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OtherClinical Investigations (Human)

First-in-human imaging with 89Zr-Df-IAB22M2C anti-CD8 minibody in patients with solid malignancies: preliminary pharmacokinetics, biodistribution, and lesion targeting

Neeta Pandit-Taskar, Michael Postow, Matthew Hellmann, James Harding, Christopher Barker, Joseph O'Donoghue, Martha Ziolkowska, Shutian Ruan, Serge Lyashchenko, Frank Tsai, Michael Farwell, Tara Mitchell, Ron Korn, William Le, Jason Lewis, Wolfgang Weber, Deepak Behera, Ian Wilson, Michael Gordon, Anna Wu and Jedd Wolchok
Journal of Nuclear Medicine October 2019, jnumed.119.229781; DOI: https://doi.org/10.2967/jnumed.119.229781
Neeta Pandit-Taskar
1 Memorial Sloan Kettering Cancer Center, United States;
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Michael Postow
1 Memorial Sloan Kettering Cancer Center, United States;
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Matthew Hellmann
1 Memorial Sloan Kettering Cancer Center, United States;
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James Harding
1 Memorial Sloan Kettering Cancer Center, United States;
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Christopher Barker
1 Memorial Sloan Kettering Cancer Center, United States;
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Joseph O'Donoghue
1 Memorial Sloan Kettering Cancer Center, United States;
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Martha Ziolkowska
1 Memorial Sloan Kettering Cancer Center, United States;
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Shutian Ruan
1 Memorial Sloan Kettering Cancer Center, United States;
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Serge Lyashchenko
1 Memorial Sloan Kettering Cancer Center, United States;
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Frank Tsai
2 Honor Health;
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Michael Farwell
3 University of Pennsylvania;
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Tara Mitchell
3 University of Pennsylvania;
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Ron Korn
4 Imaging Endpoints;
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William Le
5 ImaginAb, Inc.
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Jason Lewis
1 Memorial Sloan Kettering Cancer Center, United States;
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Wolfgang Weber
1 Memorial Sloan Kettering Cancer Center, United States;
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Deepak Behera
5 ImaginAb, Inc.
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Ian Wilson
5 ImaginAb, Inc.
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Michael Gordon
2 Honor Health;
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Anna Wu
5 ImaginAb, Inc.
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Jedd Wolchok
1 Memorial Sloan Kettering Cancer Center, United States;
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Abstract

Immunotherapy is becoming the mainstay for treatment of a variety of malignancies, but only a subset of patients respond to treatment. Tumor-infiltrating CD8-positive (CD8+) T lymphocytes play a central role in anti-tumor immune responses. Non-invasive imaging of CD8+ T cells may provide new insights into the mechanisms of immunotherapy and potentially predict treatment response. We are studying the safety and utility of 89Zr-IAB22M2C, a radiolabeled minibody against CD8+ T cells, for targeted imaging of CD8+ T cells in patients with cancer. Methods: The intial dose escalation phase of this first-in-human prospective study included 6 patients (melanoma, 1; lung, 4; HCC, 1). Patients received approximately 111 MBq (3 mCi) of 89Zr-IAB22M2C (at minibody mass doses of 0.2, 0.5, 1.0, 1.5, 5, or 10 mg) as a single dose, followed by PET/CT scans at ~1-2, 6-8, 24, 48, and 96–144 h post-injection (p.i.). Biodistribution in normal organs, lymph nodes, and lesions was evaluated. In addition, serum samples were obtained at ~5, 30, and 60 min and later at the times of imaging. Patients were monitored for safety during infusion and up to the last imaging time point. Results: 89Zr-IAB22M2C infusion was well tolerated with no immediate or delayed side effects observed after injection. Serum clearance was typically bi-exponential and dependent on the mass of minibody administered. Areas under the serum time-activity curve normalized to administered activity ranged from 1.3 h/l for 0.2 mg to 8.9 h/l for 10 mg. Biodistribution was dependent on the minibody mass administered. The highest uptake was always seen in spleen, followed by bone marrow. Liver uptake was more pronounced with higher minibody masses. Kidney uptake was typically low. Prominent uptake was seen in multiple normal lymph nodes as early as 2 h p.i., reaching peak levels by 24–48 h p.i. Uptake in tumor lesions was seen on imaging as early as 2 h p.i., with a majority of 89Zr-IAB22M2C-positive lesions detectable by 24 h. Lesions were visualized early in patients receiving treatment, with SUV ranging from 5.85–22.8 in 6 target lesions. Conclusion: 89Zr-IAB22M2C imaging is safe and has favorable kinetics for early imaging. Biodistribution suggests successful targeting of CD8+ T cell-rich tissues. The observed targeting of tumor lesions suggests this may be informative for CD8+ T cell accumulation within tumors. Further evaluation is underway.

  • Monoclonal Antibodies
  • PET
  • Radioimmunoimaging
  • 89Zr-IAB22M2C PET
  • CD8+ T cell
  • lung cancer
  • melanoma
  • minibody
  • Copyright © 2019 by the Society of Nuclear Medicine and Molecular Imaging, Inc.
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Journal of Nuclear Medicine: 62 (4)
Journal of Nuclear Medicine
Vol. 62, Issue 4
April 1, 2021
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First-in-human imaging with 89Zr-Df-IAB22M2C anti-CD8 minibody in patients with solid malignancies: preliminary pharmacokinetics, biodistribution, and lesion targeting
Neeta Pandit-Taskar, Michael Postow, Matthew Hellmann, James Harding, Christopher Barker, Joseph O'Donoghue, Martha Ziolkowska, Shutian Ruan, Serge Lyashchenko, Frank Tsai, Michael Farwell, Tara Mitchell, Ron Korn, William Le, Jason Lewis, Wolfgang Weber, Deepak Behera, Ian Wilson, Michael Gordon, Anna Wu, Jedd Wolchok
Journal of Nuclear Medicine Oct 2019, jnumed.119.229781; DOI: 10.2967/jnumed.119.229781

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First-in-human imaging with 89Zr-Df-IAB22M2C anti-CD8 minibody in patients with solid malignancies: preliminary pharmacokinetics, biodistribution, and lesion targeting
Neeta Pandit-Taskar, Michael Postow, Matthew Hellmann, James Harding, Christopher Barker, Joseph O'Donoghue, Martha Ziolkowska, Shutian Ruan, Serge Lyashchenko, Frank Tsai, Michael Farwell, Tara Mitchell, Ron Korn, William Le, Jason Lewis, Wolfgang Weber, Deepak Behera, Ian Wilson, Michael Gordon, Anna Wu, Jedd Wolchok
Journal of Nuclear Medicine Oct 2019, jnumed.119.229781; DOI: 10.2967/jnumed.119.229781
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  • Imaging the Cancer Immune Environment and Its Response to Pharmacologic Intervention, Part 2: The Role of Novel PET Agents
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  • The PET-Tracer 89Zr-Df-IAB22M2C Enables Monitoring of Intratumoral CD8 T-cell Infiltrates in Tumor-Bearing Humanized Mice after T-cell Bispecific Antibody Treatment
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Keywords

  • monoclonal antibodies
  • PET
  • Radioimmunoimaging
  • 89Zr-IAB22M2C PET
  • CD8+ T cell
  • lung cancer
  • Melanoma
  • minibody
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