Phase I/II Study of CAR.70- Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapse/Refractory Hematological Malignances

Phase 1

Recruiting

• Conditions: Acute Myeloid Leukemia (AML); B-Cell Lymphoma; Myelodysplastic Syndromes (MDS)
• Interventions: Drug: CAR.70/IL15-transduced CB-NK cells; Drug: Cyclophosphamide; Drug: Fludarabine phosphate

• Registration Number: NCT05092451
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

The goal of this clinical research study is to learn about the safety of giving immune cells called natural killer (NK) cells with chemotherapy to patients with leukemia, lymphoma, or multiple myeloma.

Immune system cells (such as NK cells) are made by the body to attack foreign or cancerous cells. Researchers think that NK cells you receive from a donor may react against cancer cells in your body, which may help to control the disease.

Detailed Description

Primary Objective:

To determine the safety, efficacy and optimal cell dose of CAR.70/IL15-transduced CB-NK cells in patients with relapsed/refractory hematological malignances. The efficacy and optimal dose will be identified for individual diseases.

Secondary Objectives:

* To quantify persistence of infused allogeneic donor CAR-transduced CB-derived NK cells in the recipient.

* To conduct comprehensive immune reconstitution studies.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-10-13
• Study First Submitted QC: 2021-10-13
• Study First Posted: 2021-10-25
• Study Start: 2022-11-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-25
• Primary Completion: 2026-08-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CAR.70/IL15-transduced CB-NK cells	CAR.70/IL15-transduced CB-NK cells	Patients will receive a single flat dose of CAR-NK.
Fludarabine phosphate	Fludarabine phosphate	Fludarabine is dosed using actual body weight.
Cyclophosphamide	Fludarabine phosphate	Cyclophosphamide is dosed per adjusted body weight for patients weighing \> 20% above their ideal body weight using the calculation.
Cyclophosphamide	Cyclophosphamide	Cyclophosphamide is dosed per adjusted body weight for patients weighing \> 20% above their ideal body weight using the calculation.
Fludarabine phosphate	Cyclophosphamide	Fludarabine is dosed using actual body weight.

Primary Outcome Measures

Name	Time	Method
Number of Participants with Complete or Partial Response	Up to 30 days after the last treatment
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0.	through study completion, an average of 1 year	CTCAE Version 5.0 - General grading: Grade 1: Mild: discomfort present with no disruption of daily activity, no treatment required beyond prophylaxis.; Grade 2: Moderate: discomfort present with some disruption of daily activity, require treatment.; Grade 3: Severe: discomfort that interrupts normal daily activity, not responding to first line treatment.; Grade 4: Life Threatening: discomfort that represents immediate risk of death
Number of Participants who are Alive and in Remission	Up to 180 days	Number of Participants who are Alive and in Remission after 6 months.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States