (LVV) encoding the anti-CD7 chimeric antigen receptor (CAR) molecule.

Treatment groups

33 Participants
are divided into 2 treatment groups
Group A: Dose Escalation ArmExperimental treatment 1 intervention
Group B: Dose Expansion ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Determine the Maximum Tolerate Dose of Beam 201 Cells

The Maximum Tolerated Dose will be determined by measuring the incidence of dose limiting toxicities following administration of the product.

Time frame
5 years
2

Frequency of Adverse Events Following Beam-201 administration

Frequency of Adverse events will be measured by evaluating the frequency and severity of treatment related adverse events following administration of Beam-201 Cells

Time frame
5 years

Secondary outcomes

1

• Determine the overall response rate following BEAM-201 infusion

Defined as the frequency of patients who achieve complete remission or partial response following treatment with Beam 201

Time frame
5 years
2

Determine depth of response based on MRD for patients with clinical responses following BEAM-201 infusion

Evaluated as the frequency of patients who have minimal residual disease through next generation sequencing

Time frame
5 years
3

Determine the proportion of patients treated with BEAM-201 who are deemed appropriate for stem cell transplant

As evaluated the percentage of patients who proceed to stem cell transplant following Beam-201 administration

Time frame
5 years
4

• Determine duration of response for patients with clinical responses following BEAM 201 infusion

Duration of Response will be measured by the average number of months in remission after Beam 201 administration

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stephan Grupp MD PhD

Lead sponsor

Children's Hospital of Philadelphia

Sponsor institution

Beam Therapeutics Inc.

Collaborator

Source ClinicalTrials.gov
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